Imagine a leaky heart valve that's too dangerous to fix with traditional surgery. Instead of cutting open the chest, this device acts like a new bypass pipe with a built-in valve, placed safely away from the original leak. It's a quick procedure that doesn't require deep anesthesia or complex imaging to get right.
Over 3 million European patients suffer from tricuspid regurgitation, but many are too high-risk for open-heart surgery. Current transcatheter options fail for 40% of patients due to complex anatomy or prior failures.
A heterotopic cross-caval stent graft with a valved wall. 160 units were produced for V&V testing and clinical trials.
If you are a manufacturer dealing with the lack of options for 40% of TR patients with challenging anatomy — this project developed a heterotopic cross-caval valve that treats patients without touching the native valve. This expands the addressable market to those ineligible for current on-valve treatments.
If you are a clinic dealing with high costs and mortality risks of open-heart surgery — this project developed a replacement solution that takes less than 10 minutes to implant. It removes the need for general anesthesia and rapid pacing, increasing patient throughput.
If you are a CRO dealing with the need for validated TR therapies for 3M patients in Europe — this project developed a device already implanted in 34 patients. It provides a proven pathway for IDE-Pivotal studies in the US and Europe.
Based on available project data, specific pricing or cost per unit is not mentioned.
The project has already produced 160 devices for testing and trials, indicating a functional production process is in place.
Based on available project data, specific patent numbers or licensing terms are not provided, though the technology is developed by Innoventric Ltd.
The device received FDA approval in December 2024 to initiate an EFS trial in the US and is moving toward an IDE-Pivotal study.
The project runs until 2026-05-31, with current focus on validating the final design through EFS and pivotal studies in Europe and the US.
The project is led by a single SME, Innoventric Ltd, based in Israel. With a 100% industry ratio and no university or research partners, the consortium is lean and focused entirely on commercialization and clinical validation rather than basic research.
Contact Innoventric Ltd regarding their IDE-Pivotal study applications.
Contact us to explore partnership opportunities for the upcoming US and European pivotal trials.
