Conformal Medical has commenced subject enrolment within the EU for its CONFORM Pivotal Trial of the CLAAS AcuFORM left atrial appendage occlusion (LAAO) device.
The inaugural procedure was conducted at France’s Institut Cardiovasculaire Paris Sud by Interventional Cardiology head Dr Philippe Garot.
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The multicentre, prospective, randomised controlled trial is focused on assessing the foam-based implant engineered to offer an anatomy-conforming solution for prevention of stroke in individuals with non-valvular atrial fibrillation (AFib).
It compares the efficacy and safety of the system with other existing left atrial appendage devices on the market.
The study aims to randomise roughly 1,600 subjects across various global locations and has already enrolled more than 30% of its target.
Its primary goal is to collect critical data that will support the advancement of next-generation stroke prevention treatments for individuals with non-valvular AFib who are exploring alternatives to long-term oral anticoagulation therapy.
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By GlobalDataGarot said: “The CLAAS AcuFORM system represents an important innovation in LAAO, with the potential to simplify procedures, expand access and improve outcomes for patients with non-valvular AFib.
“We are excited to participate in the CONFORM Pivotal Trial and to help bring this next-generation therapy to patients across Europe.”
By tapping into Europe’s healthcare infrastructure and clinical networks, the trial aims to produce real-world data, encourage physician engagement and establish groundwork for future market introduction.
Conformal Medical CEO and president James Reinstein said: “Partnerships with leading European centres strengthen our global presence, accelerate innovation and position us to deliver the benefits of our differentiated technology to patients worldwide.
“We believe the CLAAS AcuFORM system will be a competitive offering, with its ability to conform to individual anatomies, simplify procedures with just two device sizes and provide reliable seal confirmation.”
