Manufacturers of left atrial appendage occlusion (LAAO) devices could have new competition in the not-too-distant future. Conformal Medical just launched a pivotal trial to evaluate its CLAAS System compared to commercially available LAAO devices to support FDA approval.
The prospective, multicenter, randomized controlled study will enroll about 1,600 patients in the U.S., Canada, and Japan. The Nashua, NH-based company said 75 patients have already been successfully implanted with the CLAAS System as part of early feasibility studies.
"Based on our experience in the early feasibility study, the CLAAS System is highly conformable to accommodate different anatomies," said Shephal Doshi, MD, executive director of the Heart & Vascular Institute, Prov. St. Johns Health Center & Cardiac Electrophysiology at the Pacific Heart Institute in Santa Monica, CA. "The study is designed to demonstrate the benefits of this technology for both implanting physicians and patients."
The CLAAS System is designed to seal the left atrial appendage in patients with non-valvular atrial fibrillation to reduce the risk of stroke without the need for anticoagulants. Featuring a foam-based architecture, the implant is designed to address a wide spectrum of LAA anatomies with only two sizes. The system aims to simplify delivery and eliminate the need for procedural transesophageal echocardiogram so that physicians may perform the procedure without general anesthesia, a significant advancement with the potential to shift clinical practice to a same day, single operator procedure.
"In this study, we will be evaluating the novel foam-based design of the CLAAS implant against the existing FDA-approved devices to evaluate performance on several metrics, including procedural safety, completeness of seal, and incidence of device-related thrombus," said William Gray, MD, system chief for cardiovascular diseases at Main Line Health and a professor at Lankenau Institute for Medical Research.
Andy Levine, president and CEO at Conformal Medical, said the investigational device exemption study includes the rigor of both a randomized study comparing CLAAS to commercial devices, and a separate sub-study designed to support a conscious sedation, ICE-driven approach.