Vascular graft developer Somahlution said today it launched the DuraGraft European Registry clinical trial of its DuraGraft device, enrolling the 1st patient in the study.
In the registry study, investigators will evaluate the Jupiter, Fla.-based company’s DuraGraft, a vascular graft treatment designed to reduce the burden of ischemia reperfusion injuries, during use in coronary artery bypass grafting procedures.
The 1st patient was enrolled at Germany’s Helios Hospital Wuppertal, with enrollment also beginning at the Helios Heart Center Leipzig. The 1st patient was treated by Dr. Herbert Vetter, Somahlution said.
“Initiation of the DuraGraft Registry marks an important milestone in the future of CABG surgery. Vein grafts have remained a concern, however we are now hopeful that DuraGraft will provide a new treatment option to better treat these conduits,” Dr. Martin Misfeld, of the Helios Heart Center Leipzig said in a prepared statement.
The study will evaluate patients undergoing CABG only or CABG plus valve surgeries, with baseline clinical and angiographic characteristics as well as certain post-op clinical events being recorded, the company said. Outcomes will be assessed through hospitalization, at 30 days and annually for up to 5 years.
The DuraGraft is based on the GALA technology platform licensed by Somahlution from the US Dept. of Veterans Affairs, the company said, and is a vascular graft treatment designed to maintain structural and functional integrity of the vascular graft.
“DuraGraft provides a novel treatment option to improve graft patency and improve cardiac bypass surgery outcomes. We are thrilled to be the first center in Germany to enroll patients and utilize new technologies like DuraGraft to improve CABG surgery and patient outcomes,” lead investigator Dr. Vetter said in a press release.
