Kosel Medical and Medtronic Forge Strategic Partnership to Advance Seledora® Coronary Scoring Balloon in Complex PCI
Kossel
Vascular Interventional Device Manufacturer and R&D Developer
Medtronic
Medical Device Manufacturer
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Recently,Kossel Medtech (Suzhou) Co., Ltd(abbreviation "Kossel") andMedtronicStrategic Cooperation Signing Ceremony Held in Suzhou.
According to the information disclosed by both parties, this cooperation will focus on Kossel Medtech's subsidiaryMixen Medical Technology (Suzhou) Co., Ltd.The core product——Seledora®Coronary Artery Spur Balloon Dilation CatheterExpand to establish a long-term collaborative mechanism in multiple areas such as product promotion, academic exchange, and clinical application.
Against the backdrop of continuously growing demand for coronary intervention treatments and increasing complexity of lesions, this collaboration is seen within the industry as a deep integration of the system capabilities between locally innovative device companies and multinational medical technology enterprises. The focus is not only on the commercial cooperation of a single product but also on how both parties can promote the standardized application of innovative technologies in real-world settings through synergy.
At the signing ceremony, Yu-shao Gu, Global Senior Vice President of Medtronic and President of Greater China, and the founder of Kossel MedtechCEO Hu Qing, Tao Jia, Vice President of Coronary and Renal Denervation Business Operations at Medtronic China, Pan Xingzhen, Executive President of Kossel Medtech, Zhou Quan, Vice President of Strategy, Industrial Cooperation, and Digital Innovation at Medtronic Greater China, and Wang Zhi, General Manager of Mixin Medical, attended and witnessed the official launch of the collaboration.
At the signing ceremony, both parties' management expressed their views on the changes in China's medical system, the value of local innovation, and long-term cooperation.
Medtronic Global Senior Vice President and Greater China President Yu-Shao Guindicates that the Chinese medical system is undergoing a transformation fromThe shift from "whether there is" to "how good, how stable, and whether it is sustainable" has made China one of the most valuable healthcare innovation landscapes globally. Throughout this process, Medtronic has adhered to an innovation path "centered on local needs," emphasizing that innovative technologies must genuinely integrate into clinical practice in China.
Founder andCEO Hu QingIt was pointed out that the lack of stable and widely applicable solutions for complex coronary cases is the core driving force for enterprises to continuously invest in research and development. In his view, truly valuable innovation not only requires technical feasibility but also needs to achieve standardized application and long-term validation through a mature system.
# Product Introduction:Seledora® Coronary Artery Spur Balloon
Seledora® Coronary Artery Spur BalloonIt is an innovative product developed by Kossel's subsidiary, Kossel Medtech (Suzhou) Co., Ltd.Yu 2025Year3Month14Day Obtained the approval from the National Medical Products Administration (NMPA) Approved for marketing (Registration No.: GXY ZZ20253030586）。
Core Technology and Innovative Design
Seledora® The design of the coronary artery spiny balloon breaks through the limitations of traditional balloon expansion technology, with its balloon surface equipped with3 strips with a height of0.42mm Triangular nylon棘突prisms, evenly spaced 120° Distribution, forming a unique棘突structure. This design enables the balloon to expand the lesion plaque orderly through the focused pressure of the棘突components during the expansion process, avoiding the irregular dissection and blood flow restriction phenomena that may occur in traditional balloon treatments.
Seledora® The棘突组件not only provides precise mechanical force during plaque expansion but also offers unique advantages in handling moderate to severe, especially circumferential calcified lesions. Other traditional devices often encounter difficulties when facing these types of lesions, whereasSeledora® By utilizing its thorn-like components that can embed into plaques, it allows for low-pressure expansion and gradual vessel opening, creating conditions for subsequent further lumen modification and maintenance, thereby achieving...“Precision Preprocessing”。
Product Performance and Advantages
Precision Expansion：Similar to traditional pre-dilation balloons,Seledora® Has0.0165" The outer diameter is imported, maintaining good passability and catheter compatibility. Its unique triangular nylon棘突can not only effectively break up lesion plaques but also precisely target the dilation area, avoiding irregular dissections.
Low-pressure dilation, reducing risks：Seledora® The coronary artery spiny balloon, through low-pressure expansion technology, performs precise treatment at the lesion site, greatly reducing potential damage to the vessel wall during traditional expansion. It has a significant advantage in treating calcified plaques.
Wide Application：Seledora® Not only suitable for moderate to severe calcified lesions, but also capable of addressing various complex coronary artery diseases, becoming an effective tool for handling refractory lesions.
