Conformal Medical, Inc., a medical device company developing next-generation LAAO technology, the launch of the CONFORM pivotal trial with the enrollment of the first patients at two U.S. sites.
The investigational device exemption (IDE) study will evaluate the safety and efficacy of the company's CLAAS® System compared to commercially available LAAO devices to support U.S. Food and Drug Administration (FDA) pre-market approval.
The first patients were treated at their respective institutions by co-principal investigators of the trial, Dr. Shephal Doshi, Executive Director, Heart & Vascular Institute, Prov. St. Johns Health Center & Cardiac Electrophysiology at the Pacific Heart Institute in Santa Monica, CA and Dr. William Gray, System Chief, Cardiovascular Diseases at Main Line Health and professor at Lankenau Institute for Medical Research.
"I am excited to initiate this important trial and for the potential of this innovative technology to expand treatment options for patients with atrial fibrillation (Afib)," stated Dr. Gray.
"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."
The prospective, multicenter, randomized controlled study will enroll approximately 1,600 patients in the U.S., Canada, and Japan. To date, over 75 patients have been successfully implanted with the CLAAS System as part of the company's early feasibility studies.
"Based on our experience in the Early Feasibility Study, the CLAAS System is highly conformable to accommodate different anatomies," stated Dr. Doshi. "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 LAA in patients with non-valvular Afib to reduce the risk of stroke without the need for anticoagulants. Featuring a proprietary foam-based architecture, the implant addresses 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.
"We are pleased to enroll the first patients in the CONFORM trial, an important milestone for the company. Kicking off the study builds on the strong momentum from our EFS experience," commented Andy Levine, President and CEO of Conformal Medical.
"This IDE 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; a critical step towards our goal to transform LAAO and reduce the risk of stroke, without the need for anticoagulants."
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. 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 $700M global market in 2021 and are expected to grow to over $3B in the next five years.2,3