Pi-Cardia Ltd. has secured FDA clearance for its ShortCut device, a novel solution designed to mitigate the risk of coronary obstruction during valve-in-valve transcatheter aortic valve replacement (TAVR) procedures. This clearance marks a significant advancement in the management of aortic stenosis, particularly as TAVR becomes increasingly prevalent in younger patients.
Addressing Coronary Obstruction in Valve-in-Valve TAVR
When a TAVR device fails, a valve-in-valve procedure is often performed to avoid repeat open-heart surgery. However, this approach carries the risk of coronary obstruction due to the displacement of the original valve's leaflets. Studies have shown obstruction rates ranging from 2.6% to as high as 7% depending on the device used. The ShortCut device addresses this issue by mechanically splitting the aortic valve leaflets before the new valve is implanted.
ShortCut's Mechanism and Clinical Validation
Unlike the BASILICA procedure, which uses electrosurgery, ShortCut employs a blade to mechanically split the leaflets. A first-in-human study indicated that while BASILICA is effective, it demands highly skilled operators. Martin Leon, director of the Center for Interventional Vascular Therapy at New York-Presbyterian, highlighted that the pivotal ShortCut study demonstrated the procedure's controlled and teachable nature. This ease of use allows for broader adoption as a pre-implantation step, ensuring safer treatment for patients at risk of coronary obstruction without disrupting the TAVR workflow.
Implications for Aortic Stenosis Management
With TAVR surpassing surgery as the preferred treatment for aortic stenosis, even in patients under 65, the need for valve-in-valve procedures is expected to rise as bioprosthetic valves degenerate over time. Philippe Généreux, MD, from Morristown Medical Center, projects that by 2035, over 42,000 valve-in-valve procedures will be performed annually in the U.S., representing approximately 15% of all TAVR procedures. Pi-Cardia anticipates that future expansions into native and bicuspid valves could mean that around 30% of TAVR cases will require leaflet modification with ShortCut to ensure optimal patient outcomes.
Commercialization and Future Directions
Pi-Cardia is currently building a commercial and clinical support team to facilitate a limited launch of the ShortCut device. Erez Golan, CEO of Pi-Cardia, expressed the company's commitment to collaborating with physicians and hospital systems to ensure access to this technology. The company is also developing additional leaflet modification technologies to expand treatment options for challenging anatomies, such as bicuspid valves.
