W. L. Gore & Associates announced it has entered into a definitive agreement to acquire Conformal Medical, a medical device company developing the investigational CLAAS AcuFORM System, a next-generation left atrial appendage occlusion (LAAO) technology aimed at stroke prevention for patients with non-valvular atrial fibrillation. The transaction is expected to close in early 2026, subject to regulatory approval.
Gore said the acquisition adds the CLAAS AcuFORM technology to its endovascular portfolio and complements its existing cardiac products as the company looks to expand into adjacent endovascular treatments. The companies emphasized that the CLAAS AcuFORM System remains investigational and is not approved for commercial use.
Conformal’s device features a nitinol endoskeleton with a proprietary foam matrix implant designed to conform to a broader range of left atrial appendage anatomies with fewer sizes. Offered in two sizes, the system is intended to simplify procedures and has the potential to shift LAAO toward a same-day treatment model, moving practice away from general anesthesia and overnight hospital stays, according to the announcement. The device is currently in clinical testing.
LAAO is a one-time procedure intended to reduce the risk of stroke-causing blood clots by closing off the left atrial appendage, where clots can form in patients with non-valvular atrial fibrillation, and potentially eliminate the need for long-term daily oral anticoagulant therapy. The companies pointed to growing demand for stroke-prevention options, noting projections that atrial fibrillation could exceed 12 million cases in the U.S. by 2030.
Conformal said the combination pairs its expertise in LAAO with Gore’s capabilities in technology development, distribution and operations, and is intended to support the therapy through the clinical and regulatory process toward broader global availability.
BDT & MSD Partners is serving as Gore’s exclusive financial advisor and Davis Polk as legal counsel. Piper Sandler is serving as Conformal Medical’s exclusive financial advisor and Gunderson Dettmer as legal counsel.
KEY QUOTES:
“The investigational CLAAS AcuFORM System represents the kind of transformative, science-driven innovation that reflects our long-term commitment to improving patient care. It is an ideal fit with our endovascular portfolio and a strong complement to our existing cardiac products. As a privately held company founded on scientific innovation, Gore continues to thoughtfully pursue opportunities and partnerships that expand our ability to improve lives through the work of all our businesses, including expanding our ability to serve clinicians and improve patient outcomes.”
Bret Snyder, Board Chair and CEO, W. L. Gore & Associates
“We are pleased to join forces with a partner that reflects our belief that the investigational CLAAS AcuFORM Device can prove to be a transformative solution for stroke prevention. Our stakeholders will realize the value of this partnership as we bring this therapy through the clinical and regulatory process and eventually make it available to patients worldwide. This partnership combines Conformal’s deep expertise in LAAO with Gore’s world-class capabilities in technology development, distribution and operations. It will enable us to leverage Gore’s global presence, accelerating our mission of shaping the future of stroke prevention.”
James Reinstein, President and CEO, Conformal Medical
