■ Robotic surgery reduces blood loss, decreases length of hospital stay, decreases postoperative pain, and improves recovery time.
■ Robotic surgery is particularly useful in gynecologic surgery because of the limited space within the pelvic cavity.
■ The versatility of robotic instruments has expanded the range of gynecologic conditions amenable to minimally invasive surgery.
■ The cost of setting up and maintaining robotic surgical systems can be prohibitive.
■ Studies that evaluate long-term outcomes of robotic surgery are needed to further validate the place of robots in the OR.
Over the past two decades, minimally invasive surgery has progressed beyond all expectations. Many operations that used to require laparotomy are now routinely performed using laparoscopic techniques. Appendectomies, cholecystectomies, and even hysterectomies are done through keyhole-size incisions that are aesthetically pleasing to the patient and less costly in terms of postoperative pain, length of hospital stay, and blood loss. Conventional laparoscopic surgery, however, is not without its limitations. Difficulties such as tremor amplification, reverse fulcrum, and loss of dexterity create problems for the surgeon, limiting the potential of the laparoscope.1 Fortunately, with the help of robotic technology, many of these problems can be overcome. With names that conjure up images of the great works of Italian masters, robots are challenging surgeons to learn the art and the science of a new type of surgery. Robotic technology is revolutionizing minimally invasive surgery.
HISTORY OF ROBOTIC SURGERY
Robotic surgery was first conceived as a way to facilitate surgery performed on military personnel injured in the field. The intent was to enable surgeons to operate remotely, reducing the risk to the surgeon and increasing the speed of delivery of potentially lifesaving treatment to the patient. With the development of a remote console (surgeon control center), a patient side cart (engages robotic arms), and a vision cart (camera display), surgery that did not require the surgeon to lay hands on the patient became possible. As robotic capabilities became more sophisticated, robotic surgery moved away from the battlefield and directly into the OR. Although many robotic models have been developed over the years, currently the only FDA-approved robotic platform is the da Vinci Surgical System. The da Vinci platform was approved for use in urology in 2000 and then for gynecology in 2005.2 This article focuses primarily on the application of robotic technology to gynecology, given the tremendous potential of robot-assisted laparoscopic surgery in this field.
INCREASED FLEXIBILITY AND PRECISION
IN GYNECOLOGIC SURGERY
Robotic surgery is particularly useful in gynecologic surgery because of its flexibility within the limited space of the pelvic cavity. Traditional laparoscopic instruments are awkward to maneuver in the tight confines of the pelvis. This difficulty
is compounded by other problems associated with conventional laparoscopy including the following: reverse fulcrum (counterintuitive movements), tremor amplification, ergonomic challenges, and tissue visualization that is only two-
dimensional (2D). Robotic platforms overcome many of these problems. The surgeon moves the robotic arms and cameras using hand controls and foot pedals. Movements of robotic instruments mimic those of the surgeon's hands, eliminating the reverse fulcrum effect. Previously, operators needed to move their hands in the opposite direction of the one they desired, but robotics allow surgeons to move their hands in the direction they want the instruments to move. This feature improves precision and control, facilitating procedures on very delicate tissues.3
The EndoWrist instrument tip of the da Vinci robotic system moves in multiple directions, offering the operator 7 degrees of freedom, greater articulation, and a degree of dexterity comparable to that of the human hand. This improves the surgeon's ability to grasp, cut, dissect, cauterize, and suture fragile tissues within the tight confines of the pelvic cavity. Tremor is eliminated as well.
IMPROVED VISUALIZATION AND COMFORT
The da Vinci Surgical System has cameras that provide the surgeon with 3D, high-definition images of the operative field, improving visualization of blood vessels, tissues, and nerves. The surgeon can magnify images and zoom in on targets while looking through the vision screen. This improved clarity increases accuracy and compensates somewhat for the loss of haptic (tactile) feedback that is inherent in robotic surgery.
Robotic technology also reduces the ergonomic challenges of classic laparoscopy. The surgeon is seated at the remote console, obviating the need to be a contortionist to manipulate the instruments into the desired position. This increases surgeon comfort and decreases fatigue, helping the surgeon focus attention on the work at hand and providing for complex gynecologic surgeries that require longer OR time. As a result of these developments, the range of gynecologic conditions amenable to minimally invasive surgery has increased along with the number of patients who benefit from this technique. Surgeries such as sacrocolpopexy, myomectomy, and cancer staging can now be done without laparotomy.4
RISKS AND BENEFITS
As the scope of robotic gynecologic surgery continues to expand, increasing numbers of patients will ask PAs about the risks and benefits of this surgery. Already, radio and television commercials promote robotics as a reason to select a particular hospital. Tuned-in patients will no doubt start to question PAs about the efficacy of robotic hysterectomy, tubal reversal, and myomectomy: Is my uterus really safe in the hands of a "droid"? Consequently, knowing some of the published data relating to this surgery is both useful and necessary.
