MCRA Collaborates with Surmodics to Secure FDA Pre-Market Approval for Innovative Cardiovascular Drug-Coated Balloon
Tuesday, August 08, 2023
MCRA, a renowned regulatory advisory firm and clinical research organization with a focus on medical devices, has played a significant role in the recent achievement of Pre-Market Approval (PMA) from the U.S. Food and Drug Administration (FDA) for Surmodics' groundbreaking SurVeil™ drug-coated balloon (DCB), designed to address peripheral artery disease (PAD).
The SurVeil™ DCB, an advanced solution for treating PAD, features an exclusive drug-excipient formulation for a durable balloon coating and is manufactured using an innovative process to enhance coating consistency.
The collaboration between MCRA's Regulatory and Biocompatibility teams, demonstrated through the Surmodics project, showcases their ability to facilitate technical discussions and effectively communicate them to the FDA, emphasizing safety, effectiveness, and a favorable benefit-risk profile. In a landscape of evolving FDA expectations driven by scientific progress, tapping into specialized technical and regulatory expertise remains essential for organizations. MCRA remains committed to their mission of providing comprehensive services essential for the medical device sector to achieve their goals and enhance patient care.