FDA clears True Dilatation Balloon Valvuloplasty Catheter


The US Food and Drug Administration (FDA) has given Loma Vista Medical clearance for its True Dilatation Balloon Valvuloplasty Catheter. The device, which is also CE-marked, features a balloon specifically designed to prevent balloon ruptures in transcatheter aortic valve implantation (TAVI) and balloon aortic valvuloplasty (BAV) procedures.

The True Dilatation Balloon Valvuloplasty Catheter  will be featured at the “Innovations Symposium” during the upcoming Transcatheter Cardiovascular Therapies (TCT) 2012 congress (Miami, USA, 22─27 October). It will also be presented during a Live Case from Ferrarotto Hospital in Catania, Italy, on Wednesday 24 October in the Transcatheter Valve Therapies II session.

“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 stabilise 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 centres now also cleared for use in the United States,” said Alex Tilson, founder and CEO of Loma Vista Medical.