TMCnet News

MCRA Assists TriReme Medical with Obtaining FDA Premarket Approval of Cardiovascular Balloon Catheter
[February 13, 2023]

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

WASHINGTON, Feb. 13, 2023 /PRNewswire/ -- MCRA, LLC, 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 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 allwing 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."

About MCRA, LLC: MCRA is the leading privately held independent medical device, diagnostics and biologics Clinical Research Organization (CRO) and advisory firm. MCRA delivers to its client's industry experience, integrating its six business value creators: regulatory, clinical research, reimbursement, healthcare compliance, quality assurance, and distribution logistics to provide a dynamic, market-leading effort from innovation conception to commercialization. MCRA's integrated application of these key value-creating initiatives provides unparalleled value for its clients. MCRA has offices in Washington, DC, Hartford, CT, New York, NY, and Tokyo, Japan and serves nearly 1,000 clients globally. Its core focus areas of therapeutic experience include orthopedics, spine, biologics, cardiovascular, diagnostic imaging, wound care, artificial intelligence, dental, anesthesia, general surgery, digital health, neurology, robotics, oncology, general and plastic surgery, urology, and in vitro diagnostic (IVD) devices and medical device cybersecurity.

About Viscogliosi Brothers, LLC: Viscogliosi Brothers, LLC (VB), founded MCRA in 2004. VB is headquartered in New York City and specialized in funding venture capital, private equity, and merchant banking activities for the neuromusculoskeletal industry. VB is dedicated to financing healthcare innovation. 

About TriReme Medical LLC: TriReme Medical, LLC, a subsidiary of QT Vascular, is a US medical device company based in Pleasanton, California. Founded in 2005, it is dedicated to developing, manufacturing and distributing advanced therapeutic solutions for the treatment of complex vascular disease. Addressing specific unmet clinical needs, TriReme is working with leading engineers and global thought leaders to offer physicians new and differentiated devices to improve outcomes in complex peripheral and coronary interventions.

For more information, please contact:
Alyssa Howard, Vice President, Business Development
Phone: 215.870.3952 | Email: [email protected]

Cision View original content to download multimedia:


[ Back To's Homepage ]