Multiple research studies have shown that minimally in vasive surgery significantly reduces blood loss, decreases post operative pain, shortens hospital stay, and decreases morbidity. Patients need less analgesia, recover faster, and benefit from a quicker return to their usual activities. These benefits hold true for a wide range of gynecologic surgeries and apply to both robot-assisted and conventional laparoscopic surgery. Recent studies, however, demonstrate that the advantages for patients may be even greater using robotics.3-5
Several studies have shown that robotic surgery is superior to conventional laparoscopic surgery for suturing, knot tying, and lysis of adhesions. These findings support the premise that robot-assisted surgery is a cut above conventional laparoscopic surgery, especially for those patients who have scarring or adhesions.2Payne and Dauterive compared surgical outcomes for 200 total laparoscopic hysterectomies to robot-assisted hysterectomies. They concluded that robotic surgery halved blood loss, shortened hospital stay, and reduced conversions to laparotomy. Laparotomy remains the primary method of performing myomectomy, as conventional laparoscopy is difficult due to problems with enucleation, removal, and multi-layer suturing. Robotic surgery overcomes many of these problems, offering patients an effective treatment for their fibroids plus the advantages of minimally invasive surgery.4
Robot-assisted gynecologic surgery for cancer staging has many benefits. Boggess and colleagues compared robot-assisted staging with laparoscopic staging for endometrial cancer. The robotic approach was associated with decreased length of hospital stay, an increase in the number of nodes retrieved, and less blood loss. Robotics had the added benefit of allowing staging on obese women who otherwise would have needed laparotomy.6
As the United States population ages, PAs are likely to encounter increasing numbers of patients with pelvic organ prolapse. Repair of prolapse is not usually conducive to conventional laparoscopic techniques, as surgeons encounter technical difficulties with mesh placement, knot tying, tissue dissection, and suturing. The robotic approach alleviates many of these difficulties, making minimally invasive surgery a more viable option.7
OTHER FACTORS TO CONSIDER
Several other important factors need to be considered by PAs when discussing robotics with patients. Robotic surgery is more expensive than conventional laparoscopic surgery and laparotomy. Learning curves are steep for surgeons, initially resulting in longer operating times for patients as new skills are learned. Robotic surgery precludes haptic feedback, as it denies the surgeon the ability to palpate the tissues. The lack of direct physical and visual contact between the patient and operator may raise ethical concerns, particularly in situations where the surgeon is situated at a considerable distance from the patient. Information may not be secure and communication may break down. Finally, studies that evaluate long-term outcomes of robot-assisted gynecologic surgery are needed to assess survival, effects on quality of life, postoperative function, and durability.8 Nonetheless, a growing body of evidence supports the premise that robots represent a significant advance in the field of gynecologic surgery, reaping considerable benefits for patients and clinicians. Source: JAAPA
Sunday, October 17, 2010
Thursday, October 14, 2010
Stöpler to Distribute Z-Medica QuikClot Products for the First Time to Hospitals in The Netherlands
WALLINGFORD, Conn.--(Healthcare Sales & Marketing Network)-- Z-Medica Corporation, a medical device company developing innovative hemostatic agents, today announced that it has signed an exclusive distribution agreement with Stöpler, a supplier of medical instruments, equipment and disposables to hospitals in the Netherlands, Belgium and Luxembourg. Stöpler will have the exclusive rights to sell and distribute Z-Medica’s full line of QuikClot® hemostatic agents to hospitals and healthcare professionals in The Netherlands.
QuikClot products received CE Mark from the European Union in November 2009 and the company has been negotiating distribution agreements with a series of best-of-breed medical device distributors such as Stöpler in European markets since then.
“Bleeding is a problem across the globe, and Z-Medica is aiming to reach beyond the U.S. borders with revolutionary gauze products that are proven effective in some of the most traumatic of circumstances,” said Brian Herrman, Chief Executive Officer, Z-Medica. “We are proud to work with partners like Stöpler, who see the need to have QuikClot in every hospital and carried by all healthcare professionals.”
QuikClot is a surgical gauze impregnated with kaolin, an inert mineral with no known contraindications, and can achieve hemostasis in severe bleeding situations in as little as three minutes. QuikClot is widely used throughout several clinical specialties, including cardiology, interventional radiology, critical care, dermatology, emergency medicine, orthopedics and OB/Gyn, and after months of testing against 12 other hemostatic products in the marketplace, the military version of the kaolin gauze (“Combat Gauze”) was chosen as the exclusive product for use by all US Military Forces in 2008. It continues to be the exclusive product used by all USA military forces for first line treatment of bleeding hemorrhage.
“Our focus is on providing healthcare professionals throughout The Netherlands access to premium brands such as QuikClot, and we are thrilled with the opportunity to provide our partners with this line of life saving devices,” said Eric Knuiman, General Manager of Stöpler. “We foresee great demand for this product as it is not only safe and effective, but also diverse in its applications.”
QuikClot products received CE Mark from the European Union in November 2009 and the company has been negotiating distribution agreements with a series of best-of-breed medical device distributors such as Stöpler in European markets since then.
“Bleeding is a problem across the globe, and Z-Medica is aiming to reach beyond the U.S. borders with revolutionary gauze products that are proven effective in some of the most traumatic of circumstances,” said Brian Herrman, Chief Executive Officer, Z-Medica. “We are proud to work with partners like Stöpler, who see the need to have QuikClot in every hospital and carried by all healthcare professionals.”
QuikClot is a surgical gauze impregnated with kaolin, an inert mineral with no known contraindications, and can achieve hemostasis in severe bleeding situations in as little as three minutes. QuikClot is widely used throughout several clinical specialties, including cardiology, interventional radiology, critical care, dermatology, emergency medicine, orthopedics and OB/Gyn, and after months of testing against 12 other hemostatic products in the marketplace, the military version of the kaolin gauze (“Combat Gauze”) was chosen as the exclusive product for use by all US Military Forces in 2008. It continues to be the exclusive product used by all USA military forces for first line treatment of bleeding hemorrhage.
“Our focus is on providing healthcare professionals throughout The Netherlands access to premium brands such as QuikClot, and we are thrilled with the opportunity to provide our partners with this line of life saving devices,” said Eric Knuiman, General Manager of Stöpler. “We foresee great demand for this product as it is not only safe and effective, but also diverse in its applications.”
