Performing aortic valvuloplasties or implanting heart valve prostheses using transcatheter methods requires a good deal of force to be applied by a tiny balloon on the calcified valve. Balloons have been reported to sometimes break when coming in contact with the sharp and rigid calcified deposits on the valve, often causing serious issues.
Loma Vista Medical (Burlingame, CA) just received FDA clearance for its TRUE Dilatation Balloon Catheter that promises to withstand just about any aortic valve thrown at it while being inflated to pressures up to 6 atm/bar. The device has the European CE Mark and is in use in dozens of hospitals on the continent.
From the company:
“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.”
Fabricated from bulletproof materials, the TRUE Dilatation Balloon is highly resistant to ruptures, punctures, and tears. Rip-stop fibers prevent the catastrophic failures seen with other balloons. The TRUE Dilatation Balloon delivers the dependability you need.
Fiber reinforcement precisely limits the maximum balloon diameter to the labeled size, while allowing conformance to anatomical variation. Other valvuloplasty balloons change diameter by 15 to 40% over their rated pressure range. The TRUE Dilatation Balloon redefines the category, offering diameter control within 1.5%*.
The TRUE Dilatation Balloon Catheter inflates and deflates 2 to 3 times faster than competitors’ balloons*, minimizing ischemia time.”
Product page: TRUE Dilatation Balloon Catheter…
(hat tip: MassDevice)