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. Studies funded by the U.S. National Heart, Lung and Blood Institute (NHBLI) and others have reported up to a 17% failure rate in conventional balloons used in BAV (balloon aortic valvuloplasty) and TAVI (transcatheter aortic valve implantation) procedures.
“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 inn ovative product - CE marked and adopted by over 50 of Europe’s top TAVI centers - now also cleared for use in the United States.”
About Loma Vista Medical
Headquartered in Silicon Valley (Burlingame, Calif.), Loma Vista Medical is a venture capital-funded medical device company dedicated to developing the world’s highest performing balloons for Balloon Aortic Valvuloplasty (BAV) and Transcatheter Aortic Valve Implantation (TAVI). The company’s mission is to commercialize products that are an indispensible part of every procedure by creating technology specifically designed to address the clinical challenges of BAV and TAVI.