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.”

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine provides our readership with breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

More News!

The KnowU incorporates the sensor that the Company plans to submit to the FDA for clearance. This proprietary sensor has been tested and proven stable and accurate in the lab setting. It was included in the Company’s prototype to validate stability outside of the lab, and is now miniaturized and wearable.
The ArthroFree system is the first FDA-cleared wireless camera for arthroscopy and general endoscopy, both areas of minimally invasive surgery. The system is designed to help surgeons work with aximum dexterity and focus.
The project, which was led by the University of Southern California, included large increases in representation among men of African, Hispanic and Asian ancestries, that were contributed in part by an ongoing collaboration between the U.S. Department of Veterans Affairs and DOE reports Argonne.
This innovative software turns smartphones into medical-grade stethoscopes, allowing people to capture, analyze, and share critical heart health data with medical personnel from the comfort of any location notes Sparrow BioAcoustics.
"Taewoong Medical becoming an Olympus group company is also a major milestone in our global growth strategy," said Henry Shin, CEO of STARmed. "We look forward to our products being made available to more patients through Olympus' global distribution network."

By using this website you agree to accept Medical Device News Magazine Privacy Policy