Enrollment Completed in Pi-Cardia’s ShortCut Study

Pi-Cardia Ltd. has successfully completed its ShortCut Pivotal Study enrollment. ShortCut is the world’s first dedicated device designed to split the leaflets of pre-existing valves to conduct safe Transcatheter Aortic Valve Replacement (TAVR) in patients at risk of a coronary obstruction.

“We are thrilled having completed enrollment months ahead of schedule,” Pi-Cardia CEO Erez Golan stated. “This milestone not only validates our market models predicting a significant percentage of TAVR patients in need for leaflet modification, but it also means we should be able to commercialize ShortCut in the U.S. and Europe as soon as 2024.”
 
The study was conducted across 20 TAVR centers in the United States and Europe and was led by Drs. Susheel Kodali (New York Presbyterian/Columbia University in New York), Didier Tchétché (Clinique Pasteur in Toulouse, France) and Danny Dvir (Sha’are Zedek in Jerusalem, Israel). It included 60 patients undergoing valve-in-valve procedures, in whom ShortCut was used as a preceding step to TAVR implantation. Data was independently analyzed by central echo and CT core-labs.

“We are excited to have been able to complete enrollment in such a groundbreaking study so efficiently,” Kodali said. “It clearly demonstrates the unmet need for ShortCut and how excited the sites were to learn and perform the procedure. I look forward to the commercial launch of ShortCut in the U.S. in the near future.”
 
The TAVR market, currently estimated at $6 billion, is projected to double over the next five years, with expansion into low-risk younger patients. However, this growth may be hindered by a fundamental challenge: During TAVR implantation, the leaflets of pre-existing valves are pushed sideways, compromising normal flow in the sinuses and hindering coronary access. This can turn into a life-threatening complication of complete coronary obstruction in a significant number of patients, especially those undergoing TAVR to treat a failing bioprosthetic valve. ShortCut offers a promising solution by enabling the pre-existing valve leaflets to be split, facilitating a safer valve-in-valve procedure and potentially broadening the TAVR market’s reach to younger patients.
 
“We’ve spent years looking for techniques to overcome the life-threatening complication of coronary obstruction,” Dvir added. “Having performed multiple ShortCut cases, I can clearly say we’ve found a simple, controlled and teachable solution that integrates well into the workflow of every TAVR center.”

ShortCut is part of Pi-Cardia’s leaflet modification product portfolio, which includes the ShortCut Mitral for splitting leaflets in patients at risk for left ventricular outflow tract obstruction following TMVR, and Leaflex—a standalone, non-implant-based mechanical scoring device to restore leaflet mobility and improve hemodynamics for patients with aortic stenosis. Leaflex global clinical trials currently are underway.
 
“I can see ShortCut becoming instrumental, not only in facilitating safe valve-in-valve procedures, but also for ensuring future coronary access in patients receiving their first TAVR or optimizing TAVR in bicuspid valves,” Tchétché stated. “Lifetime management for patients with aortic stenosis is increasingly important as we treat younger patients. ShortCut holds the key for TAVR to safely expand to these large populations.”

Pi-Cardia has developed non-implant, catheter-based, leaflet modification solutions for treating heart valves. Pi-Cardia’s ShortCut device is designed to provide a safe, simple and effective way to split valve leaflets: ShortCut Aortic splits leaflets of a pre-existing valve prior to TAVR in patients at risk for coronary obstruction and assist in preserving coronary access; ShortCut Mitral splits the anterior mitral leaflet prior to TMVR in patients at risk for LVOT obstruction. Pi-Cardia’s Leaflex device mechanically scores valve calcification at multiple locations, with the intention of restoring leaflet flexibility and improving valve hemodynamics. Leaflex is a cost-effective, durable standalone treatment for patients with calcified aortic stenosis. Additional leaflet modification technologies are being developed to further expand treatment options in challenging anatomies such as bicuspid valves. The ShortCut and Leaflex devices are investigational products, limited by U.S. law to investigational use.