SANTA ROSA, Calif.--(BUSINESS WIRE)--Direct Flow Medical®, Inc., an innovative structural heart company, today announced the appointment of Mary Edwards as Vice President, Regulatory and Clinical Affairs. In her role, Ms. Edwards will oversee all global clinical and regulatory efforts, including administration of the company’s U.S. SALUS pivotal trial studying the Direct Flow Medical Transcatheter Aortic Valve System, as well as the DISCOVER post-market European study.
Ms. Edwards possesses more than 30 years of regulatory and clinical affairs experience in the medical device industry, including more than 20 years in the cardiovascular space. She has served as Global Vice President of Regulatory Affairs for Medtronic Vascular, where she was responsible for the filing and approval of five PMAs. As Vice President of Regulatory and Clinical Affairs for C.R. Bard, she spearheaded multiple PMA approvals and 510(k) clearances. She was also the original regulatory affairs professional for W.L. Gore & Associates, where she served for 15 years. Ms. Edwards earlier provided independent regulatory and clinical consulting for several firms, and has held senior regulatory and clinical affairs roles with several women’s health companies.
“We are delighted to have Mary Edwards join Direct Flow Medical,” said Daniel T. Lemaitre, Direct Flow Medical President and Chief Executive Officer. “She will provide superb strategic guidance and has a proven track record in clinical trial execution, which will benefit our U.S. pivotal trial and European registry efforts in progress. She also fosters great industry relationships and can build and motivate teams, which will add tremendous value for us with important stakeholders, both internally and externally.”
About Direct Flow Medical, Inc.
Founded in 2004, Direct Flow Medical, Inc. is a privately-held structural heart company. The Direct Flow Medical Transcatheter Aortic Valve System is commercially available in Europe and is being studied in a pivotal trial in the U.S. The Company is headquartered in Santa Rosa, California, with technology and manufacturing facilities in Lake Forest, California. Direct Flow Medical investors include EDF Ventures, New Leaf Venture Partners, Spray Venture Partners, Foundation Medical Partners, SV Life Sciences, VantagePoint Venture Partners, ePlanet Venture Partners and strategic corporate investors. For further information, please visit the Web site at http://www.directflowmedical.com.
The Direct Flow Medical Transcatheter Aortic Valve System has not been approved for sale in the USA, Canada or Japan.
Direct Flow Medical and the Direct Flow logo are trademarks of Direct Flow Medical, Inc.