Ex-Medtronic Reg Exec Joins Direct Flow
This article was originally published in Clinica
Transcatehter aortic valve replacement technology company Direct Flow Medical, Inc., has appointed Mary Edwards as Vice President, Regulatory and Clinical Affairs. Edwards has over 30 years’ regulatory and clinical affairs experience, and has overseen several US premarket approvals and product clearances for medtech heavyweights such as Medtronic, CR Bard and W.L. Gore & Associates. At Direct Flow, she will be responsible for all the Santa Rosa, California company’s global clinical and regulatory efforts, including administration of the US SALUS pivotal trial of Direct Flow’s TAVR system, as well as the DISCOVER post-market European study.