Shanghai, China, 28 November 2022 – MicroPort Scientific Corporation (MicroPort®), a global leading medical device company, announced today that the last patient enrollment for the TARGET IV-NA clinical trial has been completed at the Quebec Heart Lung Institute, Quebec, Canada.
The TARGET IV-NA trial is a 1,720-patient clinical study across 66 clinical sites in the U.S., Europe and Canada designed to assess the safety and effectiveness of the Firehawk™ Target Eluting Stent system (Firehawk™) compared against currently approved second generation drug eluting stents (DES). The clinical data for this study will support the U.S. Food and Drug Administration (FDA) and Canada regulatory approvals of Firehawk™ for the treatment of atherosclerotic coronary lesions.
“The Firehawk™ stent is a thin-strut DES with the lowest drug and bioabsorbable polymer load of all DES on the market. Firehawk™ is also one of the most conformable and deliverable drug-eluting stent platforms," commented the chairman of the study, Martin B. Leon, MD, Professor of Medicine at New York-Presbyterian/Columbia University Medical Center, New York, US, "I am excited about the potential impact of Firehawk™ on patient care, as it was designed for fast healing and should reduce the risk of late adverse events and the need for prolonged dual antiplatelet therapy, which may be associated with a higher risk of bleeding and increased cost."
“The Firehawk™ stents performed very well,” said Dr. Olivier Bertrand from Quebec Heart-Lung Institute, Quebec, Canada, whose center has contributed substantially in TARGET IV-NA with highest patient enrollment. “We are looking to closely follow-up their entire cohort of patients, with repeat OCT imaging at 12 months in some of them to provide detailed and complete analysis of stent performance.”
The TARGET IV-NA clinical trial builds upon the TARGET series studies. The Firehawk™ stent has been extensively studied in China and Europe in 2,084 patients through a comprehensive clinical program called TARGET, which includes TARGET First-in-Man (TARGET FIM), TARGET I RCT, TARGET I Long, TARGET II and TARGET AC studies. MicroPort® received China Food and Drug Administration (CFDA) approval for Firehawk™ in January 2014 and CE Mark approval in January 2015. Since receiving approval in China and Europe, Firehawk™ stent is now available in over 60 countries and regions.
MicroPort Scientific Corporation (the "Group" or “MicroPort”, stock code: 00853.HK) is a leading medical device company with business focusing on innovating, manufacturing, and marketing high-quality and high-end medical devices globally. With a diverse portfolio of products now being used at an average rate of one for every 6 seconds in thousands of major hospitals around the world, the Group maintains world-wide operations in a broad range of business segments including Cardiovascular, Orthopedic, Electrophysiological, Endovascular, Neurovascular, Surgical, Diabetes Care and Endocrinal Management, and others. MicroPort is dedicated to becoming a patient oriented global enterprise improve and reshape patient lives through application of innovative science and technology.
For more information, please refer to: www.microport.com.