The US Food and Drug Administration (FDA) has cleared Loma Vista Medical's TRUE Dilatation Balloon Valvuloplasty catheter, designed to prevent balloon ruptures in balloon aortic valvuloplasty (BAV) and transcatheter aortic valve implantation (TAVI) procedures.
The CE-marked dilatation catheter, which is fabricated using tough, high-strength materials, is resistant to ruptures, punctures, and tears caused by conventional balloons.
Loma Vista Medical founder and CEO Alex Tilson said the 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," Tilson added.
"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."
The company said the dilatation catheter will be featured at Transcatheter Cardiovascular Therapies (TCT) 2012 congress in Miami, Florida, US.