Kossel Medical has recently achieved a string of overseas regulatory wins, securing market approvals for multiple products in Japan, the United States, Singapore, Vietnam and Hong Kong SAR. Spanning coronary, peripheral and neurointervention segments, several product lines have delivered simultaneous breakthroughs in key international markets, further accelerating the company’s global footprint.
Industry Clinical Co development: SPEQTA® Microcatheter Receives First ever Approval in Japan
SPEQTA® Microcatheter has recently obtained market approval in Japan. This marks Kossel’s first ever approval for a neurointerventional product in Japan and signals the substantive overseas launch of its neurointervention business.
Developed through joint collaboration between Kossel and Japanese clinicians, the product’s design concept originates from real world front line clinical demands in Japan. More than simply a product for export, it represents two way innovation that translates clinical needs into product development. Building on this milestone, Kossel will continue to deepen such partnerships, convert front line clinical insights into driving forces for product iteration, and deliver better suited medical devices for the Japanese market.
Sequential Market Authorizations Accelerate Global Footprint Expansion
Singapore: Falexpand® HP PTA Balloon Dilatation Catheter obtains Singapore medical device registration
Vietnam: Selestem® Single use Radial Artery Tourniquet obtains Vietnamese medical device registration
Hong Kong SAR: Selethru® PTCA Balloon Dilatation Catheter and Selethru® NC PTCA Balloon Dilatation Catheter obtain Hong Kong SAR medical device registrations
These multi market approvals further strengthen Kossel’s coronary and peripheral product portfolios across regional and major international markets. They lay a solid foundation for deepening presence in ASEAN and expanding into North America, speed up Kossel’s global outreach, and enable high quality Chinese made vascular interventional devices to benefit more patients worldwide.
These successive market authorizations consolidate the overseas layout of Kossel’s core coronary and peripheral product lines, while delivering new progress in its neurointervention business. This achievement reflects Kossel’s integrated industrial chain capabilities and global operational expertise. Guided by its “Local Base, Global Reach” international strategy, Kossel will keep advancing overseas regulatory submissions and commercialization, steadily expanding key global markets, and bringing premium Chinese manufactured medical devices to more healthcare institutions and patients.
Kossel Medtech (Suzhou) Co., Ltd.(“Kossel Medtech”) and Shanghai Rongmai Medical Technology Co., Ltd. (“FuseMedTech”) have officially established a strategic partnership. Both companies will deliver comprehensive integrated solutions for peripheral vascular intervention, fostering deep collaboration across global commercialization, clinical program development and technological innovation.
Strategic Alignment to Expand Clinical Access for Peripheral Vascular Implantable Interventional Devices
FuseMedTech specializes in vascular interventional device development, addressing unmet clinical needs through continuous innovation. Its product portfolio is anchored by the FuseVive® Pulmonary Artery Thrombectomy System, covering peripheral vascular embolism, peripheral thrombus removal and hepatic interventional procedures. Drawing on Kossel Medtech’s well‑established commercial channels, clinical education and regulatory access capabilities, FuseMedTech’s innovative domestic devices will reach broader patient populations living with peripheral vascular disease worldwide.
FuseSuper® Peripheral Fibered Embolization Coil (Push able Coil)
Manufactured in‑house by Shanghai Xiaoyu Medical Technology Co., Ltd. (“Xiaoyu Medical”), a wholly‑owned subsidiary of FuseMedTech, the FuseSuper® Peripheral Fibered Embolization Coil (Push‑able Coil) is China’s first domestically‑manufactured push‑able peripheral fibered embolization coil granted marketing clearance by the NMPA.
– Constructed with platinum tungsten alloy and dense fibers, the device delivers excellent radiopacity, MRI compatibility and biocompatibility.
– Offered in 0.018‑inch and 0.035‑inch delivery systems. A comprehensive size and shape portfolio meets diverse clinical demands. Its unique bi‑hemispherical geometry lowers push‑resistance and minimizes vessel trauma for enhanced procedural safety.
– Proprietary loading and delivery hardware improves handling stability, optimizes coil‑catheter docking, and boosts reliability during coil deployment.
FuseEasy® Peripheral Detachable Fibered Embolization Coil System (Controlled Deployment Coil)
FuseEasy® is Xiaoyu Medical’s flagship peripheral interventional system, indicated for embolization of peripheral aneurysms, arteriovenous fistulas, arteriovenous malformations and other peripheral vascular lesions.
– It adopts an innovative dual‑latch mechanical detachment design for secure connection. Push, retraction and repositioning are permitted prior to deployment, enabling precise, controlled deployment and reducing the risk of unintended premature detachment.
