Sunday, November 16, 2014

Comparison of methods to achieve artery closure following coronary angiography

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."

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.

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.

Wednesday, October 8, 2014

HaemoCer approved for use in China and Canada

BioCer Entwicklungs GmbH (BCE), a German implantable biological medical device development and manufacturing company, announced today that it has achieved approval to commence sales of HaemoCer™, an Absorbable Polysaccharide Hemostat (APH), in the People's Republic of China.
"BioCer has now achieved near comprehensive Asia-Pacific regional representation, and the addition of the PRC approval of HaemoCer™ is a significant milestone," Dr Markus Heinlein, Managing Director stated. "The entry into China of our first product HaemoCer™ has been assisted by the early establishment of regional sales representation in the Asia-Pacific region. BCE are pleased Chinese surgeons and patients will now share the benefits of our technology. Our new Health Canada approval is also further evidence of strong international acceptance of our technology."
The PRC approval of HaemoCer™ expands an international sales network encompassing AustraliaHong KongIndia, Korea,MalaysiaNew ZealandSingapore and Thailand within the APEC region. BCE will be exhibiting at the EACTS, Milan, Italy, 11-15thOctober and the CMEF, Chongqing, China, 23-26th October 2014

Tuesday, August 19, 2014

Cardiva Medical, Inc. Announces Completion of the first two tranches of Series 3 Private Equity Financing and the Closing of a Senior Secured Debt Facility with GE Capital

SUNNYVALE, Calif.Aug. 19, 2014 /PRNewswire/ -- Cardiva Medical, Inc. announced today that it has closed the first two tranches of a$16.5 million Series 3 private equity financing and a $12.5 million senior secured facility with GE Capital. The Company will use the proceeds of the Series 3 private equity financing and debt facility to expand commercial efforts for its VASCADE® Vascular Closure System in the United States.
Investing in Series 3 private equity financing was a new investor, Canepa Advanced Healthcare Fund, L.P., who joined existing investors PTV Sciences, AmKey Ventures and TriVentures II Fund L.P.  Mr. Paul Enever from Canepa U.S., LLC, which serves as Investment Advisor to Canepa Advanced Healthcare Fund, L.P., has joined the Cardiva Board of Directors.
"We are extremely pleased that Canepa Advanced Healthcare, L.P. has joined Cardiva's current investors in this financing and that Paul Enever has joined our Board of Directors," said Charles Maroney, CEO. Maroney continued, "With the Series 3 equity financing and GE debt facility, Cardiva now has the financial resources to establish VASCADE as a leading extravascular closure technology which we believe can benefit both patients and healthcare providers in the United States by minimizing complications and associated costs and improving patient care when compared to conventional vascular closure devices."
"Cardiva's product platform offers the potential to transform the vascular closure market by improving both patient safety and comfort", said Paul Enever of Canepa U.S., LLC. Enever continued, "VASCADE leverages Cardiva's Catalyst® platform that has been utilized effectively in more than 400,000 procedures since its initial launch into the U.S. market in 2007". We are delighted to add Cardiva to our investment portfolio of emerging growth medical device companies that are focused on improving patient outcomes while reducing the cost of medical care."

Tuesday, August 5, 2014

Transluminal Tech’s velox CD Arterial Closure Device Gets EU Approval

velox CD Transluminal Techs velox CD Arterial Closure Device Gets EU Approval (VIDEO)
squeeze velox CD Transluminal Techs velox CD Arterial Closure Device Gets EU Approval (VIDEO)Transluminal Technologies LLC. out of Syracuse, New York won the CE Mark for its velox CD Vascular Closure Device used to close arteriotomies following percutaneous femoral procedures. Closing arteries can be a challenge, eating up surgeons’ time just when it’s optimal to move the patient out of the OR. The velox CD device speeds up this process by delivering an implant that plugs the vessel wall from within.
The implant consists of an intraluminal footplate that absorbs within about 24 hours and a extraluminal plug that takes two weeks to absorb. The components are made of a proprietary magnesium alloy that breaks up and bioabsorbs safely into the body, leaving a clean repaired artery without the surgeon having to manually apply pressure during closure.
Here’s a video from a real procedure utilizing the velox CD:

Monday, June 30, 2014

Clot-building nanoparticles raise survival rate following blast trauma Read more: Clot-building nanoparticles raise survival rate following blast trauma

