Conformal Medical, Inc., a medical device company developing next-generation technology for left atrial appendage occlusion (LAAO), announced the initiation of patient enrollment in the European Union for the CONFORM Pivotal Trial. The first E.U. procedure was successfully performed at the Institut Cardiovasculaire Paris Sud (ICPS) in France by Philippe Garot, MD, FESC, Head of the Interventional Cardiology.

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 (AFib).

"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," said Dr. 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 E.U. marks a significant milestone for Conformal Medical, underscoring both the scalability of the study and the global opportunity for the CLAAS AcuFORM system. Leveraging Europe's diverse healthcare systems and well-established clinical networks, 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 CEO 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."