Pi-Cardia, a developer of non-implant, catheter-based solutions for treating heart valves, has announced successful first-in-human procedures with its ShortCut device.
ShortCut is a dedicated device designed to split the leaflets of a pre-existing valve to enable safe Transcatheter Aortic Valve Replacement (TAVR) in patients at risk for coronary obstruction or compromised coronary access.
The TAVR market, currently estimated at $5 billion, is predicted to double over the next five years, with the expansion into low-risk younger patients. However, this growth may be hindered by a fundamental challenge: During TAVR implantation, the leaflets of the pre-existing valve are pushed sideways, in a way which may compromise future coronary access in many patients. This can turn into a life-threatening complication of complete coronary obstruction in about one third of the patients who undergo a second valve implantation when their previous bio-prosthetic valve degenerates. ShortCut may be used in both situations to split the pre-existing valve leaflets to enable future coronary intervention and prevent coronary obstruction.
The first ShortCut cases were performed in Shaare Zedek Medical Centre in Jerusalem by Dr. Danny Dvir - a leading expert in the field, who was the first to perform BASILICA procedures to prevent coronary obstruction in TAVR.
He said: “Using ShortCut we were able to treat two extremely complex patients with degenerated valves that needed a solution to prevent coronary obstruction after TAVR. In both patients we were able to effectively split the leaflets within minutes, allowing for a safe implantation of both self-expanding and balloon expandable TAVR valves. ShortCut addresses an unmet need for a simple tool to prevent coronary obstruction, which I strongly believe can easily be adopted by all TAVR centres. I can also see ShortCut being used to prepare bicuspid valves in selected cases, by splitting the fused leaflets or tri-cuspidizing the bicuspid valves, enabling an optimal TAVR result in this patient population.”
ShortCut is the latest addition to Pi-Cardia’s product offering, which includes the Leaflex device – a standalone, non-implant-based treatment for patients with aortic stenosis. Leaflex performs mechanical scoring of valve calcification, in order to restore leaflet mobility and improve haemodynamics. Clinical trials are underway in the US, Europe, and China.
Erez Golan, Pi-Cardia’s chief executive officer, said: “We are very excited about this key milestone of demonstrating clinical feasibility with ShortCut, which allows us to move forward with our clinical plan in the US and Europe. As the number of patients with aortic stenosis continues to grow, both Shortcut and Leaflex may offer important new treatment options for both physicians and patients.”
