Loma Vista Medical has received CE mark clearance for its True Dilatation balloon valvuloplasty catheter, indicated for preventing balloon ruptures in balloon aortic valvuloplasty (BAV) and transcatheter aortic valve implantation (TAVI) procedures.

Made from high-strength materials, the True Dilatation balloon valvuloplasty catheter is found to be resistant to ruptures, punctures and tears, compared to conventional balloons that reported a 10% to 17% failure rate.

University Hospital, Germany, Heart Center interventional cardiologist Axel Linke said: "In my experience, I believe that the True Dilatation Balloon is, by far, the most durable and most precise balloon available to pre-dilate a heart valve in preparation for a percutaneous implant and to dilate a heart valve with a valvuloplasty procedure."

"The True Dilatation balloon catheter is found to be resistant to ruptures, punctures and tears."

Loma Vista Medical founder and CEO Alex Tilson said the True Dilatation balloon is designed to be precise and tough, thus enabling accurate, controlled and reliable dilatations for BAV and TAVI procedures.

"The balloon also features fast inflation and deflation for reduced rapid pacing time. Rapid pacing is generally used by physicians to facilitate valvuloplasty, but it is known to put additional stress on a frail heart," Tilson added.

"The True Dilatation balloon is especially important for treatment of the extremely sick, elderly patients undergoing BAV and TAVI."

Currently, the True Dilatation balloon valvuloplasty catheter is not available for sale in the US, the company said.

Loma Vista Medical, headquartered in Silicon Valley, US, is a venture capital-funded medical device company focused on the development of balloons for performing BAV and TAVI procedures.