Vascular Graft Solutions has announced interim results of VEST III, a post-market randomised controlled study, to demonstrate the clinical significance of the venous external support (VEST) device—a kink resistant cobalt-chromium braided external stent applied on the outer surface of saphenous vein grafts when used in coronary artery bypass grafting (CABG). The interim results from the German and Austrian arms of the study, according to a press release, show there are no safety concerns around the application of VEST™ and excellent patency rate six months post-surgery
The press release reports that the results were presented as part of the “CABG in 2017: Status & Innovations symposium at DGTHG in Leipzig in February. It adds that the randomised controlled study involved nearly 200 patients at leading heart centres across the UK, Germany, Austria and Israel and is designed to evaluate the efficacy of the VEST device in mitigating vein graft disease and improving the clinical outcome of CABG.
In the German and Austrian arms of the study, led by Ivar Friedrich, 91 patients were enrolled in seven heart centres. Interim findings from 68 patients who completed the six months follow-up, demonstrated early patency of 98% in the VEST supported vein grafts. This underscores the high level of surgical proficiency of the surgeons involved, the safety profile of VEST and the improvement in early patency compared to other external stenting technologies tested in the past.
Friedrich comments: “Arterial pressure coupled with abnormal flow patterns generated mainly by luminal irregularities are the main contributors to the aggressive disease that develops in the vein graft over time. VEST is a simple and elegant device, which is easily applied during CABG and targets to root causes of vein graft disease. Improving vein graft longevity is crucial to improve the clinical outcome of CABG and to maintain its important role in the treatment of coronary disease.”
VEST received CE mark approval in 2014, and has been implanted successfully in more than 700 patients across Europe. It is the only proven technology to mitigate vein graft disease five years after surgery.