Beijing Anzhen Hospital

WUXI, China, March 7, 2024 /PRNewswire/ -- Silk Road Medical (NASDAQ: SILK), a medical device company based in California USA and Genesis MedTech Group have signed an exclusive distribution agreement to introduce the TCAR® core products, ENROUTE® Transcarotid Neuroprotection System and ENROUTE® Transcarotid Stent System, in China. TCAR (Transcarotid Artery Revascularization) is an innovative minimally invasive surgical procedure used to treat carotid artery disease, a condition characterized by the narrowing or blockage of the carotid arteries in the neck. This narrowing or blockage can restrict blood flow to the brain and increase the risk of stroke. Since its establishment in 2019, Genesis MedTech Group has continuously strived to enhance its peripheral interventional portfolio, offering comprehensive solutions to both physicians and patients. Through its commercial team and distribution network, patients in China will now have access to the core TCAR products, the ENROUTE® Neuroprotection System and Stent Delivery System. TCAR has shown to reduce the risk of stroke, death, myocardial infraction (MI), and Cranial Nerve Injury (CNI). It is a less invasive procedure with lower rates of procedural complications and an overall improvement in outcomes, contributing to a positive impact on healthcare. Carotid artery disease often occurs in the middle-aged and elderly population, especially among those with atherosclerosis. The condition is characterized by the buildup of plaque, and over time can cause narrowing or blockage of the carotid arteries, affecting blood supply to the brain and leading to diseases such as ischemic stroke. In recent years, stroke has become the second leading cause of mortality worldwide. In China, it now ranks as the primary cause of death and disability. Each year, over 17 million strokes affect individuals over 40 years old. Notably, around one third of ischemic strokes are caused by carotid artery disease. In the United States, TCAR is rapidly replacing traditional procedures. As of the end of 2023, over 85,000 TCAR procedures have been performed. Before the introduction of TCAR, moderate to severe carotid artery disease was generally treated clinically with two surgical methods: Carotid Endarterectomy (CEA) and Transfemoral Carotid Artery Stenting (TFCAS). However, CEA involves a large incision and carries a higher risk of complications, posing a risk of damage to the cranial nerves of patients. Studies have also shown a higher risk of stroke during TFCAS as compared to TCAR and CEA. Based on clinical studies, TCAR is an advancement in the management of carotid artery disease. Professor Chen Zhong, Chairman, Vascular Surgery Group of Chinese Medical Association, President, Vascular Surgery Physicians Branch of Chinese Medical Doctor Association and Chief Physician, Vascular Surgery at Beijing Anzhen Hospital, commented, "There is considerable evidence showing that TCAR offers advantages for patients with symptomatic carotid artery stenosis or those at anatomical or surgical risk." Silk Road Medical's CEO, Chas McKhann stated, "This agreement represents a promising initial step towards expanding the reach of the TCAR therapy with the offering of our ENROUTE Neuroprotection System and Stent Delivery System to more patients worldwide, including those in China. We are very pleased to have partnered with Genesis MedTech, a respected leader in medtech, who shares our vision for the potential impact of TCAR in preventing strokes." "Enabling TCAR to be made accessible to the patients in China certainly marks another milestone in our efforts to bring innovative treatments to our patients. Together with Silk Road Medical, we remain dedicated to make better healthcare more accessible, improving patient care and outcomes." shared Warren Wang, Genesis MedTech Group's Chairman and CEO. ABOUT GENESIS MEDTECH Genesis MedTech Group is a medical device company headquartered in Singapore. Founded by a group of professionals and entrepreneurs with MedTech experience globally, the company's product portfolio focuses on multi-therapy medical device products for emerging markets with sales and distribution through its established commercial network. Genesis MedTech Group covers the entire industry value chain of research and development, production, quality management, supply chain, marketing, and sales. For more information, visit ABOUT SILK ROAD MEDICAL and TCAR Silk Road Medical, Inc. (NASDAQ: SILK), is a medical device company located in Sunnyvale, California, and Plymouth, Minnesota, that is focused on reducing the risk of stroke and its devastating impact. The company has pioneered a new approach for the treatment of carotid artery disease called TransCarotid Artery Revascularization (TCAR). TCAR is a clinically proven procedure combining surgical principles of neuroprotection with minimally invasive endovascular techniques to treat blockages in the carotid artery at risk of causing a stroke. For more information on how Silk Road Medical is delivering brighter patient outcomes through brighter clinical thinking, visit and connect on Twitter, LinkedIn and Facebook. References SOURCE Genesis MedTech