Wednesday, October 13, 2010
Quantum award recognizes the potential of this research to revolutionize cardiovascular care for millions of patients
Danny Bluestein, Ph.D., Professor of Biomedical Engineering at Stony Brook University, has been awarded a five-year, $7.5 million grant by the National Institutes of Health. The award marks the first time a Stony Brook professor has received a Phase II Quantum Grant, given by The National Institute of Biomedical Imaging and Bioengineering (NIBIB), a division of the NIH, to make a profound improvement—or quantum leap forward—in health care.
Dr. Bluestein’s project involves testing and optimizing the designs of various cardiovascular devices with the goal to eliminate the need for anticoagulation therapy for patients with these devices.
Millions of cardiovascular disease patients worldwide are implanted with prosthetic devices. While these devices save lives, they promote blood clot formation and patients are required to take anticoagulants, which may slow the rate at which the patient’s blood clots. There are numerous conditions for which cardiovascular patients take anticoagulants. Most patients with prosthetic heart valves, left ventricular assist devices (LVADs), and biventricular assist devices (BiVADs), need to take anticoagulants. The downsides to this class of drugs are that blood clot formation is not eliminated and there is a risk for dangerous and potentially deadly bleeds if therapy is not properly monitored.
“Dr. Bluestein’s work is certain to contribute to our understanding of cardiovascular disease and pave new ways of treating heart dysfunction,” says Clinton T. Rubin, Ph.D., Director of the Center for Biotechnology, Distinguished SUNY Professor, and Chair of the Department of Biomedical Engineering at SBU.
“The Quantum award recognizes the potential of this research to revolutionize cardiovascular care for millions of patients,” says Kenneth Kaushansky, M.D., Senior Vice President, Health Sciences, and Dean, SBU School of Medicine. “Dr. Bluestein’s work stands out as the kind of translational research that is necessary to advance cardiovascular care even more than it has already progressed within the past decade.”
“We developed a Device Thrombogenicity Emulator (DTE) that measures the potential for blood clotting in cardiovascular devices by mimicking the conditions in the device, as extracted from sophisticated numerical simulations,” says Dr. Bluestein. “The DTE measures the formation of blood clots in an emulated device environment, facilitating the optimization of these devices without the need to build expensive prototypes and test them before optimization is achieved.
“This has a tremendous potential to significantly reduce the ensuing healthcare costs while improving the quality of life for patients with implanted devices,” he explains, likening the concept to wind tunnels used for aeronautic and automotive testing.
During Phase I of the project, Dr. Bluestein and his colleagues developed and tested the DTE, which reduced the need for anticoagulation in laboratory models. During Phase II, he expects to use the DTE to identify ‘hot spot’ trajectories in the flow fields of cardiovascular devices, where clots can form.
“Within the DTE, we can tweak the geometry of the device’s design to optimize it and minimize or eliminate these hot spots,” he notes.
According to Dr. Bluestein, the researchers recently demonstrated in numerical simulations and in the DTE (where clot formation is also measured) that an optimized design of the HeartAssist5, the modern DeBekay LVAD, clot formation was reduced by an order of magnitude. Concurrent animal experiments using the optimized device were conducted by Micromed Inc.—the company that manufactures the device—and the results indicates that its recipients may not require anticoagulation.
Dr. Bluestein is working with various institutions and companies to use the DTE to test and optimize the designs of various prosthetic heart valves, LVADs, BiVADs and the only Food and Drug Administration (FDA)-approved total artificial heart. He envisions the methodology as becoming an FDA standard for testing such medical devices.
“The work of Dr. Bluestein and colleagues contributes enormously to the bridging of our College of Engineering and Applied Sciences to the School of Medicine,” states Yacov Shamash, Ph.D., Vice President for Economic Development, and Dean of the College of Engineering and Applied Science at SBU. “We are excited to see this marriage of engineering and medicine that should lead to great advances in health care.”
The Quantum Grants Program of NIBIB challenges the research community to propose projects that have an innovative, highly focused, collaborative, and interdisciplinary approach targeted to solve a major medical problem or to resolve a highly prevalent technology-based medical challenge. The mission of NIBIB is to improve health by leading the development and accelerating the application of biomedical technologies.
Collaborators on Dr. Bluestein’s project include the Sarver Heart Center at the University of Arizona in Tucson, along with a consortium of four industrial partners: SynCardia Systems, Inc.; MicroMed Cardiovascular, Inc.; Medtronic-ATS Medical Inc., and Innovia LLC. Co-investigators at Stony Brook include Department of Medicine Professor Jolyon Jesty, and Professor Shmuel Einav of the College of Engineering and Applied Science.
Dr. Bluestein, Director of the Biofluids Laboratory in the SBU Biomedical Engineering Department, has been with the department since 1996. In 1992, he received his Ph.D. in Mechanical and Biomedical Engineering from Tel Aviv University in Tel Aviv, Israel, where he also earned an M.S. in Mechanical Engineering in 1985. He received a B.S. in Aeronautical Engineering from the Technion-Israel Institute of Technology in 1981.
In 2010, Professor Bluestein was elected into the American Institute for Medical and Biological Engineering’s (AIMBE) College of Fellows, in recognition of his exceptional leadership and achievements in medical and biological engineering.
