JUPITER, Fla., Jan. 4, 2017 -- Somahlution, a global biotechnology company developing products to reduce the burden of ischemia reperfusion injury in tissue grafting, organ transplant and other surgical indications, today announced enrollment of the first subject in their DuraGraft® CABG European Registry. The registry will evaluate the company's flagship product DuraGraft, a vascular graft treatment that significantly improves long-term clinical outcomes following Coronary Artery Bypass Grafting (CABG) surgery. The Registry will include 3,000 subjects from 50+ European sites across 10 countries.
The first enrolled subject was treated at Galway University Hospital, Galway, Ireland. "DuraGraft offers the opportunity to maximize graft patency following CABG especially for saphenous vein grafts and hence minimize the incidence of complications associated with graft failures which include myocardial infarction and repeat revascularization," said the site's Principal Investigator Dr. Dave Veerasingam MD, Cardiac Surgeon.
Subjects undergoing CABG only or CABG plus Valve surgery will be consented to participate in this Registry. For these patients, baseline clinical and angiographic characteristics, as well as certain procedural and post-op clinical events will be recorded. Clinical outcomes will be assessed post CABG through hospitalization, at 30 days, and annually up to 5 years.
"In addition to capturing clinical outcomes, the Registry will capture additional safety data and other important health economic and quality of life data. We believe, physicians will be eager to participate based on DuraGraft's robust clinical history," according to Dr. Maximillian Emmert of University of Zurich, Registry Lead Principal Investigator.
DuraGraft is the first commercial product based on the GALA technology platform licensed by Somahlution from the U.S. Department of Veterans Affairs. DuraGraft is a vascular graft treatment that improves clinical outcomes by reducing the incidence of complications of graft failure. DuraGraft treatment was launched in Europe and other global markets in 2015 for CABG and peripheral bypass indications, and is not yet commercially available in the U.S.
Somahlution is a global leader in the development of products to reduce the burden of ischemia reperfusion injury in tissue grafting, organ transplant and other surgical indications. The company's flagship product, DuraGraft, is a vascular graft treatment that improves clinical outcomes by reducing the incidence of complications of graft failure. DuraGraft enhances CABG outcomes by significantly reducing major cardiac events such as repeat revascularization and myocardial infarction.
For more information about the company, please visit www.somahlution.com.
Back to the latest news