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The carotid artery is a key channel for blood delivery to the brain, and its degree of stenosis is closely related to the risk of stroke. Approximately 30% of ischemic strokes are caused by carotid plaque stenosis.
In the population aged 50 to 60, 5 out of every 1,000 people suffer from severe carotid artery stenosis, and in those over 80 years old, this proportion rises to 10%. This shows that carotid artery stenosis is relatively common and poses significant risks among middle-aged and elderly populations.
However, widely applied on a global scaleThe number of carotid artery stent products is limited, with only about 10 products currently available.`, and most of them are first-generation products that have been in service for nearly 20 years, such as Abbott's Acculink, Medtronic's Protege, Cordis' Precise, and Boston Scientific's Wallstent, etc.`
In the Chinese market, no domestically produced carotid artery stents have been approved for marketing.
In January 2025, Medtronic announced an agreement with Contego Medical,Medtronic to Be Exclusive Distributor of Contego Medical’s Commercial Product Portfolio in the U.S. MarketContego Medical's products are mainly used for revascularization treatment of carotid and peripheral vascular diseases. The scope of this agreement includes obtaining approval from the U.S. FDA.Neuroguard IEP All-in-One Carotid Stent System。
In September 2024, the U.S. publicly traded company proposing Transcarotid Artery Revascularization (TCAR)Silk Road Medical Acquired by Boston Scientific for Up to $1.16 Billion in Premium DealThe world's only commercially available device for TCAR minimally invasive surgery, developed by Silk Road Medical——ENROUTE®Transcarotid Neuroprotection System, has also been incorporated into Boston Scientific's portfolio.
April 2024,Suzhou Zhongtian Medical Device Technology Co., Ltd.Self-developed Carotid Artery Stent SystemContego Medical®Has passed the review and becomeThe First Domestically-Produced Carotid Artery Stent to Enter the Innovative Medical Device Special Review in China。
This shows that in the field of neurointervention, compared to the highly competitive markets for acute ischemia and access products such as coils, intermediate catheters, intracranial balloons, and thrombectomy stents,The field of arterial stenosis has enormous demand, but the competition is not yet saturated, offering vast room for innovation, undoubtedly making it the next frontier in the neurointerventional space."Blue Ocean"。
# The Battle of the Two Giants
Stent selection has always been a topic of debate in carotid artery stenting (CAS).
Carotid artery stents can be divided into two types: balloon-expandable and self-expanding, among whichSelf-expanding stents are the mainstream in clinical applications.Depending on the stent structure, it can also be divided based on whether the stent mesh area is >7 mm².Open-loop and Closed-loop Stents. Both open-loop and closed-loop stents have their own advantages, and the principle of choosing a stent in clinical treatment is to select the appropriate stent form based on the lesion condition. For example, compared with closed-loop stents, open-loop stents have better compliance and can adapt more easily to tortuous vessels, offering superior flexibility.
Medtronic
Medtronic has a long-standing presence in the carotid artery stent market.
In 2005, the FDA approved Medtronic's Protégé RX self-expanding carotid stent, which was launched in China in 2006;紧接着 in 2009, the Spider FX™ distal thrombus protection device entered China.The strategic agreement with Contego Medical is expected to transform revascularization treatments in the field of carotid and peripheral vascular diseases.。
Contego Medical found that many studies have pointed out that, in the debris released during the stent implantation procedure, up to70%-90% of the fragment diameters are less than 100 micrometers., such tiny fragments can easily pass through the larger pore size of traditional distal filters.旗下的Neuroguard Triple-Function Carotid Artery StentAdopted Contego Medical's unique Integrated Embolic Protection (IEP) technology, integrating an embolic protection filter equipped with 40μm micropores onto a 6Fr balloon catheter, combining the carotid artery stent, embolic protection filter, and balloon catheter into one unit, reducing the frequency of catheter exchanges.
As of 2023,Silk Road Medical has successfully completed over 25,000 TCAR procedures in the United States, with the global cumulative total exceeding 100,000., is rapidly becoming a new alternative to traditional carotid endarterectomy (CEA) and carotid artery stenting (CAS). CompanyAchieved sales of $177.1 million throughout 2023, representing a 28% increase compared to 2022, demonstrating strong market growth potential.
In March 2024, Silk Road signed an exclusive distribution cooperation with Jianshi Medical,Gynex Medical Introduces Contego Medical's Innovative TCAR Technology and Core Products to the Chinese Market, further expanding its global influence.
The widespread application of TCAR surgery undoubtedly presents certain challenges and pressures for Medtronic in advancing the commercialization of Neuroguard. However, Neuroguard has demonstrated superior clinical data, showing a lower risk of stroke caused by emboli compared to Silk Road's TCAR technology.。
Whether the early starters continue to lead, or the latecomers catch up, or all parties advance together remains to be seen.Including technological advancements, market promotion, patient acceptance, and continuous validation of clinical data.Continuous optimization and innovation of core products,Ultimately, more patients with carotid artery stenosis will benefit, providing them with higher-quality treatment options.
Currently on the market in ChinaThe first-generation carotid artery stents had larger mesh openings, which could easily lead to plaque detachment and stroke after surgery.; Stents manufactured using laser cutting technology may have struts protruding into the vessel wall after deployment in tortuous vessels, potentially leading to risks such as thrombosis.
The second-generation carotid artery stent, while reducing the mesh size of the stent, has relatively poor deliverability for double-layer stents., which requires the use of a larger diameter delivery catheter, increasing intraoperative vascular irritation.
Suzhou Zhongtian MedicalContego Medical®Carotid Artery Stent as the First Domestically Produced Carotid Artery Stent in China to Pass Through the Innovative Green Channel,Adopting both domestic and internationalFirst-of-its-kindSingle-layer microporous hybrid weaving technology, with a mesh area only 1/30 that of traditional cut stent mesh., effectively avoiding the risk of delamination in dual-layer stents while increasing plaque coverage.
Compared with traditional braided stents,Contego Medical®Carotid Artery StentWith stronger radial support; compared with laser-carved stents, it has lower chronic outward force; fully utilizes the superelastic strain hysteresis energy storage characteristics of nitinol to ensure effective dilation of stenosis while avoiding excessive stimulation to blood vessels.
In addition,This product is the first to feature a protective film on the surface of carotid artery stents.,Significantly reduce nickel ion release, enhance product corrosion resistance and biocompatibility, and further improve patient benefits.
# From Profit Highlands to Price Battlefields
This volume-based procurement document has turned the once high-value peripheral vascular stent sector into the focal point of a price war.
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