Direct Flow Medical today announced the European launch of its next-gen DirecTrack Delivery System designed for its Direct Flow transcatheter aortic valve system.
The new system features improved ergonomics and functionality for greater control during the implantation procedure, the Santa Rosa, Calif.-based company said.
“We’re pleased to provide physicians with this latest advance in TAVI procedural control. The DirecTrack Delivery System provides all the features of our prior delivery system but with significantly enhanced ergonomics and precision to assure the best possible clinical outcome,” CEO Dan Lemaitre said in a press release.
Direct Flow said its TAVI device features a metal-free frame and a low-profile delivery system, as well as a double-ring design that is both repositionable and retrievable after full deployment.
“I have had the opportunity to use every generation of the Direct Flow Medical delivery system since its inception. The new DirecTrack system is a major step forward in positioning control and smooth valve delivery. I’m impressed with the additional procedural efficiency gained, making it faster and easier to achieve an optimal outcome,” Dr. Joachim Schofer of Hamburg, Germany’s Hamburg University Cardiovascular Center said in prepared remarks.
Last month, Direct Flow premiered its transcatheter mitral valve, developed as part of its TMV development program. The debut was made at the 2nd annual Zurich Heart Team Mitral Valve meeting.
The valve is designed to be repositionable and retrievable, and is built upon Direct Flow’s transcatheter aortic valve, the company said.
The new device’s mitral-specific valve design features a low atrial profile, low ventricular projection and sealing and fixation rings for the complex mitral annulus, the company said.