Published 02 February 2017
Somahlution has announced that multiple sites in Spain have begun enrolling patients in the 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 first patient enrolled in Spain was treated at Hospital De Cruces Barakaldo, Bilbao. “We are looking forward to participating in the DuraGraft registry. Any opportunity to improve graft patency must be studied and considered so that we may improve long-term outcomes for CABG patients,” said the site’s Principal Investigator Dr. José Ignacio Aramendi Gallardo, Cardiac Surgeon.
In addition to Hospital De Cruces Barakaldo, Bilbao, Hospital Ramon y Cajal and Hospital Gregorio Marañon (both in Madrid) and Complejo Hospitalario Universitario de Santiago de Compostela have enrolled patients in the Spanish registry.
Patients 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.
“Real world evidence is of upmost value to clinicians; the Spain healthcare market will be a large contributor to our European Registry. While our 2,400 patient US retrospective study has already provided convincing real world evidence supporting the clinical benefit of DuraGraft, we anticipate our European registry will complement and support these findings.” Tracy Goeken, MD, Somahlution Vice President and Chief Medical Officer.
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 is CE Marked in Europe and available in other global markets for CABG and peripheral bypass indications, and is not yet commercially available in the U.S.
Source: Company Press Release