Optimize Subsequent Treatment：Through the subsequent drug-releasing stent (DES) and Drug-Coated Balloon (DCB) Optimize lumen morphology,Seledora® Significantly reduce the risk of postoperative restenosis, laying the foundation for long-term efficacy.
Clinical Validation and Safety
According to a prospective, multicenter, randomized controlled non-inferiority clinical trialResult,Seledora® The immediate lumen gain of the coronary artery棘突球囊 (textural issue detected, assuming it refers to a specific balloon type like "spiked balloon") was not statistically different from the control group, and the safety and secondary efficacy evaluation results of the experimental group were also comparable to the control group.
The trial demonstrated that,Seledora® With clinical effects comparable to traditional methods, while offering significant safety advantages. The trial data further supports this.Seledora® Application Prospects in the Treatment of Complex Lesions.
Specifications and Scope of Use
Seledora® Coronary Artery Spur Balloon Utilizes Low-Pressure Focused Expansion Technology, Particularly Suitable forPatients with Moderate to Severe Coronary Artery CalcificationThe treatment. It can orderly tear the plaque during the expansion process, ensuring the treatment effect while reducing the pressure on the blood vessel wall and avoiding harm to healthy blood vessels.
This product is particularly suitable for precise pre-dilation during the treatment process, providing favorable conditions for the subsequent application of drug-eluting stents or drug-coated balloons, thereby improving overall treatment outcomes and reducing complications.
# Company Profile:Kossel Medical and Mixin Medical
Kossel
Kossel Medtech (Suzhou) Co., Ltd was founded in2013 Year, headquartered in Suzhou City, Jiangsu Province, dedicated toHigh-end Vascular Interventional DevicesAnd the research, production, and sales of treatment solutions.
As an innovative medical device company, Kossel focuses on the field of vascular intervention, particularly the development of coronary and peripheral vascular treatment devices. Its core technology continuously breaks through traditional treatment bottlenecks, driving innovation in medical technology.
Mixen Medical
A subsidiary of Kossel MedtechKossel Medtech (Suzhou) Co., Ltd., focusing onCoronary Intervention ProductsResearch and Development and Promotion.
Since its establishment, Mixin Medical has relied on advanced technology and a research and development system to launch multiple innovative products, successfully entering both the Chinese and international markets. The company has continuously increased its investment in product development, obtaining numerous domestic and international invention patents, and achieving remarkable results in clinical applications.
Mixen Healthcare not only focuses on the Chinese market but also actively promotes its globalization strategy.2021At the end of the year, Mixin Medical acquired Medtronic in the United States.Micell Ireland, a biomedical company focused on the research and development of interventional medical devices. Through this acquisition, Mixin Medical further expanded its international market presence and strengthened its competitiveness and technical capabilities on a global scale.
# The Core of Strategic Cooperation: Not"Introduction" but "Collaboration"
From the information disclosed by both parties, this cooperation is not a simple product agency or channel partnership, but rather focuses onSeledora® Products, establish a more systematic collaboration mechanism.
According to the plan, the two parties will carry out cooperation in the following dimensions:
Product Promotion and Market Access Synergy
Academic Exchange and Standardized Application Support
Real-world Clinical Feedback and Continuous Optimization
For Kossel Medtech, leveraging Medtronic's mature market network and academic promotion system helps enhance the accessibility of innovative products across different levels of medical institutions, accelerating the process from..."The Transformation Process from 'Approval for Marketing' to 'Stable Application'."
For Medtronic, collaboration with local innovative enterprises helps to supplement and improve the existing solution portfolio, providing a richer set of technical options for the treatment of complex coronary artery disease and better responding to the evolving clinical needs in China.
# Conclusion
As coronary intervention treatment moves towards complexity, multi-device integration, and precision, the collaboration between local innovation and the global system is becoming a significant driving force for industry advancement.
From a broader perspective, the cooperation between Kossel and Medtronic also reflects an important trend in the current development of China's medical device industry.
As the regulatory system matures, clinical needs upgrade, and the technical capabilities of local enterprises improve, an increasing number of innovative medical devices produced in China are now qualified to enter mainstream clinical systems. At this point,How to achieve standardized promotion, large-scale application, and continuous iteration through appropriate collaboration models has become a new key issue.。
The experience accumulated by multinational medical technology companies in system building, clinical education, and long-term services, combined with local companies' close understanding of clinical needs, is forming a new complementary relationship. This collaboration focuses onSeledora® The cooperation is a concrete practice under this trend.
Kossel's Strategic Cooperation with Medtronic: Starting with an Innovative Device Already Approved for Market
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