Corvention earns FDA clearance for aortic valve balloon catheter

Corvention announced today that it received FDA 510(k) clearance for its KardiaPSI balloon catheter device.

Flagstaff, Arizona-based Corvention’s device is indicated for balloon aortic valvuloplasty (BAV). The company says it provides interventionalists with an ultra-high-pressure solution for the precise dilation of stenotic aortic valves.

Corvention designed KardiaPSI to address the mechanical challenges of calcified valve anatomy. It delivers high-pressure dilation with controlled expansion and a short footprint for more predictability and accuracy during valvuloplasty procedures.

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