- Direct flow medical, inc. completes enrollment in u.s. salus feasibility trial of transcatheter aortic heart valve system
- Direct flow medical, inc. receives ce mark for first fully repositionable 29 mm transcatheter aortic valve system
- Direct flow medical transcatheter aortic valve system continues to demonstrate excellent outcomes at six months in discover ce mark trial
Direct Flow Medical – Transcatheter Aortic Valve System
The Direct Flow Medical system is designed to treat aortic stenosis with minimal risk of aortic regurgitation, a significant clinical complication with current transcatheter aortic heart valve replacement (TAVR) systems. By reducing the risks of TAVR, the Direct Flow Medical system is designed to improve the long-term outcomes of patients undergoing this procedure.
The system’s unique design encompasses a distinctive metal-free valve frame and flexible, low-profile delivery system, which enables limitless repositionability and repeated assessment of full hemodynamic performance before final implantation.
- Learn more about what our technology can offer your TAVR program
- Think Big: Introducing the First Fully Repositionable 29mm Transcatheter Aortic Valve.
- The Direct Flow Medical Transcatheter Aortic Valve System received CE Mark approval in 2013.
- The Direct Flow Medical product meets the essential requirements of the Medical Device Directive 93/42/EEC for CE marking of conformity
- and is available commercially on the European market.
- Refer to Instructions for Use for a complete list of warnings, precautions and contraindications.
CAUTION: The Direct Flow Medical Transcatheter Aortic Valve System has not been approved for use in the USA, Canada, or Japan.
Direct Flow Medical and the Direct Flow logo are trademarks of Direct Flow Medical, Inc. Copyright © 2013 Direct Flow Medical, Inc. All rights reserved