– Variable‑diameter multi‑segment push wire with PTFE coating balances column strength and trackability. It maintains reliable push‑and‑pull performance within tortuous, complex vasculature to streamline workflow.
– Supports both 0.018‑inch and 0.035‑inch platforms, with 2D, Cross and 3D coil configurations across 98 total configurations. It addresses the full embolism workflow: target vessel occlusion, aneurysm basket framing, dense packing and final contour filling, delivering versatile options for peripheral embolization cases.
FuseVive® Pulmonary Artery Thrombectomy System
Developed in‑house by FuseMedTech, the FuseVive® system features a minimally‑invasive “large‑bore aspiration + mechanical thrombectomy” workflow for safe, efficient removal of large thrombus within the main pulmonary artery and its major branches. Key clinical benefits:
– Robust Thrombus Clearance: Proprietary dual‑set disc geometry conforms to native pulmonary artery anatomy and improves mural thrombus removal efficacy.
– Intra‑procedural Bleeding Control: Adaptive hemostasis valve minimizes unnecessary blood loss and enhances patient safety.
– High‑Performance Aspiration: Volume‑calibrated aspirator pairs with the large‑bore aspiration catheter to deliver consistent high negative pressure. It reduces catheter clogging and shortens procedure duration.
– Simplified Workflow: Streamlined device design supports intuitive handling, improves operating efficiency and flattens the operator learning curve.
Kossel Medtech pursues its dual‑focus strategy of in‑house innovation and ecosystem integration, expanding its pan‑vascular interventional footprint through strategic acquisitions and industry partnerships.
Through in‑house strategic acquisitions, Kossel Medtech has integrated Biotriton Medical and Xinzhi Medical. Biotriton brings peripheral intravascular ultrasound (IVUS) technology, completing the full care pathway of “imaging assessment → targeted intervention”. Xinzhi Medical develops drug‑coated balloons with both sirolimus‑ and paclitaxel‑based formulations, strengthening Kossel Medtech’s market position for “implant‑free coronary intervention”.
For external alliances, Kossel Medtech has signed strategic agreements with Innomed and Silvan Medical, securing exclusive overseas distribution rights for the Python peripheral drug‑coated balloon (DCB) and Clothoid vascular closure device, accelerating global market access for China‑origin innovations. Kossel Medtech’s platform capabilities are globally recognized, with deep‑running joint projects alongside industry leaders Abbott and Medtronic covering R&D, clinical development and commercialization, enabling mutual knowledge and resource exchange between domestic innovation and global healthcare stakeholders.
This collaboration marks a major milestone for Kossel Medtech’s ecosystem build‑out. It broadens the company’s peripheral intervention product portfolio and advances its vision of delivering a complete one‑stop peripheral interventional solution. As the partnership evolves, both parties will explore further joint innovation, bring diverse interventional treatment options to clinicians worldwide, benefit larger patient cohorts, and drive high‑quality sustainable progress within China’s peripheral intervention sector.
Exclusive overseas distribution plus technical cooperation advances Kossel’s peripheral DCB value chain roadmap
Suzhou, China — Kossel Medtech (Suzhou) Co., Ltd. (“Kossel”) has entered into a strategic cooperation agreement with InnoMed Technology Limited(“InnoMed”). Pursuant to the strategic cooperation agreement, Kossel is granted exclusive overseas distribution rights for InnoMed’s Python Drug-Eluting Dilatation Catheter. Drawing on its established commercial footprint spanning more than 20 countries, Kossel will drive global market adoption of the device. The partnership also includes technical collaboration: InnoMed will open its Python DCB patent platform to Kossel, laying the groundwork for the company’s future in‑house peripheral DCB development and bundling with complementary peripheral interventional consumables.
The technology and distribution partnership reflects an evolving go to market model for Chinese medical device exports. Rather than pursuing capital heavy, ground up overseas channel build out, domestic firms are now matching proven innovative products with mature global commercial infrastructure to speed international penetration through strategic synergy.
Powerful Alliance Expands Global Reach of “Implant Free Intervention”
Peripheral arterial disease (PAD) is a common, serious yet under‑recognized cardiovascular condition affecting over 200 million people worldwide, with rising prevalence. China faces a rapidly growing disease burden as well. According to the China Vascular Surgery Medical Device Industry Innovation and Development Report, an estimated 45 million Chinese patients lived with PAD in 2024, and that figure is projected to climb to roughly 62 million by 2030.
