Patent Portfolio Growing For Direct Flow Medical’s Innovative TAVI System

In short

Direct Flow Medical®, Inc., a transcatheter heart valve innovator focused on improving patient outcomes, has announced it has been awarded U.S. Patent No. 8,377,118 by the U.S. Patent and Trademark Office (USPTO) and Japanese Patent No. 5,119,148 by the Japan Patent Office.


We’ve covered Direct Flow’s TAVI offering before, most recently in January, here, when the product gained CE mark approval.  The company’s proprietary technology encompasses a distinctive transcatheter aortic heart valve with a metal-free frame and flexible, low-profile delivery system that it says virtually eliminates aortic regurgitation.

It’s well established by now that post-procedural aortic regurgitation has been shown to be a predictor of long-term mortality. Direct Flow Medical’s system is designed to address this clinical concern by allowing complete assessment of hemodynamic performance, repositioning and retrieval after the valve is fully deployed in the native valve annulus. It’s a clever design and definitely breaks the mold when it comes to this new generation of minimally invasively implanted aortic valves.

With the new patent grants the Company now has 13 issued U.S. patents and 24 additional patent applications filed in the U.S. or under the Patent Cooperation Treaty.

Company comments

“Our unique solution to the major clinical issues associated with transcatheter aortic valve replacement (TAVR) has enabled us to build an impressive intellectual property portfolio,” said Gordon Bishop, Direct Flow Medical’s Chief Technology Officer, co-founder and inventor of the two recently awarded patents. “With issued U.S. and foreign patents, our intellectual property portfolio has global breadth, and we intend to continue to expand it as we develop and refine additional technologies.”

Regulatory status

The Direct Flow Medical® Transcatheter Aortic Valve System is CE marked, but has not been approved for use in the U.S., Canada or Japan.

Source: Direct Flow Medical, Inc.