The Department of Biomedical Engineering at Stony Brook University is one of 25 departments within the School of Medicine and is part of the College of Engineering and Applied Sciences. Established in 2000, the department includes more than 60 faculty training students in undergraduate, MS and PhD programs. Areas of research emphasis include Biomechanics & Biomaterials, Bioelectricity & Bioimaging, Tissue Engineering, Bioinstrumentation and Biosignal Processing, and Cell & Molecular Bioengineering
Dr. Bluestein’s project involves testing and optimizing the designs of various cardiovascular devices with the goal to eliminate the need for anticoagulation therapy for patients with these devices.
Millions of cardiovascular disease patients worldwide are implanted with prosthetic devices. While these devices save lives, they promote blood clot formation and patients are required to take anticoagulants, which may slow the rate at which the patient’s blood clots. There are numerous conditions for which cardiovascular patients take anticoagulants. Most patients with prosthetic heart valves, left ventricular assist devices (LVADs), and biventricular assist devices (BiVADs), need to take anticoagulants. The downsides to this class of drugs are that blood clot formation is not eliminated and there is a risk for dangerous and potentially deadly bleeds if therapy is not properly monitored.
“Dr. Bluestein’s work is certain to contribute to our understanding of cardiovascular disease and pave new ways of treating heart dysfunction,” says Clinton T. Rubin, Ph.D., Director of the Center for Biotechnology, Distinguished SUNY Professor, and Chair of the Department of Biomedical Engineering at SBU.
“The Quantum award recognizes the potential of this research to revolutionize cardiovascular care for millions of patients,” says Kenneth Kaushansky, M.D., Senior Vice President, Health Sciences, and Dean, SBU School of Medicine. “Dr. Bluestein’s work stands out as the kind of translational research that is necessary to advance cardiovascular care even more than it has already progressed within the past decade.”
“We developed a Device Thrombogenicity Emulator (DTE) that measures the potential for blood clotting in cardiovascular devices by mimicking the conditions in the device, as extracted from sophisticated numerical simulations,” says Dr. Bluestein. “The DTE measures the formation of blood clots in an emulated device environment, facilitating the optimization of these devices without the need to build expensive prototypes and test them before optimization is achieved.
“This has a tremendous potential to significantly reduce the ensuing healthcare costs while improving the quality of life for patients with implanted devices,” he explains, likening the concept to wind tunnels used for aeronautic and automotive testing.
During Phase I of the project, Dr. Bluestein and his colleagues developed and tested the DTE, which reduced the need for anticoagulation in laboratory models. During Phase II, he expects to use the DTE to identify ‘hot spot’ trajectories in the flow fields of cardiovascular devices, where clots can form.
“Within the DTE, we can tweak the geometry of the device’s design to optimize it and minimize or eliminate these hot spots,” he notes.
According to Dr. Bluestein, the researchers recently demonstrated in numerical simulations and in the DTE (where clot formation is also measured) that an optimized design of the HeartAssist5, the modern DeBekay LVAD, clot formation was reduced by an order of magnitude. Concurrent animal experiments using the optimized device were conducted by Micromed Inc.—the company that manufactures the device—and the results indicates that its recipients may not require anticoagulation.
Dr. Bluestein is working with various institutions and companies to use the DTE to test and optimize the designs of various prosthetic heart valves, LVADs, BiVADs and the only Food and Drug Administration (FDA)-approved total artificial heart. He envisions the methodology as becoming an FDA standard for testing such medical devices.
“The work of Dr. Bluestein and colleagues contributes enormously to the bridging of our College of Engineering and Applied Sciences to the School of Medicine,” states Yacov Shamash, Ph.D., Vice President for Economic Development, and Dean of the College of Engineering and Applied Science at SBU. “We are excited to see this marriage of engineering and medicine that should lead to great advances in health care.”
The Quantum Grants Program of NIBIB challenges the research community to propose projects that have an innovative, highly focused, collaborative, and interdisciplinary approach targeted to solve a major medical problem or to resolve a highly prevalent technology-based medical challenge. The mission of NIBIB is to improve health by leading the development and accelerating the application of biomedical technologies.
Collaborators on Dr. Bluestein’s project include the Sarver Heart Center at the University of Arizona in Tucson, along with a consortium of four industrial partners: SynCardia Systems, Inc.; MicroMed Cardiovascular, Inc.; Medtronic-ATS Medical Inc., and Innovia LLC. Co-investigators at Stony Brook include Department of Medicine Professor Jolyon Jesty, and Professor Shmuel Einav of the College of Engineering and Applied Science.
Dr. Bluestein, Director of the Biofluids Laboratory in the SBU Biomedical Engineering Department, has been with the department since 1996. In 1992, he received his Ph.D. in Mechanical and Biomedical Engineering from Tel Aviv University in Tel Aviv, Israel, where he also earned an M.S. in Mechanical Engineering in 1985. He received a B.S. in Aeronautical Engineering from the Technion-Israel Institute of Technology in 1981.
In 2010, Professor Bluestein was elected into the American Institute for Medical and Biological Engineering’s (AIMBE) College of Fellows, in recognition of his exceptional leadership and achievements in medical and biological engineering.
The Department of Biomedical Engineering at Stony Brook University is one of 25 departments within the School of Medicine and is part of the College of Engineering and Applied Sciences. Established in 2000, the department includes more than 60 faculty training students in undergraduate, MS and PhD programs. Areas of research emphasis include Biomechanics & Biomaterials, Bioelectricity & Bioimaging, Tissue Engineering, Bioinstrumentation and Biosignal Processing, and Cell & Molecular Bioengineering
Hemostatic Powder Market - Cook Rollout of Endoscopic Application
Novel application of powder could eventually replace endoscopic surgical procedure
TORONTO, Ont., October 13, 2010 — A new material similar to that used by the U.S. Military to treat traumatic injuries is showing promise as the next novel treatment for bleeding ulcers, a condition that commonly affects up to 15 per cent of adults, according to Hong Kong physician Dr. James Lau. Dr. Lau is presenting his findings today on this world-first research at the 23rd International Course on Therapeutic Endoscopy. The course is a world-renowned international conference on the latest innovations in endoscopy organized and hosted by St. Michael's Hospital.
