Conformal Medical’s Pivotal Trial of CLAAS AcuForm LAAO Device Begins European Enrollment

October 15, 2025—Conformal Medical Inc. announced the initiation of European Union patient enrollment in the CONFORM pivotal trial, which is evaluating the safety and efficacy of the company’s CLAAS AcuForm left atrial appendage occlusion (LAAO) device.

Conformal Medical stated that the CLAAS AcuForm system is a foam-based implant designed to simplify stroke prevention procedures for patients with nonvalvular atrial fibrillation (AFib). The device is intended to conform to individual left atrial appendage anatomies and aims to reduce procedural complexity while improving seal reliability.

According to the company, CONFORM is a multicenter, randomized controlled study comparing the CLAAS AcuForm system with other commercially available LAAO devices. The study plans to enroll approximately 1,600 patients globally and is currently more than 30% enrolled. The launch of the trial was announced in June 2022.

The data generated will support regulatory submissions for next-generation stroke prevention therapies intended for patients with nonvalvular AFib seeking alternatives to long-term oral anticoagulation, advised Conformal Medical.

The first procedure in Europe was performed by Philippe Garot, MD, Head of Interventional Cardiology at Institut Cardiovasculaire Paris Sud in Massy, France.

“The CLAAS AcuForm system represents an important innovation in LAAO, with the potential to simplify procedures, expand access, and improve outcomes for patients with nonvalvular AFib,” commented Dr. Garot in the company’s press release. “We are excited to participate in the CONFORM pivotal trial and to help bring this next-generation therapy to patients across Europe.”

Conformal Medical noted that the expansion of the CONFORM trial into the European Union is a milestone for the company as it scales its global clinical program with participation by leading centers in the European Union that will help generate real-world data and support future commercialization efforts under the European Union Medical Device Regulation.