With the accelerated ageing of the global population and the trend towards paying attention to healthcare, people concern more about health checkup, disease prevention and regular screening. This leads to an increase in market demand for medical devices and consumables. According to a market analysis report published by Fortune Business Insights, the global market volume of medical devices and consumables is expected to grow at a CAGR of 5.9% from $536.12 billion in 2023 to $799.67 billion by 2030. The US is the world's leading manufacturing country of medical devices and the world's largest market of medical devices and consumables. In the rankings of the “World's top 10 pharmaceutical companies” and “World's top 10 medical device companies”, the US accounts for the largest share with four and seven companies respectively. China follows in the second place. China's market of medical devices and consumables is facing both challenges and opportunities with the continuous promotion of centralised VBP (volume-based procurement) and DRG (diagnosis related groups) medical insurance reform. As a result, there is high potential to grow in innovative medical devices and high-value consumables. Continuous breakthrough in material science and processing technology is crucial to the development of medical device, equipment, consumables and pharmaceutical packaging. Polymers are biocompatible, durable, easy to process and stable in quality, contributing to the user-friendly design and safety of medical products. Interventional cardiology: PLCL and UHMWPE materials shine Interventional cardiology device is the largest sector of high-value medical consumable, accounting for more than 30% of the market. Mid- to high-end products are mainly manufactured by foreign manufacturers, such as Medtronic, Johnson & Johnson, and Boston Scientific. The sector mainly includes stents, pacemakers and valves. The main materials of these consumables are nickel-titanium alloy, cobalt-chromium alloy, medical-grade high molecular weight poly(L-lactide-co-caprolactone) (PLCL), and ultra-high molecular weight polyethylene (UHMWPE). Beijing Advanced Medical Technologies cooperates with Department of Material Science of Fudan University to develop PLCL 95/5 polymer. The Chinese company also teams up with Beijing Anzhen Hospital and Beijing Jishuitan Hospital to conduct research on the new generation of absorbable PLCL coronary stents. The high-end UHMWPE fibre product market is dominated by companies including DSM, Honeywell, and Toyobo. For example, Honeywell's Spectra MG medical grade fibres are made of UHMWPE fibre with a patented gel spinning production process. UHMWPE manufactured by Chinese companies are mainly mid- to low-end products. Orthopaedics: PEEK, PU, and PMMA are the material of choice In addition to interventional cardiology device, orthopaedic device has also become a fast-growing segment of medical device applications in recent years. The high age-related incidence of orthopaedic diseases is the major contributor, resulting in the increased demand for orthopaedic device in elderly population. As one of the largest segments in the medical device industry, the orthopaedic device segment consists of two parts: orthopaedic implantable devices and specialised surgical instruments, with the former account for 90%. Orthopaedic implantable devices mainly include craniofacial and maxillofacial implants, spinal fusion interbody cages, joint implants, fixation plates, and screws. Apart from titanium alloy and stainless steel, commonly used materials are Polyether ether ketone (PEEK), polyurethane (PU) and polymethyl methacrylate (PMMA), etc. Complying with the clinical standards, these implantable materials cannot be rejected by the human body and do not produce harmful matters. Meanwhile, these materials must be able to produce optimal structures at an affordable price. The stiffness of PEEK closely matches with human bone and the polymer has the properties of radiolucency and reduced stress shielding. As such, PEEK has high market potential in medical applications and is mainly used in the manufacture of spinal and joint implants. Curiteva, US-based technology and manufacturing company has developed a spinal implant made of Evonik VESTAKEEP i4 3DF PEEK filament biomaterial. The 3D-printed implant received clearance from the FDA and it is the first such device for commercial use. The PEEK spinal cage implant developed by Bond3D in the Netherlands is translucent under X-ray or CT scans. It allows bone ingrowth, provides a secure fit and can reduce production cycle. Tangdu Hospital of Air Force Medical University in China created skull, sternal and rib implants with PEEK, using INTAMSYS’ 3D printing equipment. Drug delivery: COC and PC+ABS optimise user-friendliness Like orthopaedic devices, drug delivery devices are growing rapidly. Allied Market Research forecasts the market of global drug delivery systems to grow at a CAGR of 16%, achieving a market volume of approximately $195.1 billion by 2030. Drug delivery devices are mainly used to protect drugs from environmental contamination to ensure safe implementation of drugs. The main product types include implantable, mucosal, injecting devices, etc. Medtronic has introduced an infusion set for insulin infusion that can be worn for up to seven days for patients with diabetes, while infusion sets on the market typically need to be replaced every two to three days. Medtronic says that the infusion set can save up to 25% of insulin costs and reduce plastic waste by up to 50% on a yearly basis. SCHOTT Pharma uses advanced cyclic olefin copolymer (COC) to make prefilled syringes (PFS) that can be stored at ultra-low temperature of -100°C. The syringes are fracture-resistant, biologically inert and of superior barrier property to ensure drug stability. Beijing QS Medical Technology has optimised the design of its insulin needle-free syringes with Covestro's environmental friendly, flame-retardant polycarbonate and acrylonitrile-butadiene-styrene copolymer blend (PC+ABS), which is designed to