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Vascular Graft Solutions Wins FDA approval to Market the VIOLA™ Clampless Proximal Anastomosis System for CABG
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TEL AVIV, Israel, March 1, 2021 /PRNewswire/ Vascular Grafts Solutions (VGS) Ltd. announced today receipt of marketing clearance from the Food and Drug Administration (FDA) for the VIOLA™, a new device for clampless proximal anastomosis in coronary artery bypass grafting (CABG).
VIOLA™, now approved for sales in the US
Neurocognitive dysfunction remains the most devastating perioperative complication of CABG and frequently attributed to atheroembolism that originate from the ascending aorta. The VIOLA™ device minimizes aortic manipulation during on and off-pump CABG and enable cardiac surgeons to perform protected, clean, and dry proximal anastomosis without partial clamping the aorta.