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    Home > Medical News > Medical World News > "Heart Valve Circuit" is surging: domestic giants "Three Kingdoms"

    "Heart Valve Circuit" is surging: domestic giants "Three Kingdoms"

    • Last Update: 2021-07-14
    • Source: Internet
    • Author: User
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    On March 22, Qiming Medical announced that its core product, VenusP-Valve, a transcatheter prosthetic pulmonary valve system, has obtained a special use license from the British Medicines Agency (MHRA) and can be used in designated medical institutions
    .
    This special license means that VenusP-Valve can enter the UK market in advance without obtaining CE certification
    .
    After the national acquisition of coronary stents, heart valves, as an innovative product in the field of cardiovascular intervention, are in a relatively high-growth stage and have received wide attention from the market and capital
    .
    In addition to Qiming Medical, there are currently no less than 10 domestic companies that have deployed TAVR tracks
    .
    Domestically-produced companies have followed suit, and a large wave of waves are rushing to enter the market to grab the cake.
    From the time of market launch, more products will enter the market in the next three to five years
    .
    The prelude to the race track market has begun .

    For business on the apex, try to see who has deployed
    Heart valve disease is a structural heart disease that can be treated by surgery
    .
    So far, the surgical procedures for heart valve diseases are divided into: traditional open thoracic surgery (SAVR), minimally invasive valve surgery, and transcatheter valve therapy (TVT)
    .
    Among them, four treatment methods using TVT technology are called: transcatheter aortic valve replacement (TAVR), transcatheter pulmonary valve replacement (TPVR), transcatheter mitral valve replacement (TMVR), transcatheter tricuspid Valve replacement (TTVR)
    .
    Currently TAVR is heart valve field competition of the main battlefield, the international market has Edwards Life Sciences, Medtronic, Boston Scientific three medical device companies account for more than 90% of the TAVR market, basically formed the "troika" pull market structure development of the industry
    .
    The domestic market presents a pattern of 3 domestic products (Qiming Medical, Jiecheng Medical, and MicroPort) + 1 import (Edward)
    .
    At present, a total of five domestic products have been approved for listing, namely Edward Life Sciences' SAPIEN 3, Qiming Medical's VenusA-valve and its second-generation product VenusA-Plus, Suzhou Jiecheng's J-Valve and Wicresoft's VitaFlow
    .

      Edward's Sapien 3
    imported product from Edward Life Sciences, Edward's Sapien 3 is China's first imported TAVR product
    .
    Compared with the previous generation valve, SAPIEN 3 has a higher height and a better positioning of the doctor.
    The skirt is attached to the periphery, which greatly reduces paravalvular leakage
    .
    Compared with other self-expanding valves, SAPIEN 3 is shorter.
    Its biggest advantage is when applied to low-risk patients, it can provide a good entrance for subsequent coronary interventions
    .
    At the same time, the size of the valve annulus can be controlled by the balloon.
    The delivery system is adjustable and has its advantages when passing through the twisted aortic valve, which greatly reduces the mortality rate during the perioperative period
    .

      Qiming Medical’s Venus
    Qiming Medical is the first company in China to conduct clinical trials of valves .
    VenusP-Valve has been in clinical use for 8 years since 2013, and 55 cases have been enrolled in clinical trials in China
    .
    The function of the VenusP-Valve valve is well maintained, showing good safety, effectiveness and operability
    .
    The important feature of Qiming Medical's second-generation products is that they are recyclable, and recyclable products are more conducive to beginners
    .
    In addition, it can make the implantation more accurate, reduce the use rate of pacemakers and the assistance of surgical operations, and bring better prognosis
    .

      J-Valve J-Valve
    J-Valve is China’s first original interventional heart valve with international intellectual property protection
    .
    The J-Valve heart valve can completely rely on the positioning system, such as the system itself, to accurately locate the implant site and firmly fix the valve
    .
    There is no need to open the chest, no extracorporeal blood circulation, and the heart keeps beating during the operation, which is of great significance to the treatment of elderly patients
    .
    The operation is simple, and the valve implantation during the operation only takes about 5 minutes on average, which reduces the risk of the operation, improves the safety, and is easy for the doctor to operate
    .

