P&F USA secures FDA approval for expansion of the TRICAV I study for severe Tricuspid Regurgitation

P&F Products & Features News Release

On December 19, 2024, the US Food and Drug Administration (FDA) approved the expansion of the TRICAV I study for the TricValve® Transcatheter Bicaval Valve System* from 15 patients to 50 patients at a total of 50 sites in the United States via the Investigational Device Exemption (IDE) G240065. The TRICAV I study is a single-arm clinical trial designed to investigate the groundbreaking TricValve System* and offers a unique option to improve right-heart failure symptoms (RHF) in patients with severe Tricuspid Regurgitation (TR). The procedure is performed via a minimally invasive transcatheter approach with unique bicaval valves being implanted into the inferior (IVC) and superior vena cava (SVC). Thus reducing the backward blood flow inherent to severe TR and resulting in significant symptom relief.

The FDA initially approved IDE G240065 (NCT06137807) for 15 patients at a total of 15 sites. Previously, a total of 36 patients were treated through compassionate use in the US and Special Access Pathway (SAP) in Canada. The clinical data were presented at the NY Valves conference in New York in June 2024.

TRICAV I study is a prospective multicenter clinical study designed to evaluate the safety and effectiveness of the TricValve System to improve clinical outcomes and symptoms in patients with severe TR who are deemed unsuitable or at high risk for tricuspid repair and surgery by the local Heart Team and who meet the study’s inclusion criteria.

Literature estimates that more than 1.6 million people in the US are affected by TR. People with severe TR face a low survival rate, regardless of their general health or management of the condition with medication such as diuretics. Many symptomatic patients are deemed unsuitable for open heart surgery, and medical specialists consider the risk of surgical complications too high for these patients due to disease severity and comorbidities.

Hon. Prof. Katharina Kiss, MD, CEO and Co-Founder of P&F, says the TRICAV I study will potentially give these patients hope for improved quality of life. “Many patients with severe TR in the US cannot be treated with open heart surgery or existing procedures due to their anatomy or the high risk of complications. The TricValve system offers these patients an alternative through this safe and minimally invasive therapy,” Dr. Kiss said. “The TricValve system is CE marked in Europe, commercially available in ~70 countries around the globe, and has FDA Breakthrough designation. The system has been successfully implanted in over 1,000 patients in several countries. We look forward to supporting this therapy with the current expansion and eventually with world-class evidence to be generated through the TRICAV I study.”

*Investigational device. Limited by Federal (or United States) law to investigational use.

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