2023年2月13日

分享這篇文章分享這篇文章提供的新聞華盛頓2月13日2023 / MCRA從LLC領先的醫療設備集中管理谘詢公司和臨床研究機構(CRO)整合美國和國際監管事務,臨床試驗操作,還款和市場準入,醫療合規、網絡安全、質量保證,和日本銷售物流(DMAH)高興地宣布其作用成功上市前的批準(PMA)應用程序決定由美國食品和藥物管理局(FDA)批準巧克力觸摸®藥物塗層球囊(DCB)經皮導管腔間血管成形術。這種創新的紫杉醇塗層PTA氣球導管,由戰船醫療、LLC對待患者外周動脈疾病(PAD)的表麵股膕動脈。MCRA監管事務的專家和質量保證團隊與戰船醫學密切合作,實現這一重要的裏程碑。MCRA為首的副總裁和心血管監管事務和前FDA分支介入性心髒病學主任設備,邁克爾•約翰MCRA監管事務的高級主任,前副主任外部節奏和速度設備介入心髒病學的主要評論家設備尼基巴蒂斯塔,MCRA的高級主管丹•戈爾茨坦質量保證MCRA團隊合作與戰船在科學的各個方麵,監管和生產組件的PMA協助戰船醫療實現PMA批準藥物塗層球囊巧克力聯係。MCRA邁克爾•約翰的副總裁和心血管監管事務負責人表示“批準DCB巧克力觸摸標誌著一個新標準的性能,我們榮幸扮演了一個角色在這個重要PMA戰船醫療批準。”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." 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. www.mcra.com 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. www.vbllc.com 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. www.qtvascular.com/us/ For more information, please contact: Alyssa Howard, Vice President, Business Development SOURCE MCRA, LLC