Pi-Cardia’s ShortCut Pivotal Study Completes Enrollment

September 20, 2023—Pi-Cardia Ltd., an Israel-based developer of nonimplant, catheter-based, leaflet modification solutions for treating heart valves, announced the completion of enrollment in its ShortCut pivotal study. The ShortCut device is designed to split the leaflets of pre-existing valves to enable safe transcatheter aortic valve replacement (TAVR) in patients at risk of coronary obstruction.

According to the company, the ShortCut pivotal study was conducted at 20 TAVR centers in the United States and Europe. The study 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. In December 2022, the company announced the study enrolled its first patient in the United States after announcing FDA approval of an investigational device exemption for the study in July 2022.

Baseline data will be presented at TCT 2023, the 35th annual Transcatheter Cardiovascular Therapeutics scientific symposium to be held October 23-26 in San Francisco, California.

Pi-Cardia noted that the ShortCut device is intended to address a challenge in TAVR implantation, in which the leaflets of pre-existing valves are pushed sideways, compromising normal flow in the sinuses and hindering coronary access. This can lead to complete coronary obstruction in a significant number of patients, especially those who undergoing TAVR to treat a failing bioprosthetic valve.

ShortCut enables the pre-existing valve leaflets to be split, thereby facilitating a safer valve-in-valve procedure, and potentially broadening the TAVR market’s reach to younger patients.

The pivotal study was conducted under the leadership of Susheel K. Kodali, MD; Didier Tchétché, MD; and Danny Dvir, MD. Dr. Kodali is from New York Presbyterian/Columbia University in New York, New York. Dr. Tchétché is from Clinique Pasteur in Toulouse, France. Dr. Dvir is from Sha’are Zedek Medical Center in Jerusalem, Israel.

“We are excited to have been able to complete enrollment in such a groundbreaking study so efficiently,” commented Dr. Kodali in the company’s press release. “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 United States in the near future.”

Dr. Dvir added, “We’ve spent years looking for techniques to overcome the life-threatening complication of coronary obstruction. 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.”

Also, Dr. Tchétché stated, “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. 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.”