"Nearly 5 to 10 per cent of patients who have a bleeding ulcer experience additional bleeding despite our best treatment efforts," said Dr. Lau, a physician at the Prince of Wales Hospital and professor at the Chinese University of Hong Kong. "However, our findings suggest a new approach with a powder that could ultimately prove to be more effective for patients and result in fewer complications."
A preliminary study on the safety of using a proprietary powder from Cook Medical, by Lau and colleagues, found it was beneficial in treating 95 per cent of patients with bleeding peptic ulcers. A peptic ulcer is an oval sore that develops when the lining of the stomach or duodenum is eaten away by stomach acid and digestive juices. First-line treatment involves the use of an endoscope, or a flexible tube, inserted through the mouth into the small intestine and stomach, to treat and repair bleeding ulcers. This is often done by injecting drugs into a blood vessel at the ulcer base or clipping or sealing the ulcer with a probe that generates heat.
In the study, researchers administered the powder through the channel of an endoscope. The powder was applied to the ulcer in one to two short bursts until bleeding stopped. They found the bleeding was successfully stopped in 95 per cent of cases and there was no recurrent bleeding or complications 30 days after treatment. The preliminary findings suggest the powder has high success rates and, most importantly, the technique of applying the powder is simple.
The findings signal future potential uses of the hemostatic powder to treat bleeding ulcers. Dr. Lau's findings is one of many innovative research studies being shared with colleagues around the world through an international conference at the Four Season Hotel in Toronto hosted by endoscopy experts at St. Michael's Hospital.
The Advanced Diagnostic and Therapeutic Endoscopy unit at St. Michael's is a center of excellence in therapeutic interventional and palliative endoscopy. Known worldwide as leaders in the field of endoscopy, physicians on the team have made groundbreaking discoveries and are performing some of the country's only and most innovative endoscopy techniques that allow for the early diagnosis and treatment of cancer.
St. Michael's Hospital provides compassionate care to all who walk through its doors. The Hospital also provides outstanding medical education to future health care professionals in more than 23 academic disciplines. Critical care and trauma, heart disease, neurosurgery, diabetes, cancer care, and care of the homeless are among the Hospital's recognized areas of expertise. Through the Keenan Research Centre and the Li Ka Shing Knowledge Institute, research at St. Michael's Hospital is recognized and put into practice around the world. Founded in 1892, the Hospital is fully affiliated with the University of Toronto.
TORONTO, Ont., October 13, 2010 — A new material similar to that used by the U.S. Military to treat traumatic injuries is showing promise as the next novel treatment for bleeding ulcers, a condition that commonly affects up to 15 per cent of adults, according to Hong Kong physician Dr. James Lau. Dr. Lau is presenting his findings today on this world-first research at the 23rd International Course on Therapeutic Endoscopy. The course is a world-renowned international conference on the latest innovations in endoscopy organized and hosted by St. Michael's Hospital.
"Nearly 5 to 10 per cent of patients who have a bleeding ulcer experience additional bleeding despite our best treatment efforts," said Dr. Lau, a physician at the Prince of Wales Hospital and professor at the Chinese University of Hong Kong. "However, our findings suggest a new approach with a powder that could ultimately prove to be more effective for patients and result in fewer complications."
A preliminary study on the safety of using a proprietary powder from Cook Medical, by Lau and colleagues, found it was beneficial in treating 95 per cent of patients with bleeding peptic ulcers. A peptic ulcer is an oval sore that develops when the lining of the stomach or duodenum is eaten away by stomach acid and digestive juices. First-line treatment involves the use of an endoscope, or a flexible tube, inserted through the mouth into the small intestine and stomach, to treat and repair bleeding ulcers. This is often done by injecting drugs into a blood vessel at the ulcer base or clipping or sealing the ulcer with a probe that generates heat.
In the study, researchers administered the powder through the channel of an endoscope. The powder was applied to the ulcer in one to two short bursts until bleeding stopped. They found the bleeding was successfully stopped in 95 per cent of cases and there was no recurrent bleeding or complications 30 days after treatment. The preliminary findings suggest the powder has high success rates and, most importantly, the technique of applying the powder is simple.
The findings signal future potential uses of the hemostatic powder to treat bleeding ulcers. Dr. Lau's findings is one of many innovative research studies being shared with colleagues around the world through an international conference at the Four Season Hotel in Toronto hosted by endoscopy experts at St. Michael's Hospital.
The Advanced Diagnostic and Therapeutic Endoscopy unit at St. Michael's is a center of excellence in therapeutic interventional and palliative endoscopy. Known worldwide as leaders in the field of endoscopy, physicians on the team have made groundbreaking discoveries and are performing some of the country's only and most innovative endoscopy techniques that allow for the early diagnosis and treatment of cancer.
St. Michael's Hospital provides compassionate care to all who walk through its doors. The Hospital also provides outstanding medical education to future health care professionals in more than 23 academic disciplines. Critical care and trauma, heart disease, neurosurgery, diabetes, cancer care, and care of the homeless are among the Hospital's recognized areas of expertise. Through the Keenan Research Centre and the Li Ka Shing Knowledge Institute, research at St. Michael's Hospital is recognized and put into practice around the world. Founded in 1892, the Hospital is fully affiliated with the University of Toronto.
