Transcatheter heart valve innovator, Direct Flow Medical®, Inc., has appointed a new Vice President, Regulatory and Clinical Affairs in the form of Mary Edwards.
Direct Flow Medical, Inc. is no stranger to our news site as we’ve followed the progress of its novel Transcatheter Aortic Valve System, which is now commercially available in Europe and is being studied in the pivotal SALUS trial in the U.S., a study that will now fall under the remit of new incumbent VP, Ms. Edwards. She will oversee all global clinical and regulatory efforts, including administration of the aforementioned pivotal trial, 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.”
Source: Direct Flow Medical, Inc.