Medical Device Daily Staff Writer

Loma Vista Medical (Burlingame, California) has developed an application that it claims is tough enough to endure TAVI procedures. The company gained FDA clearance for its TRUE Dilatation Balloon Valvuloplasty catheter, a device that's been fabricated from tough, high-strength materials and designed to prevent the catastrophic failures seen with other heart valve dilatation balloons.

In essence, the device 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.

"We make the world's most advanced medical balloons with a flexible composite platform," Alex Tilson founder and CEO of Loma Vista Medical told Medical Device Daily. "Where as most medical balloons are made with one material and one layer, essentially we have seven materials and seven layers. So we can do things with composites that you can't do any other way. Part of our thesis is all the world's best structures are composites . . . we believe that in the future that all medical balloons will be composites."

The TRUE Dilatation Balloon is designed to be both precise and tough, thereby facilitating exact, controlled and dependable dilations for BAV and TAVI procedures. According to the company, the device also has additional important features – fast inflation and deflation – to improve balloon stability while reducing 'rapid pacing' time.

The company says 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 firm said that the TRUE Dilatation Balloon Catheter inflates and deflates two to three times faster than competitors' balloons, minimizing ischemia time.

"The point of [the quick inflation and deflation] is when you're trying to inflate the balloon in the aortic valve, you are actually stopping all blood flow," Maurice Buchbinder, MD, Medical Director of the Foundation for Cardiovascular Medicine (San Diego) told MDD. "You try to do it as quickly as possible so as to not interfere [too much from the blood flow]."

It's a point that the firm said is critical: and that this 'rapid pacing', which is typically used by physicians to stabilize balloon dilatation puts additional stress on a weak heart. Consequently the TRUE Dilatation Balloon is extremely important for treatment of the elderly patients undergoing BAV and TAVI.

"We've got about 30 times less stretch than other balloons out there so no matter, we're always the same in contrast to curve balloons which have wide variability in them due to inflation and those balloons stretch," Tilson said. "It's important because TAVI balloons have some of the highest structure failure rates as any balloons in any medical application."

In addition to FDA clearance the device is CE marked and has been adopted by more than 50 of Europe's TAVI centers (Medical Device Daily, May 14, 2012). Since the device received CE mark it has been used in more than 1,000 cases in Europe according to Tilson.

"The most important benefit of the TRUE Dilatation Balloon is dependability," said Axel Linke, MD, an interventional cardiologist at The Heart Center – University Hospital (Leipzig, Germany) in a May 14 statement regarding the device getting approval in Europe. "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."

Omar Ford, 404-262-5546;

omar.ford@ahcmedia.com

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