Conformal Medical, Inc. announced today the presentation of the first left atrial appendage closure (LAAC) cases with its unique CLAAS® Technology in patients under conscious sedation without general anesthesia.
Drs. Petr Neuzil and Vivek Reddy will present “ICE-Guided Implantation of the Conformal Left Atrial Appendage Closure Device: First Clinical Report” at the AF Symposium meeting in Washington, D.C., January 23-24.
LAAC is an emerging therapy to prevent strokes in patients with atrial fibrillation (AFib). The Conformal CLAAS Implant has a unique foam-based architecture designed for simpler delivery in patients under conscious sedation utilizing fluoroscopy and Intracardiac Echo (ICE) eliminating the need for Transesophageal Echo (TEE) and obligatory general anesthesia. These first procedures using the conscious sedation protocol were successfully performed at Homolka Hospital in Prague, Czech Republic.
“The ability to use ICE imaging streamlines the LAAC procedure by providing the required imaging without the need for TEE and general anesthesia,” said Professor Neuzil, Department Head, Cardiology, Homolka Hospital. “In the eight cases we performed at Homolka Hospital, we achieved successful closure with one size device, significantly streamlining the procedures.”
Over six million people in the United States suffer from AFib, putting them at increased risk of stroke. The current standard of care for stroke prevention is chronic use of oral anticoagulants, which are not well accepted by patients due to concern about associated bleeding. The left atrial appendage (LAA) is a pouch off the upper heart chamber where clots associated with stroke in AFib patients form. LAAC with the Conformal System eliminates the need for anticoagulation and is emerging as an alternative stroke prevention strategy. The LAA sealing procedure is performed minimally invasively from a small incision in the groin.
“These results validate the ability of Conformal’s CLAAS System to successfully close the LAA without the need for TEE and general anesthesia,” said Aaron V. Kaplan, MD, Professor of Medicine at Dartmouth and Co-Founder of Conformal Medical. “The initial 27 Conformal cases to date demonstrate the ability of Conformal’s two sizes to address a wide spectrum of LAA anatomies, which would have required 5-8 sizes with other devices. The Conformal System has the potential to make the LAAC procedure simpler to perform and more accessible to AFib patients at risk of stroke.”