Silicon Valley-based medical device maker Loma Vista Medical received an FDA nod for its TRUE Dilatation Balloon Valvuloplasty Catheter, which the company says is designed to prevent the "catastrophic failures" seen with competing devices.
The TRUE devices is highly resistant to ruptures, punctures, and tears to prevent the heart valve dilatation balloons, according to Loma Vista.
Studies funded by the U.S. National Heart, Lung & Blood Institute found failure rates up to 17% among conventional balloons used in balloon aortic valvuloplasty and transcatheter aortic valve implantation procedures, according to the press release.
“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,” Alex Tilson, founder & CEO, said in prepared remarks.
“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,” Tilson added.
The TRUE Dilatation balloon valvuloplasty catheter won the CE mark approval in May. The product will be introduced at the ‘Transcatheter Cardiovascular Therapies 2012’ congress in Miami beginning Oct. 22, according to Loma Vista.