Conformal Medical Begins Pivotal LAAO Trial

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Left atrial appendage closure is a well-validated treatment to prevent stroke in AFib patients, but current device options do not allow physicians to streamline their practices to their needs. Conformal Medical’s CLAAS device, now in a large, randomized pivotal trial, was created to address a market ripe with growth while supporting greater case volumes and safer outcomes.

Left atrial appendage occlusion (LAAO) is an area gaining strategic interest, with both Johnson & Johnson and Medtronic recently acquiring technologies in the category to compete with Boston Scientific’s majority share of the market. (See “J&J Strikes While the Iron Is Hot, Acquires Laminar,” MedTech Strategist, December 21, 2023.) The left atrial appendage is a critical structure in the early development of the heart, after which point it becomes a largely vestigial area where blood can pool and clot, potentially leading to a stroke. As such, LAAO is recommended for non-valvular atrial fibrillation patients at elevated risk of stroke as an alternative to long-term systemic anticoagulant therapy, though some applications such as Medtronic’s Penditure LAA clip are indicated for deployment during cardiac surgery. Several devices are in clinical testing currently, including Sepiola from Endomatic, and J&J’s purchase of Laminar on the basis of small clinical trials bodes well for a company like Conformal Medical, which is in the midst of a large-scale randomized pivotal study and now under the leadership of a seasoned medtech entrepreneur.


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