Pi-Cardia has received Investigational Device Exemption (IDE) approval from the US Food and Drug Administration (FDA) to commence the ShortCut Pivotal Study, which will assess the safety and effectiveness of the ShortCut device.
ShortCut is 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.
During TAVI, the leaflets of the pre-existing valve are pushed sideways, in a way which may compromise future coronary access in some patients, Pi-Cardia detailed in a press release. The company adds that this can turn into a life-threatening complication of complete coronary obstruction in a significant number of patients who undergo a second valve implantation when their previous bio-prosthetic valve degenerates. ShortCut may be used to split the pre-existing valve leaflets and is designed to prevent coronary obstruction, potentially enhancing the safety of valve-in-valve procedures and expanding the TAVI market, the company notes.
“Lifetime management for patients with aortic stenosis is increasingly important as we use bio-prosthetic valves more frequently in younger patients, and these valves degenerate over time,” said Susheel Kodali (New York Presbyterian/Columbia University Medical Center, New York, USA) and US ShortCut Study principal investigator. “When we then need to implant a second or third valve in a patient, the ShortCut device can simply split the leaflets of the previous valve and is designed to facilitate a safe TAVI. Procedures performed to date outside the USA demonstrate that ShortCut was able to effectively split the leaflets within minutes, allowing for a safe implantation of both self-expandable and balloon-expandable TAVI valves. We are so excited to join our European colleagues and start enrolling patients in the US soon.”
“The IDE approval of the ShortCut Pivotal Study represents a major milestone, which allows us to now 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 in the USA, coming to market as early as 2024. At the same time, we are making great progress demonstrating the feasibility of our leaflet modification technologies, namely ShortCut and Leaflex, in enabling treatment of bicuspid valves and mitral valves. Each of these future indications represent a significant additional market opportunity for Pi-Cardia.”
ShortCut was among the headline innovations to emerge from two of the summer’s major conferences in the structural heart and interventional cardiology space, TVT (The Structural Heart Summit, 8–10 June, Chicago, USA) and EuroPCR 2022 (17–20 May, Paris, France).