A preclinical study demonstrating key features of the foam-based left atrial appendage closure device (CLAAS, Conformal Medical) has been published in the Journal of the Society for Cardiovascular Angiography and Interventions (JSCAI).
“This study validates the design features of Conformal’s CLAAS foam-based implant that enable it to fill in gaps and definitively seal, regardless of the left atrial appendage (LAA) shape,” stated William Gray (Lankenau Heart Institute, Wynnewood, USA) of the study, which offered insights into the ability of the device to position, deploy and seal the LAA, with appropriate healing at 150 days in a healthy canine model.
The CLAAS system is designed to seal the LAA in patients with non-valvular atrial fibrillation (AF) to reduce the risk of stroke without the need for anticoagulants. Featuring a proprietary foam-based architecture, the CLAAS implant is designed to conform to a broad range of LAA anatomies with only two sizes and aims to simplify the procedure by allowing off-axis positioning while providing a more uniform seal.
The implant also aims to eliminate the need for procedural transoesophageal echocardiogram so that physicians may perform the procedure without general anaesthesia, a significant advancement with the potential to shift clinical practice to a single operator procedure performed under conscious sedation without general anaesthesia.
“We are pleased to have these data published, demonstrating the ability of the CLAAS implant to successfully close the LAA in a healthy canine model with normal local healing without signs of device related thrombus, thrombus embolization, infection, or toxicity,” commented Aaron Kaplan, co-founder and chief medical officer for Conformal Medical. “We look forward to further validating its performance in the clinic as we accelerate enrolment in the CONFORM pivotal trial.”
Conformal Medical is actively enrolling patients in the CONFORM pivotal trial, evaluating the safety and efficacy of the CLAAS system compared to other commercially available LAAO devices. The prospective, multicentre, randomised controlled study will enroll approximately 1,600 patients in the USA and Japan and will support US Food and Drug Administration (FDA) premarket approval.