      Minimally invasive heart through the VitaFlow
    invasive delivery system through the heart of the electric VitaFlow handle can be more accurately at the time of release, for doctors motorized handle operation easier
    .
    The mixed density grid nickel-titanium stent used enables the valve to effectively propagate the calcified leaflets, and has excellent coaxial and positioning performance during the release process
    .
    In addition, VitaFlow has also developed a double-layer skirt design to achieve a lower all-cause mortality and postoperative complications
    .
    Compared with other TAVR products that have been commercialized in China and around the world, VitaFlow has achieved best-in-class clinical trial results, reflected in all-cause mortality and postoperative complications (including moderate/severe paravalvular leakage, severe stroke) Incidence rate and other indicators
    .
    And the price is more than 30% cheaper than the existing products on the domestic market, which has a higher cost performance
    .
    From a technical point of view, these products currently on the market have large differences, which are mainly reflected in data such as valve raw materials, intervention methods, and expansion methods
    .
    Valve raw materials: Qiming Medical and Medtronic products use porcine pericardium, Jiecheng Medical uses porcine aortic valve, and MicroPort, Peijia Medical and Edward use bovine pericardium; Intervention method: Jiecheng Medical uses transapical method, others All products use transfemoral artery intervention, while Edward includes transfemoral artery and transapical
    .
    At present, the mainstream intervention route is via the femoral artery, which is the minimally traumatic intervention route
    .
    For patients whose blood vessels are too thin or vascular disease cannot be treated peripherally, the treatment can be done through the apex or through the aorta
    .
    Research points out that the survival rate data after transfemoral artery surgery is better than transapical; Expansion method: Domestic products all use self-expansion technology.
    Currently, Medtronic, which is temporarily entering the Chinese market, also uses self-expansion technology, while Edward uses balloon-assisted expansion surgery
    .
    The operation methods of the two are different.
    From a technical point of view, the positioning accuracy of balloon-assisted expansion may be higher
    .
    And comparative studies have found that patients implanted with self-expanding valves have a higher risk of paravalvular leakage, as well as higher perioperative and 2-year mortality
    .
    The minimum size of the delivery system: domestic products are between 16-18F, and the minimum size of Edward and Medtronic can reach 14F, which can make their products have a certain advantage in patients with thinner blood vessels
    .
    From the comparison of clinical data, the currently marketed product, MicroPort Heart Pass, has excellent safety data.
    Qiming Medical is the only domestic product with long-term clinical safety data
    .
    On the whole, Sapien 3 of Edward Life Sciences is not currently competitive in China.
    The 1-year mortality rate is relatively high.
    It may be that the imported products do not conform to the human body structure of the Chinese
    .
    In addition, it is not the dominant party in terms of price and time
    .
    However, Jiecheng Medical's business has been in crisis and litigated
    .
    Therefore, the two major competitors in the domestic TAVR field are MicroPort Xintong and Qiming Medical
    .
    Whether it is in terms of technological maturity, market cultivation, and doctors' education and learning, Qiming Medical is the absolute leader in the current TAVR market in China
    .
    However, as a latecomer, MicroPort Xintong VitaFlow has the fastest market growth
    .
    Compared with other products that have been commercialized in China, it has achieved better clinical trial results, stronger technology and lower prices, and has shown the potential to subvert Qiming's leading position in medical care
    .

     After the waves rush to enter the market, the competition in the TAVR field intensifies
    In addition to Qiming Medical, Jiecheng Medical, Minimally Invasive Cardiovascular and Edwards, latecomers such as Peijia Medical, Lepu Medical, and Bairen Medical have accelerated their deployment in the TAVR field
    .
    Judging from the expected time to market, more new products will be launched in the next three to five years, and the competition in the TAVR field will further intensify
    .

      Peijia Medical
    ’s TaurusOne holds eight related patents, which are mainly designed to treat aortic valve diseases using a transcatheter method
    .
    The surgical path of this product is similar to Qiming Medical's VenusA-Valve and Minimally Invasive Medical's VitaFlow.
    Both enter through the femoral artery path, with small surgical wounds, high safety, and good market acceptance
    .
    It is currently in confirmatory clinical trials and is expected to be approved by the National Regulatory Authority and listed in the first or second quarter of 2021
    .


    Lepu   Medical is the first company in China to study TAVR.
    Recently, Lepu Medical’s "evaluation of the safety and effectiveness of the transcatheter implantable aortic valve system in the treatment of symptomatic, calcified, and severe aortic stenosis" is prospective.
    , Multi-center, single-group target value research clinical trials" successfully passed the registration of the Ministry of Science and Technology Human Genetic Resources International Cooperative Clinical Trials, and officially entered the NMPA registered clinical research
    .

      Bai Ren Medical
    Bai Ren Medical surgical valve is the first field cultivators, recently, in the heart of the field of valves, Bai Ren medical intervention ball valve type expansion debut, completed the world's first aortic, mitral, tricuspid joint "flap "Medium flap" surgery
    .
    This interventional valve system is an interventional bovine pericardial valve system, which is composed of a valve, a delivery system, a pressure holder, a puncture sheath and other components.
    It can be used for the first interventional treatment of the aortic valve and the damage of the previous artificial biological valve at each valve position.
    Re-interventional therapy, and future interventional therapy for various valvular diseases
    .
    It is still in the clinical trial stage and will be registered as soon as the end of 2023
    .

      Jinshi Sheng matter
    as early surgical valve manufacturer, Jinshi Sheng matter has a profound accumulation of technology, research and development of the third generation of its intervention aortic valve Pro>
    .
    The field of heart valves is one of the fastest-growing tracks in the field of innovative medical devices in the future.
    Under the background of encouraging the "domestic substitution" of medical devices, imported brands have limited short-term impact on the domestic market
    .
    At present, Qiming Medical, Jiecheng Medical and Minimally Invasive Medical are relatively leading in R&D and listing progress
    .
    As more and more companies enter, in the TAVR market competition, it is worth looking forward to whether the first mover will continue to maintain the first mover advantage or the latecomer will take the lead
    .
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