Somahlution has announced enrolment of the first patient in its DuraGraft coronary artery bypass grafting (CABG) European Registry. The registry will evaluate DuraGraft—a vascular graft treatment that, according to a press release, significantly improves long-term clinical outcomes following CABG. The registry will include 3,000 patients from 50 plus European sites across 10 countries. The first enrolled patient was treated at Galway University Hospital, Galway, Ireland.
Patients undergoing CABG only or CABG plus valve surgery will be consented to participate in the 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 hospitalisation, at 30 days, and annually up to five years. Galway University Hospital’s principal investigator Dave Veerasingam comments: “DuraGraft offers the opportunity to maximise graft patency following CABG especially for saphenous vein grafts and hence minimise the incidence of complications associated with graft failures which include myocardial infarction and repeat revascularisation.”
The press release reports that DuraGraft is the first commercial product based on the GALA technology platform licensed by Somahlution from the US Department of Veterans Affairs. The product is a vascular graft treatment that improves clinical outcomes by reducing the incidence of complications of graft failure.