Stefanie Schulz-Schupke, M.D., of the Deutsches Herzzentrum Munchen, Technische Universitat, Munich, Germany and colleagues assessed whether vascular closure devices are noninferior (not worse than) to manual compression in terms of access site-related vascular complications in patients undergoing diagnostic coronary angiography. The study appears in the November 19 issue of JAMA, a cardiovascular disease theme issue.
Percutaneous (through the skin) coronary angiography and interventions have become a cornerstone in the diagnosis and treatment of coronary artery disease. A substantial proportion of the adverse effects associated with these procedures is related to access-site complications. The common femoral artery (a large artery in the groin) is still the most frequently used access site. After the procedure, closure of the artery access site is usually achieved by manual compression. Since the mid-1990s, however, vascular closure devices (VCDs) have been introduced into clinical practice with the aim of improving efficacy and safety. Different types of VCDs have been developed, including intravascular and extravascular. However, concern exists about the safety of VCDs in comparison with manual compression, according to background information in the article.
For this study, conducted at four centers in Germany, 4,524 patients undergoing coronary angiography via the common femoral artery were randomly assigned to receive an intravascular VCD (n = 1,509), extravascular VCD (n = 1,506), or manual compression (n = 1,509) to achieve hemostasis (defined as no bleeding or only light superficial bleeding and no expanding hematoma [a localized swelling filled with blood]). Before hospital discharge, imaging of the access site was performed in 4,231 (94 percent) patients.
The primary end point (the composite of access site-related vascular complications at 30 days after randomization with a two percent noninferiority margin) was observed in 208 patients (6.9 percent) assigned to receive a VCD and 119 patients (7.9 percent) assigned to manual compression (difference, -1.0 percent). In addition, the time to hemostasis was significantly shorter with VCD compared with manual compression; time to hemostasis was shorter with intravascular VCD vs extravascular VCD; and device failures were less frequent with intravascular VCD vs extravascular VCD.
The authors write that the results of this trial may represent an important development for the clinical use of these devices. "Overall, the increase in efficacy of VCD use, with no trade-off in safety, provides a sound rationale for the use of VCD over manual compression in daily routine."
Sunday, November 16, 2014
Start-up pitches high-tech glue for surgical leaks
TEL AVIV — An Israeli medical-device start-up is tackling one of the most dangerous occurrences in surgery — and it's doing it with glue.
LifeSeal is a glue-like substance that augments and, in some surgeries like hernias, replaces the traditional and painful sealing procedures of staples, tacks and sutures.
The privately-owned Israeli company behind the high-tech glue, LifeBond, says it should help in the treatment of post-operative leaks in closures of gastrointestinal and other surgical wounds. Patients get back up to speed more quickly and are more comfortable as they do.
Orahn Preiss-Bloom, one of LifeBond's co-founders, says the company's proprietary materials, which combine gelatin and an enzyme and are delivered by an applicator, were inspired by two sources: research by Professor Gregory Payne at the University of Maryland and the use of the enzyme for food applications in Asia.
The company is backed by some of Israel's top venture-capital firms as well as by Robert Taub, a prominent medical-innovation investor. And the idea is strong enough that Johnson & Johnson (TICKER: JNJ), the New Jersey-based international health-care giant, has put money down on LifeBond.
The technology is currently in European clinical trials. And with an eye to entering the U.S. market as well, CEO Gideon Sturlesi and Preiss-Bloom are looking for partners and raising capital.
TWO CURRENT APPLICATIONS
Started in 2007 and employing 35 people from headquarters in Caesarea, Israel, LifeBond for now is focusing the technology's application on gastrointestinal surgery and bariatric weight-loss procedures as well as in hernia surgery.
Colon-cancer surgeries require what the doctors call anastomosis, removal of diseased intestine and reattachment to restore the gastronintestinal tract's functionality. The further down in the colon a surgeon must work, the higher the risk that a seal will leak, Sturlesi says. In some 15% to 25% of lower-colon operations, the seals leak, exposing the patients to infection and additional surgery, even death.
In such procedures, after a surgeon applies staples to close the colon, he or she spreads LifeSeal – using a glue-like applicator – along the line of the closure. The sealant provides a secure and elastic barrier to infection while the body heals. Tissue grows in and the sealant gradually dissipates.
LifeBond's second current major application, which the company calls LifeMesh, targets another very common surgery: hernias, the breaks in people's abdominal walls.
To secure a protruding intestine back into the abdomen, surgeons usually tack a mesh into place to close the break. These tacks cause inflammation and pain.
Here, the same proprietary material used in LifeSeal becomes an adhesive. In both open hernia surgery and procedures with a laparascope, the surgeon coats a standard mesh patch with LifeSeal and places it to secure the abdominal wall. The surgeon can reposition the mesh if and when necessary. LifeBond says the product keeps the patch in place as the body's tissues grow in and then dissipates.