Heart Surgery Transfusions - at best a waste of resources
"We don't know whether the variability is potentially harming patients," said lead author Elliott Bennett-Guerrero, M.D., director of Perioperative Clinical Research at Duke Clinical Research Institute and Professor of Anesthesiology/Critical Care. "Even if more liberal transfusion is not harmful to patients, it may represent a significant waste of scarce resources and money."
The researchers didn't find any link between patient mortality rates after surgery and whether the hospital was a high-transfusion site or a low-transfusion site, Bennett-Guerrero said.
The work was published in the Journal of the American Medical Association (JAMA) online on Oct. 12.
"To our knowledge there has never been a published large randomized trial in surgical patients looking at the impact of blood transfusion to determine whether we should be more restrictive or liberal with these transfusions," Bennett-Guerrero said. "Despite the fact that we spend billions of dollars on health care and research, we spend comparatively little on clinical effectiveness trials, which are gaining recognition as an informed way to change clinical practice."
Even when centers performing fewer operations were excluded, the researchers found that transfusion rates among the patients at hospitals ranged from 7.8 percent to 92.8 percent for red blood cells, 0 percent to 97.5 percent for fresh-frozen plasma, and 0.4 percent to 90.4 percent for platelets. The average cost of a unit of RBCs including direct and indirect costs was $761 in a 2010 study published in Transfusion journal.
The team, which included researchers from other institutions, found variation in RBC use based on geographic region, as well as higher RBC usage at academic hospitals and hospitals that performed the fewest number of coronary artery bypass graft (CABG) operations. Taken together, however, these three characteristics only accounted for 11.1 percent of variation in red-blood cell use.
The research team assessed data from the Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database kept by the Duke Clinical Research Institute, which captures clinical information from the majority of U.S. cardiac surgical procedures (up to 80 percent of all surgical data available).
The patients included in the study all had the same operation, a first-time, isolated coronary artery bypass graft (CABG), and all were on a heart-lung pump during surgery.
Differences in surgical techniques may help explain some of the variability. "There is a reasonable chance that some patients are getting transfused more because they are bleeding more during surgery, which could be linked to differences in surgical technique among the doctors," Bennett-Guerrero said.
Another likely difference is simply the transfusion culture at an institution. This may also have to do with early medical education and training, as some institutions pass along a pro-transfusion culture to those in training, he said.
argely circumstantial evidence suggests excessive blood transfusion for a patient may be harmful, Bennett Guerrero says. Everyone agrees that transfusion is needed when an injured person has lost most of their blood or has severe anemia. "It is difficult to get agreement, however, in situations where the patient has moderate blood loss or anemia," he said. "No one has yet proven that more liberal transfusion is harmful, and in the absence of results from high-quality randomized clinical studies, it is not surprising that there is variation in transfusion rates."
This work was supported by the Society of Thoracic Surgeons through the National Adult Cardiac Surgery Database and the Duke Clinical Research Institute.
Other authors include Yue Zhao and Sean M. O'Brien of the biostatistics division and Eric D. Peterson in the cardiology division of the Duke Clinical Research Institute; T.B. Ferguson of the Department of Cardiovascular Sciences, at the East Carolina Heart Institute, in Greenville, N.C.; James S. Gammie of the Division of Cardiac Surgery at the University of Maryland Medical Center in Baltimore; and senior author Howard K. Song of the Division of Cardiothoracic Surgery, Oregon Health and Science University in Portland.
Tuesday, October 12, 2010
Pfizer will buy King Pharmaceuticals for $3.6B
NEW YORK -- Pfizer Inc., the world's largest pharmaceutical company by revenue, said Tuesday it will buy pain drug makerKing Pharmaceuticals Inc. for $3.6 billion in cash.
Pfizer ( PFE - news - people ) is paying $14.25 per share for King. That's a premium of 40 percent to the stock's Monday closing price of $10.15. In the deal Pfizer gains products including the pain drug Avinza and EpiPen, a pre-filled injection designed to quickly treat serious allergic reactions.
The deal is Pfizer's largest since it bought rival Wyeth ( WYE - news -people ) for $68 billion in 2009. That deal closed last October.
King has struggled in recent years as patents on several of its key drugs have expired or been thrown out. But the Bristol, Tenn., company is heavily involved in developing pain drugs that are intended to be abuse-resistant. Abuse of pain drugs like oxycodone has become a major concern for health officials and regulators in recent years. The drugs are often crushed or dissolved to defeat their time-release mechanisms, allowing users to get high.
King's Embeda is one pain treatment that is designed to resist abuse attempts. King plans to file new applications for two similar drugs in the next few months, filing for approval of Remoxy in the fourth quarter of 2010 and Acurox in the first quarter of 2011. Remoxy and Embeda are extended-release drugs, while Acurox releases its painkilling ingredient immediately.
King's other products include the bleeding control drug Thrombin-JMI and the Flector pain patch.
Pfizer ( PFE - news - people ) is paying $14.25 per share for King. That's a premium of 40 percent to the stock's Monday closing price of $10.15. In the deal Pfizer gains products including the pain drug Avinza and EpiPen, a pre-filled injection designed to quickly treat serious allergic reactions.
The deal is Pfizer's largest since it bought rival Wyeth ( WYE - news -people ) for $68 billion in 2009. That deal closed last October.
King has struggled in recent years as patents on several of its key drugs have expired or been thrown out. But the Bristol, Tenn., company is heavily involved in developing pain drugs that are intended to be abuse-resistant. Abuse of pain drugs like oxycodone has become a major concern for health officials and regulators in recent years. The drugs are often crushed or dissolved to defeat their time-release mechanisms, allowing users to get high.
