CONFORMAL EFS study results presented at CRT 2023

Conformal Medical’s CLAAS implant

Results from the CONFORMAL early feasibility study (EFS), evaluating the use of angiography compared to transoesophageal echocardiogram (TEE) for left atrial appendage (LAA) assessment have been presented at the 2023 Cardiovascular Research Technologies (CRT) conference (25–28 February, Washington DC, USA).

William Gray, co-director of the Lankenau Heart Institute and professor of medicine at Thomas Jefferson University (Philadelphia, USA) during the Left Atrial Appendage Closure Forum at CRT.

“This study evaluated baseline TEE and angiographic data collected from 36 atrial fibrillation (AF) patients who were deemed appropriate for left atrial appendage occlusion (LAAO),” stated Gray. “The complete paired images were analysed for LAA diameter and depth to facilitate CLAAS device size selection. Results demonstrated a 97% agreement in device size selection between the two imaging modalities.”

The CLAAS system is designed to seal the LAA in patients with non-valvular AF 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 TEE so that physicians may perform the procedure without general anaesthesia, a significant advancement with the potential to shift clinical practice to a same day, single operator procedure.

“The novel CLAAS device is designed to streamline LAAO procedures,” commented Aaron Kaplan, professor of medicine at Dartmouth and co-founder and chief medical officer for Conformal Medical. “This study demonstrates that with only two sizes, the CLAAS implant requires minimal imaging, an important step as we look to transform the procedure to a single operator, same day procedure.”

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 enrol approximately 1,600 patients in the USA and will support US Food and Drug Administration (FDA) premarket approval.


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