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First-in-Human Implantation of Ultra-low Profile TAVR Valve

Valve Medical Announces Successful First-in-Human Implantation of Ultra-low Profile TAVR Valve in Israel

May 31, 2023

TEL AVIV, Israel, May 31, 2023 /PRNewswire/ — Valve Medical, a wholly owned subsidiary of Medinol Ltd. is pleased to announce today the successful First-in-Human (FIH) implantation of the Xemed Transcatheter Aortic Valve Replacement (TAVR) system in Israel, introducing a revolutionary advancement in Structural Heart procedures with the world’s first modular valve.

The Valve Medical Xemed TAVR device is a transformational technology designed to improve patient outcomes and procedural success. The distinguishing feature of the valve is its modular design, which has an ultra-low profile, enabling the use of a standard 12 Fr sheath. This reduction in size allows for universal access to trans-femoral delivery for all patients, including those with smaller arteries, while reducing the risk of vascular and bleeding complications, still common in TAVR procedures. Furthermore, the profile simplifies vessel closure at the end of the procedure, which reduces procedure times and workload for physicians and supporting staff. In addition to its profile, the device incorporates multiple technical advances including a unique adaptive sealing technology to reduce paravalvular leakage, a common complication of TAVR.

“We were impressed with the device and its straightforward implantation,” said Prof. Ran Kornowski, the implanting physician at Rabin Medical Center. “The low profile will allow us to treat most patients by making the procedure safer and more accessible to a broader population.”

Dr. Yoram Richter, founder and Chief Scientific Officer of Valve Medical, added: “We believe the ultra-low profile, adaptive sealing, ease of coronary access and advanced frame shape broaden the applicability of the device to more people, providing clinical benefits to both patients and physicians.”

“We are also excited to announce that we are in the advanced stages of reducing the profile of the device even further to 9 Fr,” states Dr. Yoram Izhaki, CEO.

Aortic stenosis is a common valvular disease that affects millions of people worldwide. TAVR is a minimally invasive procedure that replaces the damaged aortic valve with a new valve without the need for open-heart surgery. It is a life-saving procedure for patients who are not candidates for surgery.

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