King's Embeda is one pain treatment that is designed to resist abuse attempts. King plans to file new applications for two similar drugs in the next few months, filing for approval of Remoxy in the fourth quarter of 2010 and Acurox in the first quarter of 2011. Remoxy and Embeda are extended-release drugs, while Acurox releases its painkilling ingredient immediately.
King's other products include the bleeding control drug Thrombin-JMI and the Flector pain patch.
Major medical devices maker invests €900,000 in R&D
A US$10bn supplier of healthcare products is to invest €900,000 with the National University of Ireland in two major R&D projects that will influence the future of surgery and wound healing.
Healthcare supply company Covidien has announced the €900,000 investment in medical technologies research and development projects with NUI Galway over the next two years, which is the first phase of a multi-part investment of €1.8m with Irish academic institutions announced by Covidien last July.
Covidien employs 2,000 people in Ireland and recently opened a 200-job European Services Centre in Cherrywood, Dublin. Some €11m has been invested in the state-of-the-art operation.
Covidien's chief technology officer Paul Hermes toldSiliconrepublic that innovation is at the heart of the company's efforts and that it holds more than 10,000 patents with a further 8,000 patents pending. “We have found Ireland to be the ideal environment for medical devices and healthcare research. From what we can tell, Ireland boasts the highest per capita presence of medical devices industries anywhere in the world.”
He said the company was focused on discovering "disruptive" technologies that will change the shape of healthcare for ever and that the company invests US$400m per annum in R&D.
Investment to aid patient health and safety
Minister for Health and Children Mary Harney TD described the investment as enabling the further development of patient health and safety through innovation and maintains it will yield high quality researchers.
“University-based facilities enabled by this collaboration with Covidien will help to ensure that Ireland continues to produce high-quality researchers who can innovate new technologies and design robust scientific research. This ultimately produces the valuable data that furthers patient health and safety,” she said.
Covidien hopes to incentivise students to choose science as a career and promote the continued growth and prosperity of the medical devices sector in Ireland.
“We believe the medical devices and health sectors will be a thriving part of Ireland’s business growth and high-technology job creation in the future,” said Scott Flora, president, surgical devices, Covidien.
Barry O’Leary, CEO, IDA Ireland, added: “Ireland is recognised as a key global hub for medical technologies, employing the highest medical technologies personnel per capita in Europe. Nearly 60pc of the sector’s companies are now carrying out R&D functions here ... industry and academia in Ireland can assist global companies such as Covidien to meet their R&D needs.”
NUI Galway's work
NUI Galway has investigated in situ forming biomaterial delivery systems that can be coupled with biologic factors. These materials may be delivered to soft tissue defects and can deploy growth factors and/or other biologics of interest to promote wound healing and tissue regeneration. The aim of the first project is to develop, characterise, and optimise the use of material systems containing microspheres for growth factor delivery and to develop assays to test the efficacy of these systems in promoting local wound healing.
NUI Galway also has significant experience with developing models to test the efficacy of novel compounds and medical devices. Covidien is interested in the design of specific, anatomically relevant models for products under development which can then be used for proof of concept, and generation of efficacy and regulatory data. The aim of the second project is to model conditions created during surgery and understand how product concepts perform under these conditions.
Healthcare supply company Covidien has announced the €900,000 investment in medical technologies research and development projects with NUI Galway over the next two years, which is the first phase of a multi-part investment of €1.8m with Irish academic institutions announced by Covidien last July.
Covidien employs 2,000 people in Ireland and recently opened a 200-job European Services Centre in Cherrywood, Dublin. Some €11m has been invested in the state-of-the-art operation.
Covidien's chief technology officer Paul Hermes toldSiliconrepublic that innovation is at the heart of the company's efforts and that it holds more than 10,000 patents with a further 8,000 patents pending. “We have found Ireland to be the ideal environment for medical devices and healthcare research. From what we can tell, Ireland boasts the highest per capita presence of medical devices industries anywhere in the world.”
He said the company was focused on discovering "disruptive" technologies that will change the shape of healthcare for ever and that the company invests US$400m per annum in R&D.
Investment to aid patient health and safety
Minister for Health and Children Mary Harney TD described the investment as enabling the further development of patient health and safety through innovation and maintains it will yield high quality researchers.
“University-based facilities enabled by this collaboration with Covidien will help to ensure that Ireland continues to produce high-quality researchers who can innovate new technologies and design robust scientific research. This ultimately produces the valuable data that furthers patient health and safety,” she said.
Covidien hopes to incentivise students to choose science as a career and promote the continued growth and prosperity of the medical devices sector in Ireland.
“We believe the medical devices and health sectors will be a thriving part of Ireland’s business growth and high-technology job creation in the future,” said Scott Flora, president, surgical devices, Covidien.
Barry O’Leary, CEO, IDA Ireland, added: “Ireland is recognised as a key global hub for medical technologies, employing the highest medical technologies personnel per capita in Europe. Nearly 60pc of the sector’s companies are now carrying out R&D functions here ... industry and academia in Ireland can assist global companies such as Covidien to meet their R&D needs.”
NUI Galway's work
NUI Galway has investigated in situ forming biomaterial delivery systems that can be coupled with biologic factors. These materials may be delivered to soft tissue defects and can deploy growth factors and/or other biologics of interest to promote wound healing and tissue regeneration. The aim of the first project is to develop, characterise, and optimise the use of material systems containing microspheres for growth factor delivery and to develop assays to test the efficacy of these systems in promoting local wound healing.
