Shanghai, China (February 19 2021) - MicroPort Scientific Corporation (“MicroPort”) (HKSE: 0853), a leading global medical device company, announced today that the first patient has been enrolled in the TARGET IV NA, the clinical trial designed to assess the safety and effectiveness of the Firehawk Target Eluting Stentsystem in support U.S. Food and Drug Administration (FDA), Canada and Japanese regulatory approvals for the treatment of atherosclerotic coronary lesions. The TARGET IV NA clinical program is anticipated to enroll approximately 1,616 patients at up to 100 sites in the United States, Canada, Europe, and Japan. The Firehawk stent uses a proprietary design whereby tiny recessed grooves have been etched on the outer surface (abluminal side) of the stent struts that allow for controlled release of sirolimus drug, such that 90% of the drug is released by 90 days and the polymer degrades within 6 to 9 months. The first patient was enrolled by Dr. Jayendrakumar Shantilal Patel at Clearwater Cardiovascular Consultants in Clearwater, Florida.
“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," said the chairman of the study Martin B. Leon, MD is Professor of Medicine at NewYork-Presbyterian/Columbia University Medical Center, "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 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 CFDA approval for Firehawk in January 2014 and CE Mark approval in January 2015. Since receiving approval in each respective country, Firehawk stent has been sale over 40 countries in the world.
"The launch of the TARGET IV NA clinical trial is a tremendous milestone for MicroPort," said Dr. Ming Zheng, the First president of Clinical Science and Medical affairs at MicroPort. “We look forward to continuing to expand on the body of medical evidence that is already available to support the use of Firehawk to increase the advanced treatment options available to physicians and patients in the US, Canada and Japan." Patients enrolled in the TARGET IV NA trial will be followed for five years. The Firehawk stent system is an investigational device and is not available for sale in the United States, Canada and Japan.
MicroPort Scientific Corporation (the "Group") 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.