Completion of patient enrollment in the company’s US Investigational Device Exemption randomized, controlled pivotal study, evaluating the efficacy of the VEST external support for saphenous vein grafts in coronary artery bypass surgery.
| TEL AVIV, Israel, March 5, 2019 /PRNewswire/ -- Vascular Graft Solutions Ltd. (VGS) announces the completion of patient enrollment in the company’s US Investigational Device Exemption (IDE) randomized, controlled pivotal study, evaluating the efficacy of the VEST external support for saphenous vein grafts in coronary artery bypass (CABG) surgery.
The study enrolled 224 patients at 17 clinical sites in the US and Canada, under the auspices of the NIH/NHLBI supported Cardiothoracic Surgical Trials Network (CTSN), a nation-wide network of premier cardiac surgical centers who collaborate to design and conduct the most important clinical trials in cardiac surgery. “It is an important milestone and another step in accomplishing our vision to introduce high impact innovation to cardiovascular surgery,” said Eyal Orion, M.D., Founder and CEO of VGS. “I would like to thank our amazing clinical team at VGS, our wonderful partners at the CTSN and the national principal investigators of the VEST U.S. trial, Dr. John Puskas of Mount-Sinai Hospital, and Dr. Daniel Goldstein of Montefiore hospital in New-York. The fast recruitment to this study is a recognition for both its clinical importance and the potential of our technology. In the last two years we built research partnerships and infrastructure in the U.S. that will enable VGS to accelerate the clinical development of our platform of external scaffolds for peripheral bypass and reconstruction of high flow AV fistula in dialysis patients.” “The trial leadership and clinical Investigators are very pleased to have enrolled all 224 patients into the VEST FDA Trial so quickly and smoothly,” said Dr. Puskas. “This is, in part, due to the ease of use of the device and its ready acceptance by surgeons and patients at our Network centers. We are now beginning to perform the follow-up angiograms on the first patients enrolled in the trial one year ago and look forward to acquiring the data that will report the efficacy of the VEST device in preventing neointimal hyperplasia in saphenous vein grafts. This trial has the potential to significantly change clinical practice in coronary bypass surgery.” “We are extremely pleased to announce completion of enrollment into the NIH-VEST trial ahead of schedule,” said Dr. Goldstein. “Achievement of this 224 patient milestone was the result of the diligence and enthusiasm of the investigators who offered their patients participation in an investigation that could markedly improve the outcomes of coronary bypass surgery which has been traditionally limited by the development of saphenous vein neointimal hyperplasia. We are now entering the period of primary endpoint data acquisition and eagerly anticipate completion of the trial in first quarter 2020.” About VGS VGS is a privately held company located in Tel Aviv, Israel. The company develops novel solutions in the field of cardiovascular surgery. VEST is a CE marked external support device for treatment of saphenous vein grafts in coronary bypass procedures. VEST targets the root causes of vein graft failure. The device underwent several randomized trials in leading heart centers in Europe, was implanted successfully in approximately 3,000 patients and is commercialized in several EU countries, Mexico and South Africa. Contact:
SOURCE Vascular Grafts Solutions |
View original content to download multimedia:
