1. Medtech Insight

TRiCares Initiates EU Pivotal Study For Topaz Tricuspid Valve Replacement

 
• By Natasha Barrow

TRiCares announced first implantation of the Topaz transfemoral tricuspid heart valve replacement system as part of the company’s EU pivotal study. If all goes to plan, the device will compete with Edwards’ Evoque system. The announcement follows the company’s $50m series D funding raise in July.

Echocardiographic finding of tricuspid regurgitations • Source: Shutterstock

TRiCares has kicked off an EU pivotal study with the first implantation of its Topaz tricuspid heart valve replacement system (TTVR), performed at the Algemeen Stedelijk Ziekenhuis hospital in Aalst, Belgium.

Topaz represents potential competition for Edwards’ Evoque tricuspid valve replacement system, the first of its kind to reach market following US Food and Drug Administration approval in February and CE marking in October 2023

The TRICURE (TRiCares’ Topaz Transcatheter TRICUspid Heart Valve REplacement System) European pivotal study is taking place across 11 European locations, including Germany, Belgium, France and Switzerland. The EU pivotal study follows positive results from the company’s EU first-in-human study, initiated in 2022 and ongoing until 2029. TRiCares has also begun patient enrollment for its US Early Feasibility Study

More from Europe

Consumer Healthtech Investment Totaled $4.5BN In 2024, But Bar Is High Amid Economic Uncertainty

 
• By Marion Webb

Global investment in consumer healthtech increased by 9% year-over-year in 2024, totaling $4.5bn, with significant interest in mental health solutions, according to Galen Growth. While the first quarter of 2025 saw raised confidence and investments, the Trump administration’s new tariffs and sweeping changes to healthcare have introduced new uncertainties.

MedTech Europe’s Bisazza Urges Action As US Tariffs Jeopardize Critical Global Supply Chains

 
• By Amanda Maxwell

The intricate assembly of medical devices, often involving over 1,000 globally sourced components, faces severe disruption due to new US tariffs. These barriers could halt production and devastate small and medium-sized enterprises (SMEs), MedTech Europe’s CEO, Oliver Bisazza, warns in an interview with Medtech Insight.

Don’t Sleep On Inspections: Experts Warn FDA Maintains Enforcement Resources

 
• By Brian Bossetta

Manufacturers of medical products would be foolish to think that recent upheavals at the US FDA will result in a lack of inspections in the coming years. A panel of experts discussed the current state of inspections during a webinar hosted by the Food and Drug Law Institute.

Switzerland Investigates Private Sector Assessment of FDA-Approved Medical Devices

 
• By Amanda Maxwell

Its move comes as the Swiss recognize the need to ensure adequate supplies on medical devices in its country.

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