Washington, D.C., USA, 17 November 2024 - Shanghai MicroPort® Medical (Group) Co., Ltd. (Shanghai MicroPort®), a subsidiary of MicroPort Scientific Corporation (00853.HK), showcased its comprehensive cardiovascular intervention solutions and presented the latest clinical research data to approximately 10,400 experts and physicians worldwide at the 36th Transcatheter Cardiovascular Therapeutics Conference (TCT 2024) in Washington, D.C..
During the conference, MicroPort® announced the one-year clinical results of the TARGET-IV NA study and the results of the TARGET DAPT study for its Firehawk® Coronary Rapamycin Target Eluting Stent System (Firehawk®).
The TARGET-IV NA study is a prospective, multicenter, single-blind, randomized non-inferiority trial designed to compare the clinical outcomes of Firehawk® with second-generation drug-eluting stents (DES) for the treatment of ischemic heart disease. The data demonstrated that all primary endpoints were met, confirming Firehawk®’s safety and efficacy as non-inferior to other FDA-approved stents, despite containing only one-third of the drug dose. The primary endpoint results showed that the 12-month target lesion failure (TLF) rate was 3.4% for the Firehawk® group versus 3.3% for the second-generation DES group, meeting non-inferiority standards (P<0.0001). The ischemia-driven TLR rates were 0.9% and 1.4%, respectively, aligning with the European TARGET AC study outcomes. Both 13-month coronary angiography and optical coherence tomography (OCT) analyses further confirmed the stent's safety and efficacy.
The TARGET DAPT study is a prospective, multicenter, non-inferiority randomized controlled trial that assesses the safety of reducing dual antiplatelet therapy (DAPT) to 3 months following successful Firehawk® implantation in real-world patients. The 18-month follow-up data showed no significant differences in primary endpoint events between the 3-month DAPT group (10.14%) and the 12-month DAPT group (10.90%; P =0.0003). Among high-bleeding-risk patients, the 3-month DAPT group experienced a marked reduction in bleeding events, further demonstrating the safety and effectiveness of Firehawk® under a shortened DAPT regimen. With OCT imaging from the TARGET AC study showing 99.9% endothelial coverage within 3 months, the results provide robust evidence for Firehawk®’s suitability in short-term DAPT strategies.
MicroPort® also introduced its latest-generation bioresorbable scaffolds (BRS), Firesorb®, marking its international debut. Firesorb® utilizes a unique combination of single-sided drug coating and targeted release technology, designed to mitigate the effects of full coating on delayed endothelial healing. Its scaffold’s material and structural optimizations balance support strength and mass while reducing inflammation through its controlled degradation process. Firesorb® achieved an exceptionally low thrombosis rate of 0.32% across all patients in the FUTURE-I, II, and III studies, with no thrombosis event reported in the four-year randomized controlled trial (RCT). This outstanding result underscore Firesorb®’s potential advantages in the bioresorbable scaffold field and received widespread recognition and praise from attending experts.
Additionally, MicroPort® showcased other cardiovascular solutions, including the Firehawk Liberty™ Coronary Rapamycin Target Eluting Stent System, and Firefighter™ and Firefighter™ NC PTCA Balloon Dilatation Catheters. The Firefighter™ NC PRO, recently approved by the FDA, made its North American debut, drawing significant attention for its exceptional performance. MicroPort® anticipates accelerated clinical adoption of Firefighter™ NC PRO in North America, offering high-quality treatment options for physicians and patients.
During the 2024 TCT conference, MicroPort® engaged in in-depth discussions with clinical experts about the ongoing progress of Firehawk® clinical studies and exchanged ideas about future product pipeline planning. The company also sought cross-disciplinary collaboration with external partners to explore potential partnerships. This participation highlighted MicroPort®’s capabilities in medical technology innovation and product development, laying the foundation for comprehensive solutions in cardiovascular intervention, robotics, structural heart disease treatment, and neurointervention.
Looking ahead, MicroPort® is committed to advancing its global strategic layout to meet evolving healthcare needs and drive technological innovation across various fields.
About MicroPort®
Founded in 1998 on the belief that every person has the right to high quality medical treatments, MicroPort® (MicroPort Scientific Corporation; HKEX: 00853) is a global medical devices company. MicroPort® provides solutions across twelve therapeutic areas, including cardiovascular, orthopedics, cardiac rhythm management, electrophysiology, endovascular, neurovascular and surgical robotics among others. For over 26 years, MicroPort® has been breaking barriers and accelerating access to life-changing solutions so that patients everywhere can continue living better and longer lives. With therapeutic solutions that are available in more than 100 countries and over 20,000 hospitals around the world, today, every 5 seconds a patient around the world benefits from a MicroPort® life-changing solution.
More information is available at www.microport.com