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.
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The German Institute for Hospital Remuneration (InEK) has renewed the NUB Status 1 designation of VasQ™ External Support for 2021. NUB Status 1 provides supplemental reimbursement for innovative medical devices that have the potential to improve the standard of care for patients. VasQ™ External Support first received NUB Status 1 in 2017 with 35 participating hospitals. It has since grown to 321 participating hospitals to date, which is the second highest among devices that serve the dialysis patient population.
The VasQ™ External Support is implanted around the anastomosis during the creation of an arteriovenous fistula (AVF) to promote more usability without the need for the frequent additional procedures typically required for standard AVFs. In seven clinical studies, VasQ AVFs have reported usability rates as high as 86% or better by 6 months. Growing clinical evidence in support of VasQ, as well
VasQ™ External Support Awarded NUB Status 1 Reimbursement Renewal for 2021 for 321 Hospitals
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BERLIN, Feb. 1, 2021 /PRNewswire/
The German Institute for Hospital Remuneration (InEK) has renewed the NUB Status 1 designation of Laminate Medical s VasQ™ External Support for 2021. NUB Status 1 provides supplemental reimbursement for innovative medical devices that have the potential to improve the standard of care for patients. VasQ™ External Support first received NUB Status 1 in 2017 with 35 participating hospitals. It has since grown to 321 participating hospitals to date, which is the second highest among devices that serve the dialysis patient population.
The VasQ™ External Support is implanted around the anastomosis during the creation of an arteriovenous fistula (AVF) to promote more usability without the need for the frequent additional procedures typically required for standard AVFs. In seven clinical studies, VasQ AVFs