Minneapolis-based InterValve Inc. won FDA clearance for its V8 aortic valvuloplasty balloon catheter, which features a "figure-8" shape that helps lock the device in place in the aorta, the company announced.
The FDA okay-ed the device for stand-alone balloon aortic valvuloplasty as well as for pre-dilation during transcatheter aortic valve implantation procedures, according to a press release.
"These procedures are limited today by the use of dated, conventional balloon technologies," CEO Mark Ungs said in prepared remarks. "The shape and material properties of the V8 balloon catheter are designed to enhance both procedures through reduction in balloon movement and optimized leaflet expansion without over distention of the annulus."
The device’s shape may help reduce balloon movement during dilation, and could help reduce procedure time, according to the early-stage company.