A type of artificial platelet being developed to help natural blood platelets form clots faster offers promise for saving the lives of soldiers, as well as victims of car crashes and other severe trauma.
In preclinical tests led by a Case Western Reserve University researcher, the artificial platelets, called "hemostatic nanoparticles," when injected after blast trauma dramatically increased survival rates and showed no signs of interfering with healing or causing other complications weeks afterward.
"The nanoparticles have a huge impact on survival—not just in the short term, but in the long term," said Erin Lavik, an associate professor of biomedical engineering at Case Western Reserve. Other researchers had raised concerns that the foreign matter would interfere with healing, or form free-floating clots, but "we saw none of that."
The research, published in the Proceedings of the National Academy of Sciences this week ("Intravenously administered nanoparticles increase survival following blast trauma"), show the survival rate of mice models of blast trauma treated with the nanoparticles increased to 95, compared to 60 percent for those untreated.
Hemostatic Nanoparticles
Spherical hemostatic nanoparticles accumulate on a clot-stabilizing mesh of fibrin the body produces. (Image: Andrew Shoffstall)
Also, no unwanted side effects, such as accumulation of the nanoparticles, clot formation or aberrant healing, were found during examinations one ands three weeks after the injection.
Lavik worked with Margaret M. Lashof-Sullivan, Erin Shoffstall and Kristyn T. Atkins, of Case Western Reserve; Nickolas Keane and Cynthia Bir of Wayne State University and Pamela VandeVord of Virginia Tech.
Explosions account for 79 percent of combat-related injuries and are the leading cause of battlefield deaths, according to researchers at Veterans Affairs hospitals and the federally run Uniformed Services University of the Health Sciences.
The primary blast wave, flying shrapnel and being thrown to the ground cause the lungs, liver, kidneys and other organs to hemorrhage and bleed uncontrollably.
Such uncontrolled bleeding from collisions, blows and falls is also the leading cause of death among victims age 5 to 44 in the United States.
Natural blood platelets are the key ingredient to stopping bleeding, a process called hemostasis. The process works well for typical cuts and scrapes, but can be overwhelmed with serious injuries.
a schematic of hemostatic nanoparticles linking with blood platelets
This is a schematic of hemostatic nanoparticles linking with blood platelets. The nanoparticles significantly increased survival rate from blast trauma in preclinical testing. (Image: Erin Lavik)
Hospitals try to stem internal bleeding by giving trauma patients blood products or the hemophilia medicine called recombinant factor VIIa, but there isn't a good option for the battlefield or accident scenes. Recombinant factor VIIa must be refrigerated, costs up to tens of thousands of dollars per treatment and can cause clots in brain and spinal cord injuries, which are common from explosions.
Lavik's team has fine-tuned the nanoparticles to increase clotting efficiency. "They are incredibly simple… spheres with arms of peptides that react with activated blood platelets in damaged tissues to help clots form more quickly," she said.
The particles are made from short polymer chains already approved for other uses by the U.S. Food and Drug Administration. In earlier testing, rat models injected with the nanoparticles stopped bleeding faster than untreated models.
The dry particles remained viable after two weeks on a shelf. A medic in the field or an ambulance crew would add saline, shake and inject them, the researchers say.
Further research and testing are underway. Clinical trials on humans are likely at least five years out, Lavik said.

Tuesday, June 3, 2014

A device to control bleeding in brain surgery receives Phase 2 SBIR grant


EndomedixA medical device developer got a big boost in its efforts to develop a surgical sealant for brain surgery. Endomedix received a $1.49 million Phase 2 Small Business Innovation Research grant to help control bleeding for surgical procedures, according to a company statement. It received the grant from the National Institute of Neurological Disorders and Stroke.


The funding will go toward safety studies, in vivo performance studies and developing an applicator device. The sealant is a hydrogel that includes two processed biocompatible polysaccharides. They are simultaneously mixed and sprayed onto a surgical site.

Typically, a Phase 2 SBIR grant doesn’t exceed $1 million over a two-year period.

The market value for sealants and related devices is expected to top $4.2 billion in 2018. But some factors that could impact the size of the market include the efforts to limit expensive hospital admissions, shift procedures to outpatient settings and reduce rates of re-admissions.

Endomedix has won six SBIR Phase I grants totaling more than $1.1 million to advance its sealants program.

The Newark medical device company is based at the Enterprise Development Center incubator at the New Jersey Institute of Technology.

Sunday, May 18, 2014

Cohera Medical, Inc.® Files for CE Mark Approval for Sylys® Surgical Sealant

PITTSBURGHMay 15, 2014 /PRNewswire/ -- Cohera Medical, Inc.®, a leading innovator and developer of absorbable surgical adhesives and sealants, announced today that it has applied for CE Mark approval for Sylys® Surgical Sealant, the first synthetic sealant designed specifically to help reduce anastomotic leaks in gastrointestinal procedures.  CE Mark approval, expected by the end of 2014 based on this filing, will allow for marketing of the product in the European Union and other countries.
Sylys is applied during gastrointestinal procedures to help prevent the occurrence of anastomotic leaks – a serious complication that occurs in up to 23 percent of patients undergoing colorectal surgery. At least one-third of the post-surgical mortality after colorectal surgery is attributed to leaks, and survivors generally have protracted recoveries. The additional care required to manage this serious complication can cause up to a five-fold increase in patient management costs.
"Anastomotic leakage is the most devastating complication associated with intestinal resection, contributing to morbidity and mortality," said James McCormick, DO, FACS, FASCRS, Chief, Division of Colorectal Surgery, The Western Pennsylvania Hospital. "We have made tremendous strides in curtailing the risk associated with intestinal anastomosis, but we are always striving for further improvement and greater patient safety."
Sylys is designed to help reduce anastomotic leakage in intestinal procedures by providing additional support during the first few days of healing, when the development of leaks is most likely to occur.  The sealant is applied as a viscous fluid that cures rapidly to create a flexible, elastic seal over the anastomosis site.
"The preparation and filing of the CE Mark application for Sylys, a Class III implant technology, represents a significant milestone and achievement by all of the employees of Cohera Medical," said Chad A. Coberly, JD, Vice President of Clinical, Regulatory and Legal Affairs for Cohera Medical. "The submission signifies that we have completed the rigorous clinical and pre-clinical testing, quality, and performance requirements of the EU authorities, and we look forward to working with our notified body during the approval process."
The market for Sylys is significant, with several hundred thousand procedures a year worldwide representing a multi-billion dollar opportunity. Due to the unmet clinical need, Sylys would represent a breakthrough in this market that will lead to improved patient outcomes as well as reduced patient management costs for healthcare providers.
"Submitting the Sylys CE Mark application represents a significant milestone towards the commercialization of our second product and demonstrates the commitment we have to our future customers, partners, and investors," said Patrick Daly, Cohera Medical president and CEO. "We look forward to making Sylys available to surgeons and patients throughout the world."