" class="no-js "lang="en-US"> MCRA helps TriReme Medical with cardiovascular Balloon Catheter
Monday, February 26, 2024

MCRA Assists TriReme Medical with Obtaining FDA Premarket Approval of Cardiovascular Balloon Catheter

MCRA, a leading medical device-focused regulatory advisory firm and clinical research organization (CRO) integrating US 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 US Food and Drug Administration (FDA) to approve the Chocolate Touch® drug-coated balloon (DCB) percutaneous transluminal angioplasty catheter. This innovative paclitaxel-coated PTA balloon catheter, developed by TriReme Medical, LLC, treats patients with peripheral arterial disease (PAD) of the superficial femoral and popliteal arteries.

MCRA’s expert regulatory affairs and quality assurance teams worked closely with TriReme Medical to achieve this significant milestone. Led by MCRA’s Vice President and Head of Cardiovascular Regulatory Affairs and former FDA Branch Chief of Interventional Cardiology Devices, Michael John, MCRA’s Senior Director of Regulatory Affairs, former Assistant Director of External Rhythm and Rate Devices and Lead Reviewer of Interventional Cardiology Devices Nikki Batista, and MCRA’s Senior Director of Quality Assurance Dan Goldstein, the MCRA team collaborated with TriReme on all aspects of the scientific, regulatory, and manufacturing components of the PMA to assist TriReme Medical in achieving PMA approval for the Chocolate Touch Drug-Coated Balloon.

Michael John, MCRA’s Vice President and Head of Cardiovascular Regulatory Affairs, stated, “Approval of the Chocolate Touch marks a new standard for DCB performance, and we are honored to have played a role in this important PMA approval for TriReme Medical.”

Glenn Stiegman, Senior Vice President of Clinical and Regulatory Affairs at MCRA, said, “MCRA set out in 2019 to build the industry leading cardiovascular medical device consulting firm. Today, this is evidenced by the successful outcome the MCRA team has helped TriReme Medical achieve. We thank TriReme Medical for allowing us to be involved in this important PMA approval to help improve cardiovascular health for patients suffering with peripheral artery disease in the United States.”

Shiva Ardakani, SR. VP of RA/QA & Compliance at TriReme Medical, LLC said, “The Chocolate Touch is a novel platform to treat PAD while minimizing the need for stents and represents a significant advancement in the therapeutic options for patients suffering with PAD. We are pleased to have partnered with such a skilled regulatory and quality consulting firm to bring this innovative cardiovascular product to patients in need.”

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