make the product structure more robust and reliable. Medical packaging: Plastic bottle and blister packaging grow The boom in medical devices and consumables has led to the growth of the medical packaging market. According to Future Marketing Insights, the global medical packaging market is expected to reach $12.4 billion in revenues in 2023, and it will grow at a CAGR of 6.1% to reach $20.9 billion by 2033. The medical packaging market in China is expected to reach $12.7 billion in 2033. At present, pharmaceutical packaging is developing in four major directions: patient-led demand packaging design, rising demand for plastic bottles and blister packaging, attention to child safety and sustainability. The plasticisation of oral solution bottle packaging is one of the emerging trends in the transformation of pharmaceutical packaging. For example, Berry Global launched a plastic alternative for oral solution bottle packaging. Compared with glass bottles, the plastic bottle not only saves the material costs, but also reduces production costs by eliminating the complex processes required for manufacturing traditional glass bottles, such as bottle blowing, bottle washing and light inspection. Such bottles are easy to transport as well. Elkem's Silbione series of medical silicone rubber materials and Polyplastics' medical-grade polyoxymethylene (POM) can be used to make drug delivery systems. Medical equipment: Demand for functional plastics on the rise In addition to the above-mentioned medical devices and consumables, soft and rigid endoscopes, CT, MRI, ultrasound, ventilators, anaesthesia machines, hemodialysis machines, and other medical equipment have become development focus for the medical plastics industry in recent years. Röchling has developed POM, PEEK, Polyethylenimine (PEI) and glass-filled nylon (PA+GF) materials that can be used to manufacture ventilator shells, valves, switches, guide rails, sockets, adapters, cylinders, clamps and other components. Besides, Röhm’s high-performance Cyrolite acrylics, which are ultra-high transparency and excellent sterilisation resistance, are easy to be processed into precision parts. They can be used for dialysis equipment and other medical devices and consumables in contact with blood, vitro diagnostics, surgical lighting, as well as a wide range of applications from the intensive care unit to the general operating room and laboratories. INEOS Styrolution's acrylonitrile-styrene-acrylate (ASA) polymer "MED" is designed for small medical devices in homes and hospitals. It has excellent chemical resistance, UV resistance and impact strength. Amcor China has launched mono-material recyclable packaging AmPrima and transparent sterilisation-resistant high-barrier recyclable packaging material AmLite, which were designed based on recyclability guidelines for flexible packaging. Medical packaging manufacturer Nelipak uses Eastar Renew 6763, Eastman's recycled copolyester, to manufacture rigid thermoformed sterile barrier packaging. Advanced processing and automation reduce cost and increase efficiency High-quality manufacturing of medical devices and consumables cannot be achieved without precision processing and moulding. The 32-cavity injection moulding machine of Fanuc for producing medical needle tubes has a screw diameter of 48mm, the cycle time is 11.75 seconds; LKIMM’s EL 130 injection moulding machine, which is suitable to produce pipette tips, uses non-contact tie bar and has a mould clamping position control accuracy of 0.01mm. Jwell Machinery’s twin-screw drying-free PET medical packaging material production line can effectively reduce the viscosity of PET resin; Gowin Precision Machinery adopts the pre-filled series of multi-cavity precision moulds, which improve the yield of molecular diagnostic kit products. In addition to moulding, the production of medical devices and consumables also includes inspection, testing, packaging, and storage. With the development of Industry 4.0, automation technology has gained wider application in production processes, helping manufacturers to reduce production costs and improve operating efficiency. Shanghai Mitrassist Medical has realised fully automated industrial production of bioprosthetic valves, which originally required more than 2,000 stitches by hand, lowering the cost of the transcatheter aortic valve replacement (TAVR) system made of high molecular materials from RMB 40,000-50,000 to less than RMB 1,000. Hunan Vathin Medical Instrument has designed an automated assembly line for endoscopes, enabling annual production capacity of up to 400,000 units while reducing costs by nearly 30%. APON Corporation, based in Jiangsu, has adopted an automated production line for its nasal hygiene products, enabling an annual production capacity of up to 10 million bottles. Besides, the blood collection needle automated production line introduced by Maider, a specialist in automation equipment in consumables, effectively solves the bottlenecks of complicated components/processes, low efficiency of manual assembly, high risk of contamination, and unstable quality. Positive response to health concerns Innovation in medical devices, consumables, equipment and pharmaceutical packaging is not only technological progress, but also a positive response to global health concerns. Thanks to their material and processing advantages, polymer materials not only improve safety, but also enhance the patient experience and promote the sustainable development of the medical industry. With the continuous iteration in the industry, the future of medical polymer materials and related processing is promising.

