ShortCut
Pi-Cardia Ltd.The ShortCut device by Pi-Cardia Ltd. is a single-use catheter designed to safely split bioprosthetic aortic valve leaflets to facilitate valve-in-valve procedures in patients at risk of coronary obstruction. This catheter-based tool is inserted via the femoral artery and positions its distal cutting element on valve leaflets to perform precise cuts, helping improve blood flow and reduce complications during transcatheter valve replacement procedures. It has been demonstrated in clinical studies to be effective and safe, providing a new treatment option for high-risk patients undergoing valve-in-valve procedures.
Intended Use
The ShortCut is indicated for use as a splitting device of bioprosthetic aortic valve leaflets to facilitate valve-in-valve procedures for patients at risk of coronary obstruction.
Technology
ShortCut is a single use transfemoral catheter with a distal splitting element and positioning arm. It is delivered through a 16 Fr introducer sheath over a guidewire, designed to penetrate and split valve leaflets immediately prior to valve-in-valve TAVR procedures. The device includes a handle to control delivery and positioning. It has no active electrical components and is sterilized by ethylene oxide.
Performance
Clinical pivotal study with 60 subjects showed 100% per subject splitting success, 0% mortality and 1.7% stroke rate within 7 days, comparable to standard TAVR risks. Secondary endpoints showed 97.6% per-leaflet split success and 5% coronary obstruction, all treated percutaneously. Nonclinical and animal tests confirmed mechanical integrity, biocompatibility, and safe use. Compassionate use cases also showed no adverse events related to the device.
Device Timeline
- 1
Submission
4/17/2024
5 months - 2
FDA Approval
9/27/2024
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