Home Agency, Acquisition, and In-house R&D: The Emerging Blue Ocean of Carotid Stenting Heats Up

Agency, Acquisition, and In-house R&D: The Emerging Blue Ocean of Carotid Stenting Heats Up

Jul 25, 2025 17:47 CST Updated 17:47
Medtronic

Medical Device Manufacturer

Contego Medical

Developer of Thrombosis Protection Devices

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Heart Future

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.

Compared with traditional filters and mesh-covered stents,Neuroguard Stent SystemThe aperture has been reduced by 3-4 times.Doctors can precisely adjust the filter according to the specific anatomical structure, effectively preventing particles from bypassing the filter and ensuring the safety and efficacy of the treatment.
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The Neuroguard stent has a shorter landing zone, which makesThe system is suitable for more than 94% of patient anatomical structures.. ItCanTwo types of stents are provided.——Closed-hole stent and open-hole stent.Obturator StentExpandPresentHighly adaptable, it demonstrates excellent performance in both short-term and long-term durability, with no incidence of thrombosis, no clinically-driven target lesion revascularization, and an extremely low restenosis rate within one year.

Boston Scientific
Boston ScientificWALLSTENT is the first generation of self-expanding carotid artery stents., is another closed-loop stent in the carotid artery stent category besides XACT. The stent can still be retrieved and repositioned after 50% release. With a mesh size of 1.08 square millimeters, it is currently the stent with the smallest mesh area available on the market in China and is also the only stent approved by the FDA for treating bilateral carotid arteries.
The Silk Road Medical acquired by Boston Scientific has developed a method namedMinimally Invasive Surgery of Transcarotid Artery Revascularization (TCAR), used to prevent strokes in patients with carotid artery disease.
During the surgery, a specialized sheath is placed in the artery, and the sheath is first connected to the flow reversal system, which protects the brain throughout the procedure.Flow reversal is provided by the Enroute Transcarotid Neuroprotection System (TACR System).Temporarily diverting arterial blood flow from the brain, through a filter, and back into the leg veins to protect the brain from harmful debris.
The TCAR system was approved by the U.S. FDA in 2015 and has been proven to reduce the risk of stroke.
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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.

In January 2025, Contego Medical announced Neuroguard IEP®The system's PERFORMANCE II trial study is a prospective multicenter study evaluating the safety and effectiveness of the system. A total of 305 patients participated, involving 32 centers in the United States and Europe.The primary endpoint of the study isComposite endpoint of major adverse events, defined as death, all types of stroke, and myocardial infarction within 30 days post-operation, and ipsilateral stroke followed up to 12 months.
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Postoperative 30 Days:Minor stroke occurred in 4 cases, accounting for 1.3%; no major stroke occurred, with 1 case of cardiac death; stroke/mortality rate was 1.6%; stroke/mortality/myocardial infarction rate was 2.3%.At 12 months post-operation:No major stroke, clinically-driven target lesion revascularization, stent thrombosis, or neurological death occurred. During the 30 days and 12 months,The incidence of all strokes and ipsilateral strokes is 1.8%.

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.


# Chinese Brands Break Through with Strength

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 ChannelAdopting 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.

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# From Profit Highlands to Price Battlefields

In November 2024, the National Medical Products Centralized Volume-based Procurement Announcement (No. 2) for cochlear implants and peripheral vascular stents was officially released. The procurement cycle for these medical devices is three years, calculated from the actual implementation date of the selection results in each regional alliance.

This volume-based procurement document has turned the once high-value peripheral vascular stent sector into the focal point of a price war.

The maximum declared price for lower limb arterial stents is set at 5,500 yuan per unit, while that for carotid artery stents is 6,000 yuan per unit.. This price not only significantly compresses the profit margin of enterprises but also directly leads to the elimination of many small and medium-sized businesses.
The centralized procurement policy requires winning bidders to have sufficient production capacity and a robust supply chain resilience. This undoubtedly sets an invisible threshold for small and medium-sized enterprises, excluding them from the centralized procurement system. "Survival of the fittest" has become inevitable. How can companies remain invincible in this turning point of fate?
Although low-price competition has reduced the burden on patients in the short term, it has also forced companies to cut their R&D budgets. Data shows that after a domestically produced stent brand won the centralized procurement bid, its profit margin dropped from 25% to less than 10%, and its R&D investment ratio decreased by 30% accordingly. The question is:Who will bear the cost of innovation? If the industry only focuses on cost and neglects technological advancement, how can the future level of medical care be guaranteed?
Large enterprises quickly seize the market by leveraging their advantages in capital, production, and service capabilities, while small and medium-sized enterprises struggle to survive in the cracks. This battle is pushing the peripheral vascular stent industry into an unprecedented stage of centralization. Under the dual pressures of price and scale, small enterprises with limited resources find it difficult to meet the requirements of full lifecycle services.Is it time to choose transformation, exit, or seek new survival strategies?
In the context of centralized procurement, economies of scale become crucial for cost reduction.For enterprises, the choice between "mergers and acquisitions" and "in-house R&D" is a matter of life and death for the future.Mergers and acquisitions can quickly integrate resources, gaining production capacity and market channels. Technological innovation is the cornerstone of a company's core competitiveness, and self-research ensures a company’s initiative in future technological changes.Companies need to find the optimal balance between "small mergers and acquisitions + in-house R&D" to achieve short-term market expansion while ensuring technological upgrades.
The peripheral vascular stent industry is at a critical juncture of transformation. The centralized bulk procurement has brought pressure, but it also provides an opportunity for the industry to reshape itself. Only by enhancing product competitiveness through innovation, expanding the market with professional strength, and strategically planning for globalization can enterprises survive in this fierce competition, and even achieve rebirth.



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Structural Heart Disease  → ▌Medtronic
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Heart Failure  Core Medical
Arrhythmia → ▌Aikema Medical
Vascular Puncture and Closure → ▌Contego Medical
Research and Development and Clinical Trial Support → ▌Contego Medical


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