American medical device firm Kips Bay Medical's eMESH I clinical feasibility trial has moved a step further, with first patient enrolling to the study at a European hospital.
Switzerland-based Bern University Hospital has recently enrolled the first patient for this multi-center, randomized study of external saphenous vein support in CABG Surgery using Kips Bay Medical’s eSVS Mesh.
Hospital’s senior consultant cardian surgeon and MD, Dr. Lars Englberger, who observed the enrollment, said that the patient is recovering well, after undergoing a quadruple bypass surgery that saw a smooth and uneventful implant of the Kips Bay’s mesh graft.
"I think that the eSVS Mesh® will be a very valuable tool to increase mid- and long-term patency of saphenous vein grafts, further improving clinical outcomes of patients undergoing CABG surgery by lowering the need for coronary re-interventions," Dr. Englberger added.
The study seeks to demonstrate the initial safety and performance of the eSVS Mesh, required by the USFDA to approve an IDE for the study in the US, according to the announcement by the company’s chairman and CEO Manny Villafaña.
With plans underway to enroll about 120 patients at eight European hospitals, Kips Bay said it will constantly pursue FDA to approve the inclusion of four US hospitals for the trial.
The company is also pursuing with noted US heart centers to obtain internal approvals of their institutional review boards and administrations to take part in the trial.