Sherpa-Backed Huihe Medical Receives NMPA Approval for C-Wave® Coronary Intravascular Lithotripsy Catheter
H&H Healthcare
R&D and Producer of Interventional Medical Devices for Heart Disease
Shanghai HuiHe Healthcare Technology Co., Ltd.HealthcareTechnology Co., Ltd.Co., Ltd. (hereinafter referred to as“HuiHeHealthcare”) The coronary artery intravascular shock wave treatment system independently developed has officially received approval from the National Medical Products Administration (NMPA) Approved for Marketing！
This is a product withIndependent Intellectual Property Rights, adopting a uniqueS-shaped spiral electrodeThe designed shock wave catheter has the advantages of more balanced energy and more stable discharge.
HuiHe Healthcare C-Wave®Becoming the first to simultaneously haveCoronary and PeripheralChinese Brand of Shock Wave Catheters.
Coronary Artery "Calcium" Dilemma
Vascular calcification has always been the most challenging problem for coronary physicians in clinical practice. Traditional cutting balloons, scoring balloons, and rotational atherectomy techniques all provide effective tools for cardiologists to achieve lumen gain. However, when facing intimal calcification, eccentric calcification, or circumferential calcification, the latest...IVLTechnology has become an effective and safe solution.
IVL is a combination of hydraulic lithotripsy and endovascular dilation technologies, innovatively utilizing shockwave energy to activate microbubbles at high voltage, creating high-energy impedance on the calcified surface. This effectively cracks stubborn plaques without damaging the intima or causing dissection and rupture.
HuiHe Healthcare has made improvements on the basis of the already listed IVL, retaining the inherent characteristics of IVL: activating the electrohydraulic effect with shockwave energy to crack calcification down to the middle membrane layer, thereby obtaining the lumen; it has further iterated by focusing on balanced angular discharge in the short-axis plane and continuous discharge in the long-axis plane, introducing a device with...C-Wave with Independent Intellectual Property Rights®Coronary Shockwave Catheter (China Medical Device Registration No. 20243010990)。
According to public information, Shockwave®IVL Technology Used in Coronary Arteries for the First Time: Its Catheter Employs Circular Electrode Distribution, Focusing Energy on Both Ends, Achieving Good Results in Coronary Artery Calcified Lesions.
C-Wave®Considering the severity of calcified sections and the continuity along the vessels in Chinese patients,Invented the S-shaped spiral electrode distribution, arranging six electrodes continuously along the long axis in an "S" shape, which has a stronger opening ability for continuous calcification, nodular calcification, and eccentric calcification lesions.
HuiHe Healthcare's C-Wave®Globally, In ChinaApplied54 itemsPatent，36 items have been authorized, of which 25 are invention patents.。
C-Wave®As the world's first shock wave catheter equipped with an S-shaped spiral electrode arrangement, the coronary artery catheter features two sets of electrodes for clockwise and counterclockwise rotation, with both electrodes firing simultaneously. Each firing effectively activates 4 discharge points, generating 4 shock waves. Each catheter can be fired 80 times, delivering up to 320 shock wave discharge points in total.
With the gradual popularization of shock wave technology, the field of coronary artery calcium treatment is expected to usher in the era of shock waves. C-Wave®The registration clinical study of coronary arteries enrolled 183 patients across 10 hospitals. The success rate of surgeries and the incidence of adverse cardiovascular events were satisfactory, reaching the same level as international peer clinical trials such as CADIII.
At the same time, in order to meet the clinical needs of patients in China, C-Wave®The coronary shockwave catheter is available in specifications with 0.25mm increments, and its catheter (balloon) comes in seven sizes ranging from 2.5mm to 4.00mm.
C-Wave®The shock wave generator (main unit) is equipped with a 7-inch large display, which can show information such as catheter model, activation status, and number of activations, meeting clinical visualization needs.
C-Wave®Developed and manufactured by the ZhongHui team of HuiHe Healthcare. With its strong independent research and development capabilities, HuiHe Healthcare has obtained certifications for world-first products in the fields of structural heart disease, coronary vascular intervention, peripheral vascular intervention, oncology vascular intervention, and intelligent intervention, entering commercialization and filling multiple market gaps in China and even globally.
K-Clip®Transcatheter Tricuspid Annuloplasty System, Vispearl®Visible drug-loaded embolic microspheres, S-wanTM dual-control bend catheter sheaths, and more. Multiple products have successfully entered developed countries such as North America and the European Union.
HuiHe Healthcare has more than 120 R&D personnel, an 8,000-square-meter R&D and production site, and owns over 230 patents in total, including 170 invention patents and more than 10 PCT patents. HuiHe Healthcare has deep expertise in the fields of high-precision metal processing, fluid dynamics simulation, and polymer material molding, and is committed to working with industry experts to advance the implementation of the "Healthy China 2030" plan, becoming a "new quality productive force"!
Welcome partners from all channels to contact HuiHe Healthcare:
If you have any questions, comments, suggestions, or cooperation needs regarding HuiHe Healthcare's products, please contact the company's inquiry email:
question@hh-healthcare.com
About
Sherpa Investment
Sherpa Investment is a fund management company focused on early and growth-stage healthcare investments. WeAdhere to the concept of "investing early, investing in innovation, and investing accurately."Based on the long-term accumulated industry knowledge and advantageous resources,Targeting the unmet rigid clinical needs in the field of major diseases, we build an investment portfolio around tracks such as gene technology and its applications, biopharmaceuticals, device diagnostics, and digital healthcare. We expand along the industry's depth and upstream/downstream sectors to form enterprise synergies, with investment layouts in both China and the United States.
The Sherpa team, with both industrial and investment backgrounds, supports critical decision-making at key stages of enterprise development by actively sharing operational management experience and providing a forward-looking perspective across the entire industry chain, helping companies achieve growth in business performance and corporate value.Ten years of honing a single sword, long-term professional focus, and accumulated learning have built the Sherpa Investment brand and established a comprehensive capability system covering project sourcing, post-investment value-added services, exits, and more.
The medical enterprises invested in and led by Sherpa team members in China and abroad include Innovent Biologics, New Horizon Health, Belief BioMed, Berry Genomics, NanoView Biosciences, Singleron Biotechnologies, NorthX Biologics, WuXi AppTec, WuXi Biologics, Cytek Biosciences, Axonics, Urotronic, Visen Pharmaceuticals, Avida Biomed, Alamar Biosciences, Bota Bio, Vazyme Biotech, OBiO Technology, XinWei Medical, Olive Branch Health, Jianhai Medical, Maccine, and more than a hundred other companies.
Adhering to the values of "investing in health, achieving others and oneself," the Sherpa team is honored to join hands with many outstanding entrepreneurs. Through innovative technologies and products, we contribute to human health, participate in and witness the growth of China's medical industry together, and strive to become the most trusted Sherpa for entrepreneurs scaling the peak of life sciences.
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