LifeBond's two co-founders are Preiss-Bloom, 32, a New Yorker who is chief technology officer; and Ishay Attar, 42, who was vice president of business development at what is now Trendlines Medical, a tech-firm incubator. Both have master's degrees in biomedical engineering from the Technion, the Israel Institute of Technology. Attar remains a shareholder but doesn't hold a position with LifeBond.
CEO Sturlesi, 53, joined the company two years ago. Previously he was executive vice president at Lumenis, the producer of laser equipment for medical and cosmetic applications, and he was a co-founder of Galil Medical, a producer of cryosurgical technology. LifeBond's chairman is Ittai Harel, general partner of Pitango, a Herzliya, Israel, venture-capital firm and investor in LifeBond.
Worldwide market: $450 mln
LifeBond's first two target markets are substantial. The company estimates that annually in the U.S., 300,000 colorectal anastomosis procedures are done each year. The company pegs the worldwide market for this application at $450 million, a third of it in the U.S. And LifeBond says 2 million hernia repairs are done annually worldwide, half of them in the U.S. That's overall also a $450 million market.
LifeBond's investors include the Israeli venture-capital firms Aurum, Giza and Pitango. Also an investor, and a director, is Robert Taub, who founded Omrix, a producer of sealant used to control bleeding during surgery. J&J acquired Omrix in 2007.
In 2011, when LifeBond raised $20 million in a third-round financing, the New Brunswick, N.J., health-care giant J&J joined the round. Its specific investment hasn't been disclosed. LifeBond previously raised $1.5 million and $8.5 million in its Series A and Series B rounds respectively.
LifeBond is now in a Series D round, aiming to raise a total of $25 million by early 2015, and current investors have committed about half that figure.
In first-half 2013, LifeBond did a first clinical study in Sweden to test the application method for LifeSeal and to evaluate the product for safety. That study met its goals and this year LifeBond enrolled patients in a second study at eight centers in Belgium, Israel and Sweden. The company is expecting the results of that trial in November. The study's goal is to receive the CE Mark, which means that the product meets EU standards.
Sturlesi says the company has started the U.S. Food and Drug Administration process to develop the studies it needs to gain clearance to market LifeSeal in the U.S.
The company sees additional applications for LifeBond's system in surgeries involving the eye, brain, lungs, spine, urological system, and ear, nose and throat.
"We are there to support the natural healing process of the body," Sturlesi says.
LifeSeal is a glue-like substance that augments and, in some surgeries like hernias, replaces the traditional and painful sealing procedures of staples, tacks and sutures.
The privately-owned Israeli company behind the high-tech glue, LifeBond, says it should help in the treatment of post-operative leaks in closures of gastrointestinal and other surgical wounds. Patients get back up to speed more quickly and are more comfortable as they do.
Orahn Preiss-Bloom, one of LifeBond's co-founders, says the company's proprietary materials, which combine gelatin and an enzyme and are delivered by an applicator, were inspired by two sources: research by Professor Gregory Payne at the University of Maryland and the use of the enzyme for food applications in Asia.
The company is backed by some of Israel's top venture-capital firms as well as by Robert Taub, a prominent medical-innovation investor. And the idea is strong enough that Johnson & Johnson (TICKER: JNJ), the New Jersey-based international health-care giant, has put money down on LifeBond.
The technology is currently in European clinical trials. And with an eye to entering the U.S. market as well, CEO Gideon Sturlesi and Preiss-Bloom are looking for partners and raising capital.
TWO CURRENT APPLICATIONS
Started in 2007 and employing 35 people from headquarters in Caesarea, Israel, LifeBond for now is focusing the technology's application on gastrointestinal surgery and bariatric weight-loss procedures as well as in hernia surgery.
Colon-cancer surgeries require what the doctors call anastomosis, removal of diseased intestine and reattachment to restore the gastronintestinal tract's functionality. The further down in the colon a surgeon must work, the higher the risk that a seal will leak, Sturlesi says. In some 15% to 25% of lower-colon operations, the seals leak, exposing the patients to infection and additional surgery, even death.
In such procedures, after a surgeon applies staples to close the colon, he or she spreads LifeSeal – using a glue-like applicator – along the line of the closure. The sealant provides a secure and elastic barrier to infection while the body heals. Tissue grows in and the sealant gradually dissipates.
LifeBond's second current major application, which the company calls LifeMesh, targets another very common surgery: hernias, the breaks in people's abdominal walls.
To secure a protruding intestine back into the abdomen, surgeons usually tack a mesh into place to close the break. These tacks cause inflammation and pain.
Here, the same proprietary material used in LifeSeal becomes an adhesive. In both open hernia surgery and procedures with a laparascope, the surgeon coats a standard mesh patch with LifeSeal and places it to secure the abdominal wall. The surgeon can reposition the mesh if and when necessary. LifeBond says the product keeps the patch in place as the body's tissues grow in and then dissipates.
