Innoventric’s Unica System to Treat Severe TR Granted FDA Breakthrough Device Designation

April 10, 2026—Innoventric, an Israel-based medical device company, announced that its Unica system for the treatment of severe tricuspid regurgitation (TR) has been granted FDA Breakthrough Device designation. The announcement was made in a social media posting on LinkedIn.

The company advised it will continue to expand its clinical outreach and prepare for an upcoming global study.

Innoventric stated that the Unica system utilizes a crosscaval anchoring approach that simplifies the procedure and offers a safe, effective, and anatomy-agnostic solution to treat the majority of patients with TR who currently are either high risk or ineligible for transcatheter treatments.

According to the company, the FDA designation underscores the Unica device’s clinical potential and market necessity in a population with significant unmet clinical need and limited therapeutic alternatives. The designation will provide prioritized FDA review, interactive feedback, and an accelerated pathway to bringing Innoventric’s technology to the United States market, noted the company’s posting.