This large patient pool creates substantial unmet clinical needs. High restenosis rates remain a major limitation of standard plain balloon angioplasty. While stents address acute vessel elastic recoil, they carry long term risks including in stent restenosis and stent fracture. Clinicians have long sought therapies that restore vessel patency without leaving permanent implants inside the body.
Drug coated balloons (DCBs) fill this clinical gap. During balloon dilation, antiproliferative drugs are transferred to the vessel wall to suppress excessive smooth muscle cell proliferation, achieving revascularization while enabling implant free intervention. The 2025 Chinese Expert Consensus on Standardized Application of Lower Extremity Arterial Drug Coated Devices notes that DCBs and comparable drug coated devices effectively mitigate restenosis after lower limb endovascular procedures and are becoming a preferred treatment for peripheral arterial disease.
At the heart of the new collaboration is InnoMed’s Python Drug-Eluting Dilatation Catheter. Built on a platform engineered to match the performance benchmarks of leading international peripheral balloon catheters, it leverages proprietary coating technology for high drug coating stability. Its patented coat first then crimp manufacturing workflow delivers a low crossing profile of 1.28 mm. Upon balloon inflation, paclitaxel rapidly transfers to the vessel wall, delivering therapeutic drug doses while restoring vessel patency.
Kossel already has proven DCB commercial success in coronary interventions. In June 2026, the company acquired Xinzhi Medical, adding its sirolimus and paclitaxel coated balloon portfolio to its coronary pipeline. Combined with coronary scoring balloons and drug eluting stents from wholly owned subsidiary Mixin Medtech, Kossel now offers a full coronary solution suite covering pre treatment, implant free intervention and permanent stent implantation.
As clinical evidence for peripheral DCBs continues to accumulate, China’s volume based centralized procurement policies are reshaping domestic pricing and competitive dynamics. Expansion into high demand, higher margin international markets has become a key strategic priority.
As a pan vascular interventional platform enterprise, Kossel pursues its “Local Base, Global Reach” globalization strategy with end to end overseas capabilities spanning regulatory registration, distributor network management and global marketing. This partnership exemplifies how Chinese med‑tech firms leverage technical, product‑related and commercial‑channel strengths to build global market competitiveness, expanding the global footprint of implant‑free therapies and elevating the international visibility of Chinese peripheral interventional devices.
Eight Year CD TLR of 16.08 %: Python DCB addresses complex peripheral lesions
For implant free interventional devices, core design objectives center on reliable, safe delivery of antiproliferative agents to target lesions while sustaining therapeutic drug concentrations within vessel tissue. Python DCB achieves this via three key technical innovations.
Robust coating for efficient drug transfer: Using the patented coat first then crimp process, drug is applied to the fully expanded balloon before folding and crimping, supporting consistent, high quality drug loading. The balloon carries paclitaxel with iopromide as carrier, with a drug load of 3 μg/mm² and target vessel drug retention of ≥ 60 %. Upon dilation, drug rapidly transfers into vessel tissue to maintain therapeutic levels.
Excellent deliverability: Enabled by its coating technology, Python DCB features a minimal crossing profile down to 1.28 mm, compatible with 5 Fr sheaths, supporting smooth trackability and improved crossability through complex lesions.
Controlled dilation performance: Nominal pressure is 8 atm, rated burst pressure ranges from 14 atm to 16 atm, and recommended inflation time is at least 120 seconds. Operators have a broad safe operating window for dilation, mitigating risks of balloon rupture or insufficient drug transfer.
Compared with coronary anatomy, peripheral vasculature presents broader and more complex anatomies, with wide variability in vessel diameter, lesion length and calcification across segments. Femoropopliteal disease carries high prevalence with highly variable lesion morphology; long segment occlusions remain one of the most intractable challenges in peripheral intervention.
Python DCB comes in 47 available specifications, with diameters ranging 2.0 mm 7.0 mm and lengths 60 mm 200 mm. It is indicated for percutaneous transluminal angioplasty (PTA) of de novo lesions, restenotic lesions and in stent restenosis within the superficial femoral, popliteal and infra popliteal arteries. Its design specifications are backed by real world clinical validation, delivering value extending beyond isolated technical parameters.
The multicenter IN DEPT SFA trial was led by Professor Weiguo Fu (Zhongshan Hospital, Fudan University), with participation from top vascular surgery sites including Beijing Anzhen Hospital, Chinese PLA General Hospital and the Second Xiang ya Hospital. The study enrolled 160 patients, 54.9 % with total occlusions and a mean baseline stenosis of 94.3 %, representing a high risk, complex patient population beyond routine clinical presentations.