LifeBond's two co-founders are Preiss-Bloom, 32, a New Yorker who is chief technology officer; and Ishay Attar, 42, who was vice president of business development at what is now Trendlines Medical, a tech-firm incubator. Both have master's degrees in biomedical engineering from the Technion, the Israel Institute of Technology. Attar remains a shareholder but doesn't hold a position with LifeBond.
CEO Sturlesi, 53, joined the company two years ago. Previously he was executive vice president at Lumenis, the producer of laser equipment for medical and cosmetic applications, and he was a co-founder of Galil Medical, a producer of cryosurgical technology. LifeBond's chairman is Ittai Harel, general partner of Pitango, a Herzliya, Israel, venture-capital firm and investor in LifeBond.
Worldwide market: $450 mln
LifeBond's first two target markets are substantial. The company estimates that annually in the U.S., 300,000 colorectal anastomosis procedures are done each year. The company pegs the worldwide market for this application at $450 million, a third of it in the U.S. And LifeBond says 2 million hernia repairs are done annually worldwide, half of them in the U.S. That's overall also a $450 million market.
LifeBond's investors include the Israeli venture-capital firms Aurum, Giza and Pitango. Also an investor, and a director, is Robert Taub, who founded Omrix, a producer of sealant used to control bleeding during surgery. J&J acquired Omrix in 2007.
In 2011, when LifeBond raised $20 million in a third-round financing, the New Brunswick, N.J., health-care giant J&J joined the round. Its specific investment hasn't been disclosed. LifeBond previously raised $1.5 million and $8.5 million in its Series A and Series B rounds respectively.
LifeBond is now in a Series D round, aiming to raise a total of $25 million by early 2015, and current investors have committed about half that figure.
In first-half 2013, LifeBond did a first clinical study in Sweden to test the application method for LifeSeal and to evaluate the product for safety. That study met its goals and this year LifeBond enrolled patients in a second study at eight centers in Belgium, Israel and Sweden. The company is expecting the results of that trial in November. The study's goal is to receive the CE Mark, which means that the product meets EU standards.
Sturlesi says the company has started the U.S. Food and Drug Administration process to develop the studies it needs to gain clearance to market LifeSeal in the U.S.
The company sees additional applications for LifeBond's system in surgeries involving the eye, brain, lungs, spine, urological system, and ear, nose and throat.
"We are there to support the natural healing process of the body," Sturlesi says.
Synthetic platelets helps clot blood faster
New York: Taking a cue from the human body’s own blood-clotting process, researchers at University of California, Santa Barbara have developed synthetic platelets that can do more than clot blood.
By creating nanoparticles that mimic the shape, flexibility and surface biology of the body’s own platelets, the team was able to accelerate natural healing processes while opening the door to therapies and treatments that can be customised to specific patient needs.
“This is a significant milestone in the development of synthetic platelets, as well as in targeted drug delivery,” said Samir Mitragotri, director of Center for Bioengineering (CBE) who specialises in targeted therapy technologies.
In case of blood loss due to minor injury, platelets release chemicals that “call” other platelets to the site, eventually plugging the wound.
But what happens when the injury is too severe or the patient is on anti-coagulation medication or is otherwise impaired in his or her ability to form a clot, even for a modest or minor injury?
That’s where platelet-like nanoparticles (PLNs) come in.
“These tiny, platelet-shaped particles that behave just like their human counterparts can be added to the blood flow to supply or augment the patient’s own natural platelet supply, stemming the flow of blood and initiating the healing process,” researchers emphasised.
“We were actually able to render a 65 percent decrease in bleeding time compared to no treatment,” said graduate student researcher Aaron Anselmo, lead author of the study.
With PLNs, emergency situations can be brought under control faster, injuries can heal more quickly and patients can recover with fewer complications, he added.
The results appeared in the journal ACS Nano.
By creating nanoparticles that mimic the shape, flexibility and surface biology of the body’s own platelets, the team was able to accelerate natural healing processes while opening the door to therapies and treatments that can be customised to specific patient needs.
“This is a significant milestone in the development of synthetic platelets, as well as in targeted drug delivery,” said Samir Mitragotri, director of Center for Bioengineering (CBE) who specialises in targeted therapy technologies.
In case of blood loss due to minor injury, platelets release chemicals that “call” other platelets to the site, eventually plugging the wound.
But what happens when the injury is too severe or the patient is on anti-coagulation medication or is otherwise impaired in his or her ability to form a clot, even for a modest or minor injury?
That’s where platelet-like nanoparticles (PLNs) come in.
“These tiny, platelet-shaped particles that behave just like their human counterparts can be added to the blood flow to supply or augment the patient’s own natural platelet supply, stemming the flow of blood and initiating the healing process,” researchers emphasised.
“We were actually able to render a 65 percent decrease in bleeding time compared to no treatment,” said graduate student researcher Aaron Anselmo, lead author of the study.
With PLNs, emergency situations can be brought under control faster, injuries can heal more quickly and patients can recover with fewer complications, he added.
The results appeared in the journal ACS Nano.
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