Vascular Graft Solutions (VGS) has started a trial in the US to assess the safety and effectiveness of its VEST technology in bypass surgery.
The company has started enrollment of the first 20 patients into pivotal trial of VEST, an external support device for treating saphenous vein graft disease after coronary artery bypass grafting (CABG).
The trial is being undertaken in the US 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.
VGS' 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. This device is claimed to have undergone several randomized trials at some of the heart centers in Europe and implanted in more than 1,000 patients. It was also commercialized in several European countries.
VGS founder and CEO Eyal Orion said: "After more than 1,000 successful implantations in Europe, we are excited to achieve this important milestone and begin our pivotal trial in the US.
"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 US and hope that together, we will bring a new era in the field of coronary revascularization."
CTSN Data Coordinating Center principal investigator (PI) and Icahn School of Medicine at Department of Population Health Science & Policy Chair Annetine Gelijns stated that CTSN’s goal is to foster a culture of rigorous scientific comparison and to promote the evaluation of surgical procedures, devices and related management strategies for improving cardiovascular disease outcomes.
The VEST trial is an important collaboration between researchers, FDA, and NIH to conduct high-impact clinical research to investigate a new device and test its utility in an academically rigorous fashion.
The study will be conducted under the clinical leadership of John Puskas of Mount-Sinai Hospital and Daniel Goldstein of Montefiore hospital in New-York.
Image: John D. Puskas & Daniel J. Goldstein, joint PIs for the VEST US trial. Photo: Courtesy of PR Newswire.