MCRA, a leading medical device focused regulatory advisory firm and clinical research organization (CRO) integrating U.S. and International Regulatory Affairs, Clinical Trial Operations, Reimbursement and Market Access, Healthcare Compliance, Cybersecurity, Quality Assurance, and Japan Distribution Logistics (DMAH) is pleased to announce its role in the successful Premarket Approval (PMA) application decision by the U.S. Food and Drug Administration (FDA) to approve the SurVeil drug-coated balloon (DCB) to treat peripheral artery disease (PAD).
The SurVeil drug-coated balloon is a next-generation device that utilizes best-in-class technology in the treatment of peripheral artery disease (PAD), includes a proprietary drug-excipient formulation for a durable balloon coating and is manufactured using an innovative process to improve coating uniformity.
Michael John, MCRA’s Vice President and Head of Cardiovascular Regulatory Affairs, stated, “Working with Surmodics on the SurVeil drug-coated balloon was a great example of expert collaboration between our Regulatory and Biocompatibility teams, which enabled MCRA to both develop the robust technical discussions and then articulate them to FDA in terms of safety, effectiveness and favorable benefit-risk profile. As FDA expectations continue to evolve with advances in scientific understanding, it is imperative that organizations utilize a range of top technical and regulatory experts to keep pace. The Surmodics team understood the importance of this collaboration, and we are honored to have played a part in this important PMA approval.”
Glenn Stiegman, Senior Vice President of Clinical and Regulatory Affairs said, “MCRA’s mission is to provide the full range of services needed for the medical device industry to achieve their goals and improve patient care. We are seeing the marrying of both clinical and preclinical expertise as critical to getting these products across the goal line. Today’s Biocompatibility expectations are extensive, thereby presenting a significant hurdle for many companies and their devices. For Surmodics, we were able to integrate our biocompatibility expertise with our cardiovascular regulatory experience to create a successful outcome. We thank Surmodics for trusting us to help them achieve their goals for the SurVeil drug-coated balloon.”
Gary Maharaj, President and CEO of Surmodics and a member of the SurVeil DCB development team said, “We would like to thank Michael John and MCRA’s team of cardiovascular Regulatory and Biocompatibility experts for their critical contributions along the entire gamut from detailed technical feedback up to and including the strategic guidance on key decisions along the way. This is a rare combination in our experience. Finally, our team enjoyed the spirit of camaraderie and candor in our working relationship with MCRA.”
Source: Company Press Release
