Conformal Medical's CLAAS Implant (PRNewsfoto/Conformal Medical, Inc.)
October 19, 2023 — 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.
"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 24th - 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 25th - 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 26th - 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.
For more information: https://conformalmedical.com/