Loma Vista Medical has announced that it has received CE mark for its True Dilatation Balloon Valvuloplasty Catheter and will be launching its initial product at EuroPCR (Paris, France, 15–18 May 2012).
Fabricated from tough, high-strength materials and designed to prevent the catastrophic failures seen with other heart valve dilatation balloons, the True Dilatation Balloon is highly resistant to ruptures, punctures, and tears, according to a company release. Studies funded by the US National Heart, Lung and Blood Institute (NHBLI) and others have reported a 10% to 17% failure rate in conventional balloons used in BAV (balloon aortic valvuloplasty) and TAVI (transcatheter aortic valve implantation) procedures.
“The most important benefit of the True Dilatation Balloon is dependability,” said Axel Linke, an interventional cardiologist at The Heart Center, University Hospital, Leipzig, Germany. “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.”
“It is clearly established that heart valve companies need a consistently dependable balloon for valve dilatation in TAVI,” said Alex Tilson, founder and CEO, Loma Vista Medical. “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. The True Dilatation Balloon is especially important for treatment of the extremely sick, elderly patients undergoing BAV and TAVI.
The True Dilatation Balloon Valvuloplasty Catheteris not available for sale in the United States.