VGS Initiates U.S. Pivotal Trial to Evaluate the Use of Its VEST Technology for Bypass Surgery
23 Apr, 2018, 09:00 ET
TEL AVIV, Israel, April 23, 2018 /PRNewswire/ -- Vascular Graft Solutions Ltd (VGS) announces on enrollment of the first 20 patients into the VEST US pivotal trial that will evaluate the safety and effectiveness of the VEST, a novel external support device for treatment of saphenous vein graft disease after coronary artery bypass grafting (CABG).
"After more than 1,000 successful implantations in Europe, we are excited to achieve this important milestone and begin our pivotal trial in the U.S." said Eyal Orion, founder and CEO of VGS. "The VEST US trial is a fantastic example of collaboration between state of the art researchers, surgeons, and innovators that share real enthusiasm for promoting technologies that can significantly affect the lives of millions. We are honored to work with our partners in the U.S. and hope that together, we will bring a new era in the field of coronary revascularization."
The VEST trial is being conducted in the United States under an FDA Investigational Device Exemption (IDE) and under the auspices of the NIH-sponsored 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.
"Our goal in CTSN is to foster a culture of rigorous scientific comparison and to promote the evaluation of surgical procedures, devices, and related management strategies, directed at improving cardiovascular disease outcomes," said Dr. Annetine Gelijns, principal investigator (PI) of the CTSN Data Coordinating Center and Chair of the Department of Population Health Science & Policy at Icahn School of Medicine at Mount Sinai, NY. "The VEST trial represents an important collaboration between researchers, FDA, and NIH to conduct high-impact clinical research that investigates a novel device and tests its utility in an academically rigorous fashion." The study is conducted under the clinical leadership of Drs. John Puskas of Mount-Sinai Hospital and Dr. Daniel Goldstein of Montefiore hospital in New-York.
The first two VEST implantations were performed by Dr. Jakobleff and Dr. Scheinin at Montefiore hospital in NY under the direction of Dr. Daniel Goldstein, the joint PI for the VEST US trial. "The first VEST implantations went smoothly," said Dr. Goldstein. "The device is elegant, simple to use and requires minimal change in our grafting technique. Positive findings from this trial will enable us to quickly and significantly improve the outcome of bypass surgery without the need to acquire new surgical or technical skills. This is a big advantage." Seven centers were the first to be opened for enrolment and are currently recruiting patients. Baylor Heart Hospital (Plano, TX), Lutheran Hospital (Fort Wayne, IN), Dartmouth-Hitchcock (Lebanon, NH), University of Pennsylvania Medical Center (Philadelphia, PA), Montefiore Hospital, New York-Presbyterian/Columbia Medical Center, and Mount Sinai Saint Luke's (New York, NY). All twenty implantations were successfully completed and surgeons provide positive feedback on integration of VEST into the routine CABG procedure.
"I am proud to serve as the joint PI for the VEST trial in the USA. This is one of the most exciting potential cardiovascular therapies to be rigorously tested in many years," said Dr John Puskas, Chairman of the Department of Cardiovascular Surgery at Mount Sinai Saint Luke's and Mount Sinai Beth Israel. "Vein graft failure is considered the 'Achilles Heel' of coronary bypass surgery, limiting its long-term benefit to patients. Any new therapy that could prolong the benefit of coronary bypass surgery for patients would be a very important advancement. Clinical trials at leading academic centers in Europe have shown that the VEST device is safe and associated with a reduction in the early changes in vein grafts that are associated with later closure. Thus, the VEST US trial will test whether the device can improve the function of vein grafts and prevent the early changes in veins that lead to vein failure during long exposure to arterial pressure."
About the Cardiothoracic Surgical Trials Network (CTSN):
The National Institutes of Health (NIH) and the Canadian Institutes for Health Research (CIHR) created the Cardiothoracic Surgical Trials Network (CTSN), whose mission is to design, conduct, and analyze multiple, collaborative clinical trials that evaluate surgical interventions for the treatment of cardiovascular disease in adult patients. The CTSN is composed of a network of clinical sites and investigators across the USA, Canada and Europe, a Data and Clinical Coordinating Center, and several core labs as well as other supporting committees.
VGS is a privately held company located in Tel Aviv, Israel. The company develops novel solutions in the field of cardiovascular surgery. VEST and FRAME, are CE marked external support devices for treatment of saphenous vein grafts in coronary and peripheral bypass procedures respectively. VEST device targets the root causes of vein graft failure. The device underwent several randomized trials in leading heart centers in Europe, was implanted successfully in more than 1,000 patients and is commercialized in several EU countries.
VP Business Development
SOURCE Vascular Grafts Solutions
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