Loma Vista Medical's True Dilatation Balloon Valvuloplasty catheter has received CE mark approval.

True Dilatation Balloon catheter is designed to prevent catastrophic failures seen with conventional heart valve dilatation balloons used in balloon aortic valvuloplasty (BAV) and transcatheter aortic valve implantation (TAVI) procedures.

German University Hospital Heart Center interventional cardiologist Axel Linke said, "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."

Loma Vista Medical founder and CEO Alex Tilson said the company is dedicated to treat elderly patients undergoing BAV and TAVI by developing TAVI tools that improve reliability and safety and enable physicians to reduce rapid pacing.

"The TRUE Dilatation Balloon is designed to do exactly that; it represents a new paradigm in percutaneous heart valve prep and valvuloplasty," Tilson added.

"And our next-generation product will take reliability, precision, and cardiac protection to the next level."