Pi-Cardia has announced that the first patient in the USA has been successfully treated with ShortCut—a dedicated device designed to split the leaflets of a pre-existing valve to enable safe transcatheter aortic valve implantation (TAVI) in patients at risk for coronary obstruction.
Pi-Cardia received Investigational Device Exemption (IDE) approval from the US Food and Drug Administration (FDA) to commence the ShortCut Pivotal Study in July 2022 and multiple patients have already been treated successfully outside the USA.
The ShortCut procedure was performed at Morristown Medical Center (Morristown, USA), by Philippe Généreux, Jim Slater, Leo Marcoff, and Robert Kipperman in collaboration with Benjamin Seguy (Hospital Haut Leveque, Bordeaux, France).
“We successfully treated this patient with a degenerated valve who was at risk of coronary obstruction after TAVI with the ShortCut device,” said Généreux. “The targeted leaflet was effectively split within just a few minutes, allowing for safe implantation of the TAVI valve. ShortCut is a real game-changer enabling TAVI treatment in younger patients who will likely need multiple interventions over the course of their lives.”
“Lifetime management for patients with aortic stenosis is increasingly important as we use bioprosthetic valves more frequently in younger patients, and these valves degenerate over time,” said Susheel K Kodali (New York Presbyterian/Columbia University Medical Center, New York, USA) and US ShortCut Study principal investigator. “Oftentimes, we may need to implant multiple valves in a patient, which may entail a risk of coronary obstruction or lack of access. The ShortCut device can simply split the leaflets of the previous degenerated valve and is designed to facilitate a safe TAVI.”
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 after transcatheter mitral valve replacement (TMVR), and Leaflex, a standalone, non-implant-based mechanical scoring device to restore leaflet mobility and improve haemodynamics for patients with aortic stenosis. Leaflex global clinical trials are underway.
“We are very pleased with this milestone of commencing enrolment in the USA, which allows us to move forward with our clinical plan towards commercialisation in the USA and Europe,” said Erez Golan, Pi-Cardia’s chief executive officer. “Given the enthusiasm from US clinicians, we believe ShortCut can be the first dedicated leaflet splitting device coming to market as early as 2024.”
Insights from the first-in-man use of the ShortCut device were presented earlier in 2022 at both TVT 2022 (The Structural Heart Summit, 8–10 June, Chicago, USA) and EuroPCR (17–20 May, Paris, France).