Conformal Medical to Present One-Year Data from its Left Atrial Appendage Occlusion (LAAO) Early Feasibility Study at TCT 2023

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Oct 19, 2023, 08:00 ET

The CLAAS^® System to be highlighted daily at TCT, including a live case presentation by Dr. Shephal Doshi

NASHUA, N.H., Oct. 19, 2023 /PRNewswire/ -- Conformal Medical, Inc. announced today the one-year results from the company's CONFORMAL Early Feasibility Study (EFS) will be presented during the 2023 Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco, CA. Dr. William Gray, System Chief, Cardiovascular Diseases at Main Line Health and professor at Lankenau Institute for Medical Research will present, "Conformal CLAAS LAAO Device EFS 1-Year TEE Follow Up" during a moderated abstract session.

Conformal Medical's CLAAS® Implant (PRNewsfoto/Conformal Medical, Inc.)

"I look forward to presenting the much anticipated one-year TEE follow up data from our initial clinical experience," stated Dr. Gray. "LAAO has emerged as an important alternative to anticoagulants for patients with atrial fibrillation who are at an increased risk of stroke and the CLAAS device has several compelling design advantages that may prove helpful in treating these patients."

The multi-center, single-arm feasibility study investigated the safety and performance of the CLAAS System and included TEE performed intra-procedurally, at 45 days and one year following implantation. The novel implant is designed to seal the LAA in patients with non-valvular atrial fibrillation (Afib) to reduce the risk of stroke without the need for anticoagulants. Featuring a proprietary foam-based architecture, the CLAAS implant addresses a wide spectrum of LAA anatomies with only two sizes, while simplifying device delivery and streamlining the procedure.

"We are extremely pleased to have the one-year Conformal EFS data presented at this year's TCT conference," commented James Reinstein, CEO of Conformal Medical. "We look forward to sharing the positive findings of the CLAAS System and continuing to build a robust body of evidence supporting this next-generation technology for patients suffering from atrial fibrillation and at an increased risk of stroke."

Conformal Medical is currently enrolling patients in its CONFORM Pivotal Trial to support U.S. commercialization.

Conformal Medical at Transcatheter Cardiovascular Therapeutics (TCT) 2023

Tuesday, October 24^th - Dr. William Gray will present, "Conformal CLAAS LAAO Device EFS 1-Year TEE Follow Up" during the Imaging in LAA Occlusion Procedures moderated abstract session at 10am PT in Hall A South.

Wednesday, October 25^th - Conformal Medical to host a breakfast symposium, "CLAAS Act: Conformal Medical Overview and CONFORM Trial Update" at 6:30am PT in Presentation Theater 1.

Thursday, October 26^th - Dr. Shephal Doshi, Executive Director, Heart & Vascular Institute, Providence St. John's Health Center & Cardiac Electrophysiology at the Pacific Heart Institute, will perform a live case presentation with the CLAAS System at 11:45am in the Structural Theater, Hall F North.

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 LAAO 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 associated risk of bleeding. 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

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.