The Conformal Medical CLAAS® AcuFORM™ Left Atrial Appendage Occlusion (LAAO) System to be Prominently Featured at TCT 2024

Next-generation system to be highlighted during a technology innovation session and live case presentation by Professor Jens Erik Nielsen-Kudsk

NASHUA, N.H., Oct. 22, 2024 /PRNewswire/ -- Conformal Medical, Inc. announced today, the next-generation CLAAS® AcuFORM™ Left Atrial Appendage Occlusion (LAAO) System will be highlighted during the 2024 Transcatheter Cardiovascular Therapeutics (TCT) conference in Washington, DC, October 27-30th.

“With a single size, the CLAAS® AcuFORM™ implant can treat over 90% of patients.”

“We are pleased that the CLAAS AcuFORM system is included on the agenda for this year’s meeting and for the opportunity to showcase its differentiated implant design,” commented Dr. Aaron Kaplan, co-founder and Chief Medical Officer for Conformal Medical. “With a single size, the CLAAS AcuFORM implant can treat over 90% of patients. Additionally, with its unique construction, the implanter can accurately assess the LAA seal with angiography. We expect the CLAAS AcuFORM device will eventually enable the adoption of Intracardiac Echocardiography (ICE) imaging.”

ICE does not require general anesthesia reducing the need for additional healthcare personnel to complete the procedure. These improvements in operational efficiency will enable continued growth of the LAAO market.

Over 350 successful implants with the Conformal CLAAS® System have been performed in patients participating in the Conformal early feasibility studies, the CONFORM Pivotal Trial and the newly initiated European GLACE-ICE Conscious Sedation Study.

Conformal Medical at Transcatheter Cardiovascular Therapeutics (TCT) 2024:

Monday, October 28th - Professor Jens Erik Nielsen-Kudsk, M.D. of Aarhaus University Hospital in Denmark will review a live case presentation with the CLAAS® AcuFORM™ LAAO System at 11:50am during the LAAO III: Evidence Gaps, Expanded Use Trends, and Future Directions session in the Structural Spotlight Room, Convention Center Level 2.

Wednesday, October 30th - William A. Gray, M.D. co-Director of the Lankenau Heart Institute at Main Line Health will present, “The Next-Generation CLAAS® AcuFORM™ LAAO Technology: Program Update” during the TCT Innovation 16: Innovations in LAAO Technologies session at 9:50am in the Innovation Theater, Convention Center Lower Level.

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 with associated bleeding risk. 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

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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 2024.

3. Boston Scientific Investor Update, September 2023.

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SOURCE Conformal Medical, Inc.

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