Enrollment Begins in Trial Evaluating Conformal Medical’s LAAO Device

Conformal Medical Inc. has enrolled the first European Union patient in a study designed to assess the efficacy of its CLAAS AcuFORM left atrial appendage occlusion (LAAO) device. The debut EU procedure was successfully performed at the Institut Cardiovasculaire Paris Sud (ICPS) in France by Philippe Garot, M.D., head of the interventional cardiology.

The CONFORM pivotal trial is evaluating the CLAAS AcuFORM device, a foam-based implant that provides 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,” Dr. Garot stated. “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 study’s scalability and the CLAAS AcuFORM system’s global opportunity. Leveraging Europe’s diverse healthcare systems and clinical networks, this trial phase intends to generate robust real-world evidence, drive physician adoption, and lay a strong foundation for future commercialization.

“Partnerships with European centers strengthen our global presence, accelerate innovation, and position us to deliver the benefits of our differentiated technology to patients worldwide,” Conformal Medical President/CEO James Reinstein said. “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.”

The CONFORM pivotal trial is a prospective, multicenter, randomized controlled study evaluating the safety and efficacy of the Conformal CLAAS AcuFORM System compared to other commercially available left atrial appendage (LAA) devices. The trial plans to randomize approximately 1,600 patients at sites worldwide and is now more than 30% enrolled. It aims to generate pivotal data supporting next-generation stroke prevention therapies for individuals with non-valvular atrial fibrillation (AFib) who are seeking an alternative to long-term oral anticoagulation.

Conformal Medical, Inc. is a medical device company developing devices to prevent stroke in patients with non-valvular atrial fibrillation. The company’s proprietary technology is intended to make left atrial appendage closure a same-day, single-operator procedure. The Conformal CLAAS AcuFORM system is lmited by U.S. law to investigational use and is not approved for commercial sale.