Earlier this year Loma Vista Medical gained CE mark for its TRUE Dilatation™ Balloon Valvuloplasty Catheter. Now the Californian outfit has received FDA clearance for what it claims is a product head and shoulders above the competition in balloon aortic valvuloplasty.
In case you don’t know the company, Loma Vista Medical is headquartered in Silicon Valley and dedicates itself to developing the world’s highest performing balloons for Balloon Aortic Valvuloplasty (BAV) and Transcatheter Aortic Valve Implantation (TAVI). The company says its mission is to commercialise products that are an indispensible part of every procedure by creating technology specifically designed to address the clinical challenges of BAV and TAVI.
Fabricated from tough, high-strength materials and featuring a rip-stop construction, the TRUE Dilatation device is designed to prevent the catastrophic failures seen with other heart valve dilatation balloons. As if to confirm that need, the company quotes studies, funded by the U.S. National Heart, Lung and Blood Institute (NHBLI) and others, which have reported up to a 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 Prof. Axel Linke,
M.D., 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.”
‘‘Our TRUE Dilatation Balloon represents a new paradigm in valvuloplasty and heart valve prep for TAVI. It clearly comes at a time when heart valve companies need a reliable, high performance balloon,’’ added Alex Tilson, founder and CEO of Loma Vista Medical. ‘‘Our TRUE Dilatation Balloon is designed to be both precise and tough, thereby facilitating exact, controlled and dependable dilatations for BAV and TAVI procedures. Our balloon also has additional important features——fast inflation and deflation——to improve balloon stability while reducing ‘rapid pacing’ time. This is critical: ‘rapid pacing’ is typically used by physicians to stabilize balloon dilatation, but it puts additional stress on a weak heart. Consequently our TRUE Dilatation Balloon is extremely important for treatment of the elderly patients undergoing BAV and TAVI. We are pleased to have an innovative product – CE marked and adopted by over 50 of Europe’s top TAVI centers – now also cleared for use in the United States.’’
Source: Loma Vista Medical