While currently available PCSK9 inhibitor medications to lower cholesterol must be administered every few weeks by injection, a new, investigational PCSK9 inhibitor called recaticimab safely lowered bad cholesterol more than 50% when injected every 1-3 months, depending on dose. A new PCSK9 inhibitor (recaticimab) injected every one to three months may work safely and provide more flexible dosing to lower cholesterol, according to late-breaking science presented today at the American Heart Association's Scientific Sessions 2023. The meeting, Nov. 11-13, in Philadelphia, is a premier global exchange of the latest scientific advancements, research and evidence-based clinical practice updates in cardiovascular science. "Previous studies found that 30% to 40% of people discontinued their current PCSK9 therapies, given every two to four weeks, during or after six months of beginning treatment. More flexible dosing with recaticimab, given up to every 12 weeks, might increase the proportion of people with high levels of bad cholesterol to stick with their recommended treatment to lower bad cholesterol levels and reduce risk of heart disease," said lead study author Xin Du, Ph.D., a professor of cardiology at Beijing Anzhen Hospital and the Capital Medical University in Beijing, China. The current study, Recaticimab Add-On Therapy in Patients With Non-Familial Hypercholesterolemia and Mixed Hyperlipidemia or REMAIN-2, examines the safety of a new PCSK9 inhibitor, recaticimab, and its ability to lower bad cholesterol when given at different doses and intervals to people with non-genetic forms of high cholesterol. American Heart Association guidelines indicate a cholesterol target of less than 100 mg/dl in most adults and less than 70 mg/dl in high-risk people who have already had a heart attack, or stroke or have genetic forms of high cholesterol. When cholesterol-lowering statin medications and other treatments are not effective in reducing bad cholesterol to target levels, physicians may often add a PCSK9 inhibitor. The medication binds to and inactivates a protein on cells found in the liver to lower bad cholesterol. Current FDA approved PCSK9 inhibitors include alirocumab and evolocumab, which are injected every 2-4 weeks. This multicenter study in China involved 689 participants with abnormally high levels of bad cholesterol despite ongoing moderate or high intensity statin therapy. Participants were divided into three groups: one received either 150 mg of recaticimab or a placebo injection every 4 weeks; one group received 300 mg of recaticimab or placebo injection every 8 weeks; and one group was given 450 mg of recaticimab or placebo injection every 12 weeks. The study found: "Since all the doses and frequencies had similar effectiveness and safety, this may someday provide patients and physicians with more flexible options," Du said. In the study's secondary findings, other types of lipids associated with atherosclerotic heart disease were also reduced significantly in the recaticimab groups compared to the placebo groups, including: "Recaticimab reduced these key lipid parameters by a similar magnitude to other PCSK9 inhibitors, providing further evidence of profound benefits with the treatment despite less frequent dosing," Du said. Trial background and details: Although there are several statin medications, all participants in this study were taking either atorvastatin or rosuvastatin, so the impact of adding recaticimab to other statins may differ, researchers note. In addition, because the study was conducted in China, where a higher proportion of people often have increased rates of reactions and intolerance to statin treatment, more of the participants were on moderate rather than high intensity statin therapy, and the results may not be generalizable to other populations. In addition, changes in laboratory measures in this study suggest but do not demonstrate that recaticimab add-on treatment may lower rates of heart attack and stroke, Du said. "Further studies will be conducted to explore the possible benefits of recaticimab in reducing cardiovascular risk," Du said. In addition, a separate trial, REMAIN-3, is being completed to determine whether recaticimab reduces bad cholesterol in people who have one gene for familial hypercholesterolemia, a genetic disorder that causes high low-density-lipoprotein cholesterol and increases the risk for developing heart disease or having a heart attack at a younger age. Co-authors, disclosures and funding sources are listed in the abstract. The study was funded by Jiangsu Hengrui Pharmaceuticals. Statements and conclusions of studies that are presented at the American Heart Association's scientific meetings are solely those of the study authors and do not necessarily reflect the Association's policy or position. The Association makes no representation or guarantee as to their accuracy or reliability. Abstracts presented at the Association's scientific meetings are not peer-reviewed, rather, they are curated by independent review panels and are considered based on the potential to add to the diversity of scientific issues and views discussed at the meeting. The findings are considered preliminary until published as a full manuscript in a peer-reviewed scientific journal. The Association receives funding primarily from individuals; foundations and corporations (including pharmaceutical, device manufacturers and other companies) also make donations and fund specific Association programs and events. The Association has strict policies to prevent these relationships from influencing the science content. Revenues from pharmaceutical and biotech companies, device manufacturers and health insurance providers and the Association's overall financial information are available here.