Innoventric provides the Unica™ heterotopic cross‑caval system, a transcatheter implant that treats severe tricuspid regurgitation by creating a controlled flow pathway between the superior and inferior vena cava and the right atrium, bypassing the native valve. Its anatomy‑agnostic design, low‑profile 26 Fr delivery system, and ability to be implanted under conscious sedation without TEE or general anesthesia enable clinicians to treat high‑risk patients who are ineligible for existing transcatheter therapies.
Funding
$28.5M raised to dateRaised to date based on public sources. This may differ from the amount the company actually raised and is based only on what is publicly available on the internet.
3OFounders
Product
Problem
Patients with severe tricuspid regurgitation (TR) often cannot receive existing transcatheter therapies because of complex valve anatomy, high procedural risk, or the need for general anesthesia and extensive imaging. This leaves a substantial “still forgotten” patient population without effective, minimally invasive treatment options.
Solution
Innoventric offers the Unica™ heterotopic cross‑caval system, a transcatheter implant that treats TR by creating a controlled flow pathway between the superior and inferior vena cava and the right atrium, bypassing the native tricuspid valve. The anatomy‑agnostic design accommodates a wide range of caval sizes and shapes, providing secure anchoring, migration resistance, and reliable sealing while preserving hepatic vein inflow. The low‑profile 26 Fr delivery system enables transfemoral implantation under conscious sedation without the need for transesophageal echocardiography or general anesthesia, reducing procedure time and hospital stay. Durable bi‑leaflet tissue valves and engineered skirts ensure long‑term fatigue resistance and effective backflow prevention. Clinicians can treat high‑risk patients who were previously ineligible for TEER, TTVR, or bi‑caval valve replacement, expanding access to safe and effective TR therapy.
Target Audience
Primary customers are interventional cardiologists and cardiac surgery programs treating high‑risk TR patients, as well as hospitals and heart‑failure centers seeking minimally invasive, anatomy‑agnostic solutions for patients unsuitable for conventional valve interventions.
Features
- Anatomy‑agnostic dual‑caval anchoring (SVC & IVC) providing full migration resistance
- Two tri‑leaflet biological tissue valves delivering unidirectional flow into the right atrium
- Flexible hinge and broad‑size skirts (SVC fabric skirt, IVC sealing flange) to fit diverse anatomies while preserving hepatic vein flow
- Low‑profile 26 Fr transfemoral delivery system allowing implantation under conscious sedation without TEE or general anesthesia
- Mechanically durable construction tested for 600 million cycles, ensuring decades of fatigue resistance
- Simple, short implantation (≈5 min device deployment, 10 min skin‑to‑skin) with minimal procedural complexity