Conformal Medical has announced the enrolment of its 500th patient in the CONFORM investigational device exemption (IDE) trial, the prospective, multicentre, randomised controlled study evaluating the safety and efficacy of the Conformal CLAAS AcuFORM system compared to other commercially available left atrial appendage (LAA) devices.
This marks a significant milestone in the, reaching close to a third of the intended enrolment of 1,600 patients, and is a major step forward in validating the CLAAS System for patients with non-valvular atrial fibrillation (NVAF), Conformal Medical says in a press release.
Christopher Ellis (Vanderbilt Health Nashville, Nashville, USA), Vikrant Jagadeesan (West Virginia University, Morgantown, USA) and Devi Nair (St Bernards Medical Center and White River Medical Center, Jonesboro, USA) were among the first operators to implant the next-generation CLAAS AcuFORM left atrial appendage occlusion (LAAO) device.
The CLAAS system aims to provide an alternative option to seal the LAA with only two sizes, to reduce stroke risk without needing long-term anticoagulant therapy.
“I am pleased with the performance of the next-gen CLAAS AcuFORM system. Enhancements to the delivery system and the implant, combined with the addition of a steerable sheath, have improved the performance and ease of use,” said Nair. “I believe this system has the potential to be a meaningful advancement and I look forward to validating this as we continue enrollment for the CONFORM trial.”
Additionally, Conformal confirms that the next-generation CLAAS AcuFORM device has been implanted in 51 patients worldwide. The device is designed to naturally conform to the LAA instead of reshaping it, as seen with commercially available devices.
The CLAAS AcuFORM implant features a self-expanding nitinol endoskeleton for flexibility and an adaptive foam matrix.
“Reaching the 500th patient enrolment in the CONFORM IDE trial is a testament to the dedication of the Conformal team and the trust our implanting physicians place in our technology,” commented James Reinstein, president and CEO of Conformal Medical. “We are committed to advancing stroke prevention technology and look forward to delivering the CLAAS AcuFORM system to market in the coming years.”
