Vascular Graft Solutions today announced that it has received FDA approval for its Viola clampless anastomosis in coronary artery bypass grafting.
The Viola device is designed to minimize aortic manipulation during on and off-pump coronary artery bypass grafting (CABG) to enable cardiac surgeons to perform protected, clean and dry proximal anastomosis without partial clamping the aorta.
“The Viola has important design features that provide reliable and safe mechanism for constructing clampless proximal anastomoses,” Gil Bolotin, director of the cardiac surgery department at Rambam Medical Center in Israel, said in a news release. “The integrated punching mechanism, the excellent sealing quality which makes blower unnecessary and the ability to perform multiple anastomoses with a single device makes the Viola a very attractive tool in our operating room.”
“We are very excited about this important milestone,” founder and CEO Eyal Orion said. “Our vision has always been to advance cardiovascular surgery. We are committed to this long journey and in the last decade, we were able to develop solutions that address the biggest unmet needs in CABG: vein graft failure and perioperative neurological complications. FDA approval of the Viola device is a pivotal point for us. Gradually, our focus will shift from generating high quality science that shows the benefits of our technologies to making our solutions a new standard of care in CABG. I would like to thank my dedicated team and all the cardiovascular surgeons that have been working with us shoulder to shoulder to improve patients care.”