Shanghai, China, 17 February 2024 - MicroPort® RotaPace, an associated company of MicroPort® Coronary, has officially received market approval in China for the TomaHawk® Integrated Coronary Intravascular Lithotripsy System (TomaHawk®). The system includes a disposable coronary intravascular lithotripsy (IVL) balloon catheter and treatment device, offering a new solution for the treatment of complex coronary artery disease.
Severe coronary artery calcification significantly challenges both surgical success and patient prognosis in coronary interventions. Addressing the clinical challenges of treating moderate to severe calcification lesions, MicroPort® RotaPace has developed the TomaHawk® Integrated Coronary Intravascular Lithotripsy System based on the innovative intravascular lithotripsy (IVL) technology. The system is designed to reduce operational complexity, minimize complications risks, enhance the safety of the procedure, and simplify the operation for clinicians, ultimately reducing the learning curve. It also promotes the clinical application of pre-treatment for moderate to severe calcification lesions, benefiting more patients.
TomaHawk® applies the principles of traditional lithotripsy to balloon angioplasty, using high-energy shockwaves to fracture calcified plaques within arterial walls. This pre-treatment enhances vascular compliance, facilitates smoother device delivery, and ensures optimal stent expansion and apposition for improved clinical outcomes.
TomaHawk® introduces the world’s first real-time balloon pressure monitoring function, which prevents pulse release in the event of balloon rupture or insufficient inflation, ensuring safe and effective energy transmission. The exclusive patented “TomaHawk Electrode” emitter design delivers shockwave effects equivalent to 50atm, while maintaining an ultra-low outer diameter of only 0.031 inches, enabling seamless navigation through complex lesions. Additionally, the balloon features a three-layer composite material that optimizes flexibility and trackability, ensuring safe expansion even in heavily calcified vessels. To meet diverse clinical needs, TomaHawk® is available in 18 different specifications, making it the most versatile shockwave catheters on the market.
The market launch of TomaHawk® expands treatment options for coronary calcification pre-treatment. Along with the MicroPort® Coronary Scoring Balloon and Rotational Atherectomy System, it offers a comprehensive solution for high-resistance coronary lesions, providing interventional cardiologists with advanced tools to tackle challenging cases. Moving forward, MicroPort® Coronary will continue to develop innovative and accessible solutions to improve patients outcomes and support healthcare professionals around the world.
About MicroPort® RotaPace
Founded in 2020, MicroPort® RotaPace (Shanghai MicroPort RotaPace MedTech Co., Ltd.), an associated company of MicroPort® Coronary (Shanghai MicroPort Medical (Group) Co., Ltd.), is an innovative high-end medical device company focusing on the R&D, manufacturing, and commercialization of panvascular access interventional devices. MicroPort® RotaPace pioneers new advancements in cardiovascular interventional active medical devices, prioritizing innovations for complex PCI surgeries and post-PCI recovery, further expanding its interventional cardiovascular treatment portfolio.