Shanghai, China, 25 January 2022 - Recently, the TARGET PREMIER project, a pre-market clinical study of the next-generation rapamycin target eluting coronary stent, initiated by Shanghai MicroPort Medical (Group) Ltd. (MicroPort®), has enrolled its first patient. The patient was recruited by the trial’s lead investigator, Prof. Zhixiong Zhong of Meizhou People’s Hospital in China.
TARGET PREMIER is a prospective, multicenter, single-arm clinical trial designed to evaluate the safety and efficacy of the rapamycin target eluting stent system for the treatment of primary coronary artery stenosis lesions. The study is expected to enroll 200 subjects with primary coronary stenosis, with the primary endpoint of late in-stent lumen loss at 9 months after baseline surgery. The trial’s secondary endpoints include target lesion failure, incidence of target lesions, target vessel revascularization and in-stent thrombosis at 5 years post-procedure.
Firehawk® stent is the world's first drug-eluting stent system developed by MicroPort® with a proprietary technology for loading drugs in the non-vascular luminal surface of the stent beam and providing precise targeted drug release. The rapamycin target eluting stent used in this clinical trial is the third generation of the Firehawk® product family. The third generation optimizes the design and size of the stent platform, but maintains the advantages of the previous two generations, including low drug loading and polymer content.. Additionally, it further reduces the thickness of the stent beam, and is as safe as metal stents and as effective as drug stents. These features help to further shorten endothelialization time and reduce the incidence of in-stent thrombosis and myocardial infarction.
“MicroPort® Firehawk® stent has shown good results in clinical use. The trial stent in the TARGET PREMIER study also uses the same technology of drug delivery in the tiny grooves on the non-luminal surface of the stent beam to achieve targeted release, with optimized stent structure,” noted Prof. Zhixiong Zhong. “We are confident that the clinical study will be successfully completed. As the project leader, our research team is committed to completing the study with high efficiency and quality to provide new options for cardiovascular physicians in the process of coronary intervention."
According to Mr. Ming Zheng, Senior Vice President of Clinical Medicine at MicroPort®, since the launch of the first-generation product in 2014, Firehawk® stents have become globally leading solutions for their representation of the new standard of the next-generation cardiac stents. Maintaining a high level of investment in research and development and clinical trials, MicroPort® keeps conducting large-scale clinical studies for coronary stents around the world to enrich its cardiovascular interventional product line and bring benefits to more patients with coronary heart disease.
About Shanghai MicroPort Medical (Group) Co., Ltd.
Shanghai MicroPort Medical (Group) Co., Ltd. is a subsidiary of MicroPort Scientific Corporation (stock code: 00853.HK). As a leader in high-end innovative medical solutions, MicroPort® places emphasis on the human dimension while integrating the pursuit of perfection and innovation into the corporate DNA. In the future, MicroPort® will continue to pursue an innovative, people-centered culture to provide patients and physicians with higher-quality, innovative high-end medical devices and integrated solutions.