NUI Galway also has significant experience with developing models to test the efficacy of novel compounds and medical devices. Covidien is interested in the design of specific, anatomically relevant models for products under development which can then be used for proof of concept, and generation of efficacy and regulatory data. The aim of the second project is to model conditions created during surgery and understand how product concepts perform under these conditions.
Saturday, October 9, 2010
German Company Biocer, Advances Plant Based Hemostatic Powder Technologies
BioCer Entwicklungs GmbH is a young and innovative company. Now on the basis of its comprehensive knowledge our developer team succeeded to provide health care with two seminal products according to the model of the nature.
With the help of a nanotechnological surface coating, implant materials are modified in a way that the medical devices grow in faster and more optimized. These biocom-patible coatings are now applied for the first time to polymer meshes, which are used as soft tissue reinforcement for hernia repair. In cooperation with experts from the textile branch BioCer Entwicklungs GmbH managed to develop a medical device which fulfills together with its optimized surface all demands of a modern mesh im-plant.
Also the development of our innovative hemostatic powder HaemoCer® was per-formed according to nature. HaemoCer® consists of plant based particles with an extremely high hygroscopicity, so that the natural coagulation cascade is accelerated. Hemostasis occurs within short time and HaemoCer® will be completely absorbed from the body within a few days.
With its new products BioCer Entwicklungs GmbH supports the surgeon as well as the patient in healing and restoration of the health.
Click Thumbnail Below for Presentation (note this presentation has been updated at the companies request)
BIOCER ENTWICKLUNGS-GMBH
Ludwig-Thoma Straße 36c
95447 Bayreuth
Telefone: +49 (0) 921 78 77 70 0
Telefax: +49 (0) 921 78 77 70 79
info@biocer-gmbh.de
With the help of a nanotechnological surface coating, implant materials are modified in a way that the medical devices grow in faster and more optimized. These biocom-patible coatings are now applied for the first time to polymer meshes, which are used as soft tissue reinforcement for hernia repair. In cooperation with experts from the textile branch BioCer Entwicklungs GmbH managed to develop a medical device which fulfills together with its optimized surface all demands of a modern mesh im-plant.
Also the development of our innovative hemostatic powder HaemoCer® was per-formed according to nature. HaemoCer® consists of plant based particles with an extremely high hygroscopicity, so that the natural coagulation cascade is accelerated. Hemostasis occurs within short time and HaemoCer® will be completely absorbed from the body within a few days.
With its new products BioCer Entwicklungs GmbH supports the surgeon as well as the patient in healing and restoration of the health.
Click Thumbnail Below for Presentation (note this presentation has been updated at the companies request)
BIOCER ENTWICKLUNGS-GMBH
Ludwig-Thoma Straße 36c
95447 Bayreuth
Telefone: +49 (0) 921 78 77 70 0
Telefax: +49 (0) 921 78 77 70 79
info@biocer-gmbh.de
Friday, October 8, 2010
Arterial Closure Device Recommendations
The number and quality of clinical studies on arterial closure devices for cardiovascular procedures limits their widespread use, but new recommendations issued by the American Heart Association are intended to aid cardiologists considering use of these technologies. The recommendations were published online Oct. 4 in Circulation.
(HealthDay News) — The number and quality of clinical studies on arterial closure devices (ACDs) for cardiovascular procedures limits their widespread use, but new recommendations issued by the American Heart Association are intended to aid cardiologists considering use of these technologies. The recommendations were published online Oct. 4 in Circulation.
Manesh R. Patel, M.D., chair of the American Heart Association writing committee issuing the statement, and colleagues summarized the current state of vascular access, including patient risks, the evidence for use of various ACDs, and recommendations for their use. Seven million invasive cardiovascular procedures are performed each year, with numbers expected to increase in the future, and vascular access complications may be as high as 6 percent, the authors write.
After an extensive literature review of both passive and active closure devices, the committee issued five recommendations regarding ACD use. According to the recommendations, patients considered for use of femoral ACDs should undergo a femoral angiogram to ensure anatomic suitability for their use; facilities using manual compression should aim to achieve low vascular complication rates (below 1 percent); ACDs should not be used routinely, but can reasonably be used for faster hemostasis, and possibly improved patient comfort, as long as risks are weighed against benefits; and data on complications should be systematically collected via registry and reported to the U.S. Food and Drug Administration. Click Thumbnail below to view.
(HealthDay News) — The number and quality of clinical studies on arterial closure devices (ACDs) for cardiovascular procedures limits their widespread use, but new recommendations issued by the American Heart Association are intended to aid cardiologists considering use of these technologies. The recommendations were published online Oct. 4 in Circulation.
Manesh R. Patel, M.D., chair of the American Heart Association writing committee issuing the statement, and colleagues summarized the current state of vascular access, including patient risks, the evidence for use of various ACDs, and recommendations for their use. Seven million invasive cardiovascular procedures are performed each year, with numbers expected to increase in the future, and vascular access complications may be as high as 6 percent, the authors write.
After an extensive literature review of both passive and active closure devices, the committee issued five recommendations regarding ACD use. According to the recommendations, patients considered for use of femoral ACDs should undergo a femoral angiogram to ensure anatomic suitability for their use; facilities using manual compression should aim to achieve low vascular complication rates (below 1 percent); ACDs should not be used routinely, but can reasonably be used for faster hemostasis, and possibly improved patient comfort, as long as risks are weighed against benefits; and data on complications should be systematically collected via registry and reported to the U.S. Food and Drug Administration. Click Thumbnail below to view.
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