#United States #Boston #AF Symposium #Conformal Medical #CLAAS AcuFORM

Conformal Medical Showcases GLACE Study Results at AF Symposium

Conformal Medical, Inc. recently made headlines by announcing that early findings from its GLACE Study will be showcased at the coveted Annual AF Symposium scheduled in Boston, MA, on January 17, 2025. This presentation will spotlight the initial clinical application of the groundbreaking CLAAS® AcuFORM™ Left Atrial Appendage Occlusion (LAAO) device, a part of a pioneering multicenter, single-arm European study. The importance of this study is underscored by its evaluation of the device's performance through Intracardiac Echocardiography (ICE) imaging, which allows LAAO treatment to be administered without the need for general anesthesia.

Dr. Shephal Doshi, the Principal Investigator of the CONFORM Pivotal Trial and a leading cardiologist at Providence Saint John's Health Center and the Pacific Heart Institute in California, expressed excitement regarding the initial patient experiences using the AcuFORM device. He remarked, "The unique foam construction facilitates immediate assessment of the seal under ICE guidance, a significant advancement for patient comfort and operational efficiency." The impressive results further validate the ease of use and sizing of the device, with nearly all treated patients using a regular-size model, akin to observations from prior studies.

In addition to the promising findings presented, Conformal Medical revealed that over 30 patients globally have already received treatment using the CLAAS AcuFORM LAAO device in both the CONFORM IDE Trial and the European GLACE Study. The latest device boasts an efficient delivery system while retaining the ease of sizing and sealing established by its predecessor. This innovation provides patients and healthcare providers with a compelling method to seal the left atrial appendage, mitigating stroke risk while eliminating the reliance on long-term anticoagulant therapy.

James Reinstein, President and CEO of Conformal Medical, highlighted the significance of patient enrollment in the GLACE Trial, viewing it as a crucial milestone. He stated, "Our aim is to offer physicians and patients new and revolutionary alternatives to the current treatment methods available for LAAO." To date, more than 420 patients have been successfully randomized in the CONFORM Pivotal Trial, and there is optimism about further advancements with the CLAAS AcuFORM system in both trials moving forward.

Conformal Medical is dedicated to preventing strokes in patients dealing with non-valvular atrial fibrillation, a condition that currently impacts more than six million individuals in the U.S. alone. The traditional standard of care involves the use of chronic oral anticoagulants, often unappealing to patients due to the associated bleeding risks. By providing an innovative solution like Left Atrial Appendage Occlusion (LAAO), Conformal Medical is at the forefront of a promising alternative that is expected to revolutionize stroke prevention strategies for the millions living with atrial fibrillation.

As the global market for first-generation LAAO devices reached an estimated $1.4 billion in 2023, projections suggest it could expand to over $6 billion by 2030. Conformal Medical’s commitment to delivering innovative solutions is evident, and the CLAAS System stands as a testament to their mission, promising safer and more effective options for patients and clinicians alike while adhering to investigational use regulations.

For further information about Conformal Medical and their innovative approaches to stroke prevention, visit their official website at conformalmedical.com.