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Vascular Graft Solutions Wins FDA Approval to Market the VIOLA Clampless Proximal Anastomosis System for CABG

March 1, 2021

Vascular Graft Solutions Ltd. announced today receipt of marketing clearance from the Food and Drug Administration for the VIOLA™, a new device for clampless proximal anastomosis in coronary artery bypass grafting (CABG).

Neurocognitive dysfunction remains the most devastating perioperative complication of CABG and frequently attributed to atheroembolism that originates from the ascending aorta. The VIOLA™ device minimizes aortic manipulation during on and off-pump CABG and enables cardiac surgeons to perform protected, clean, and dry proximal anastomosis without partial clamping the aorta.

“The VIOLA™ has important design features that provide a reliable and safe mechanism for constructing clampless proximal anastomoses,” said Professor Gil Bolotin, Director of Cardiac Surgery Department at Rambam Medical Center, Israel. “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”, said Eyal Orion, M.D., Founder and CEO of Vascular Graft Solutions Ltd. “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.

He added, “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.”

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Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

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