Conformal Medical announced “encouraging” results when comparing its CLAAS implant to the Boston Scientific Watchman FLX.
These left atrial appendage occlusion (LAAO) devices bring different things to the table. Made of foam, CLAAS features a cup design with an embedded nitinol skeleton covered by a fluoropolymer (ePTFE) cover. Watchman FLX’s nitinol frame is covered by a polyethylene terephthalate (PET).
Dr. William Gray presented an abstract on the comparison between devices at the Cardiovascular Research Technologies (CRT) 2024 conference.
The in vitro study compared the relative thrombogenicity of CLAAS compared to Watchman FLX. Investigators inserted three of each device into an acute radiolabeled in vitro blood loop system. After 90-120 minutes of exposure, investigators visually assessed the implants and measured the radiolabels.
Conformal Medical reported that CLAAS demonstrated incomplete coverage with “seemingly thinner thrombus.” The company saw 44% lower platelet deposition as well.
“These results are very encouraging, indicating the CLAAS implant appeared less thrombotic than the Watchman FLX in this in vitro blood loop model,” said Dr. Gray. “Device-related thrombus (DRT) remains a concern in left atrial appendage closure and advances in device design may help mitigate this in the clinical setting. The ePTFE fluoropolymer component in the CLAAS device appears to be less thrombogenic which may reduce DRT; still, more studies are required to further validate these initial results.”
Conformal Medical continues to actively enroll patients in its CONFORM pivotal trial. The trial evaluates CLAAS’s safety and efficacy against other commercially available LAAO devices. It expects to enroll approximately 1,600 subjects.