Valve Medical, a wholly owned subsidiary of Medinol Ltd, has announced the first-in-human (FIH) implantation of its “modular” transcatheter aortic valve implantation (TAVI) system in Israel, Xemed.
The Valve Medical Xemed TAVI device is designed to improve patient outcomes and procedural success, the company says in a press release, noting that the modular design, features an ultra-low profile, enabling the use of a standard 12Fr sheath.
According to the company, the reduction in size allows for universal access to transfemoral delivery for all patients, including those with smaller arteries, while reducing the risk of vascular and bleeding complications, still common in TAVI procedures.
Additionally, the company says in its press release, 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.
“We were impressed with the device and its straightforward implantation,” said Ran Kornowski, the implanting physician at Rabin Medical Center (Tel Aviv, Israel). “The low profile will allow us to treat most patients by making the procedure safer and more accessible to a broader population.”
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.”
Yoram Izhaki, CEO of Valve Medical, has also announced that the company is seeking to reduce the profile of the device to 9Fr.