Conformal Medical has announced the initiation of patient enrolment in the European Union (EU) for the CONFORM pivotal trial. The first EU procedure was successfully performed at the Institut Cardiovasculaire Paris Sud (ICPS) in Paris, France by Philippe Garot.
The CONFORM pivotal trial is evaluating the CLAAS AcuFORM LAAO device, a novel foam-based implant designed to provide a simplified, anatomy-conforming solution for stroke prevention in patients with non-valvular atrial fibrillation (AF).
“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 AF,” said Garot. “We are excited to participate in the CONFORM pivotal trial and to help bring this next-generation therapy to patients across Europe.”
The expansion of the CONFORM trial into the EU marks a significant milestone for Conformal Medical, underscoring both the scalability of the study and the global opportunity for the CLAAS AcuFORM system, the company said in a press release. This phase of the trial is designed to generate robust real-world evidence, drive physician adoption, and lay a strong foundation for future commercialisation.
“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,” said James Reinstein, president and chief executive officer of Conformal Medical. “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.”
