Conformal Medical Announces GLACE Study to be Highlighted at AF Symposium

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Conformal Medical, Inc.

Jan 16, 2025, 08:03 ET

Abstract presentation will feature the first clinical use of the company's CLAAS® AcuFORM™ Left Atrial Appendage Occlusion (LAAO) Device

NASHUA, N.H., Jan. 16, 2025 /PRNewswire/ -- Conformal Medical, Inc., today announced that the early results of its GLACE Study will be presented during the Annual AF Symposium in Boston, MA on Friday, January 17th and will highlight the initial clinical use of the new CLAAS® AcuFORM™ device as part of the prospective, multicenter, single-arm European study. Notably, the study evaluates device performance under Intracardiac Echocardiography (ICE) imaging, allowing patients to receive left atrial appendage occlusion (LAAO) treatment without general anesthesia.

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"We are excited to share the initial case experience with the AcuFORM device. The unique foam construction allowed for immediate assessment of the seal under ICE guidance, a huge advancement with regards to both patient comfort and operational efficiency," stated Shephal Doshi, M.D., from Providence Saint John's Health Center and the Pacific Heart Institute in Santa Monica, California, and Principal Investigator of the CONFORM Pivotal Trial. "Furthermore, almost all the patients were successfully treated with the regular-size device, which is consistent with our experience in the CONFORM Trial and further validates the system's simplified sizing and ease of use. I am pleased with the performance in these cases and look forward to using the CLAAS AcuFORM device in the CONFORM Trial after these promising results."

Additionally, Conformal confirmed that over 30 patients worldwide have been treated with the new CLAAS AcuFORM LAAO device in the CONFORM IDE Trial and the European GLACE Study. The new device features an easy and simple delivery system and maintains the advantages in both sizing and sealing that were apparent in the first-generation device. The CLAAS® System offers patients and physicians an alternative option to seal the LAA and reduce stroke risk without the need for long-term anticoagulant therapy.

"Patient enrollment in the GLACE Trial with the CLAAS AcuFORM System is a significant milestone as we work to provide physicians and patients with a new disruptive alternative to current offerings," said James Reinstein, President and CEO of Conformal Medical. "Over 420 patients have been successfully randomized in the CONFORM Pivotal Trial to date. We look forward to offering patients the benefit of the CLAAS AcuFORM in both the CONFORM and GLACE Trials going forward."

About Conformal Medical
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. For more information, visit https://conformalmedical.com/.

About Left Atrial Appendage Closure
More than six million people in the United States suffer from Afib, placing them at an increased risk of stroke.1 Current standard of care for stroke prevention is chronic oral anticoagulants, which are not well accepted by patients due to concern about the associated risk of bleeding. Left Atrial Appendage Occlusion (LAAO) is emerging as an important alternative to blood thinners for preventing strokes in patients with non-valvular Afib. First-generation LAAO devices are an estimated $1.4B global market in 2023 and are expected to grow to over $6B by 2030.2,3

CAUTION: Investigational Device.
The CLAAS System is limited by Federal (or United States) law to investigational use.

  1. Kornej J, Börschel CS, Benjamin EJ, Schnabel RB. Epidemiology of Atrial Fibrillation in the 21st Century: Novel Methods and New Insights. Circ Res. 2020 Jun 19;127(1):4-20.
  2. Piper Sandler Market Analyst Report, September 2023.
  3. Boston Scientific Investor Update, September 2023.

SOURCE Conformal Medical, Inc.