Published in the Journal of Vascular and Interventional Radiology (JVIR), study outcomes demonstrated an 84.4 % primary patency rate at 12 months, with a clinical driven target lesion revascularization (CD TLR) rate of only 3.1 %. Most patients avoided repeat revascularization within the first year. These outcomes reduce indirect costs associated with repeat procedures, additional device consumption and re admission, delivering meaningful health economic value amid cost control pressures in China.
Notably, eight year follow up data report a CD TLR rate of 16.08 %. The dataset supports durable long term vessel patency rather than only short term procedural success. Globally, “one procedure, long term clinical benefit” is a key value proposition for physicians, patients and payers — and forms the core rationale for Kossel’s global launch of Python DCB.
Peripheral intervention is a core strategic business pillar for Kossel. The company has built a comprehensive peripheral product portfolio including vena cava filters, peripheral thrombus aspiration systems, scoring balloons and peripheral IVUS catheters. Adding Python DCB strengthens Kossel’s market position in peripheral arterial disease treatment. Parallel technical cooperation will advance the company’s roadmap from third party global distribution toward in house iterative product development.
From Clinical Validation to Global‑Scale Commercial Rollout: A New Blueprint for Chinese Med‑Tech Global Expansion
Driven by aging populations, rising PAD prevalence and expanding adoption of minimally invasive procedures, the global peripheral interventional device market is growing rapidly. According to QY Research, the market reached RMB 76 billion in 2025 and is forecast to hit RMB 123.64 billion by 2032, corresponding to a 7.3 % compound annual growth rate.
According to Kossel, competition within China has grown increasingly intense. Centralized procurement and healthcare‑system payment reforms continue to compress pricing room, placing widespread dual pressures of commercial execution and sustained innovation on industry players. Medical‑device development is inherently collaborative consolidation‑oriented in nature, and China’s med‑tech sector is undergoing accelerated industry consolidation. Kossel operates manufacturing sites across Europe and Southeast Asia, with operational systems aligned with international standards. This collaboration aims to jointly deliver high‑quality, competitive China‑origin innovative medical devices and build Chinese brands with global influence.
For InnoMed, this collaboration represents the fastest, most scalable path for Python DCB’s global commercialization. China’s comprehensive manufacturing ecosystem and engineering talent form a strong competitive foundation for China‑origin med‑tech players. InnoMed contributes independent R&D capabilities, including in‑house development of core production equipment; Kossel brings mature global commercialization infrastructure. Their complementary strengths enable expanded global product pipelines and real‑world commercial deployment.
Over two decades of development, China’s pan‑vascular interventional sector has attracted numerous market participants, yet larger scale does not always equal stronger industrial capability. As international markets have become an indispensable strategic priority, how to deliver Chinese innovations through structured, high‑value global market expansion will define the next phase of industry landscape. This collaboration between Kossel and InnoMed establishes a replicable blueprint: lowering barriers to global market entry through precise alignment of products and channels, while securing long‑term building of core capabilities via technology transfer. This combined “product + channel + technology” integrated offering transforms overseas expansion from a solitary undertaking for individual enterprises into systematic value output from China’s med‑tech industrial chain.
References
VINNOVA 2026 | Guo Wei. China Vascular Surgery Medical Device Industry Innovation and Development Report. Clinic Vascular & Endovascular News
Chinese Expert Consensus on Standardized Application of Lower Limb Arterial Drug Coated Devices (2025 Edition). Chinese Journal of Practical Surgery
A New Drug Coated Balloon for the Treatment of Superficial Femoropopliteal Artery Disease: 12 Month Results from the IN DEPT SFA Trial. Journal of Vascular and Interventional Radiology (JVIR)
QY Research. 2026 Global Peripheral Vascular Intervention Device Market Size, Major Players, Domestic & Global Market Share and Ranking Report
Kossel is pleased to announce a major regulatory milestone. Its peripheral interventional device portfolio has obtained EU CE‑MDR certification, granting official European market access and marking a key step in the company’s global expansion.
All four newly‑certified devices are independently developed in‑house by Kossel: Falspeed® PTA Balloon Dilatation Catheter, Falexpand® HP PTA Balloon Dilatation Catheter, Tanghulu® PTA Peripheral Balloon Dilatation Catheter, and Giranel® Guiding Sheath Set. Together, they form a complete peripheral interventional product portfolio for overseas markets.
Alongside previously CE‑MDR‑approved coronary products including the Selethru® PTCA Balloon Dilatation Catheter and Seledora® Coronary Scoring Balloon Catheter, these offerings create dual‑track peripheral‑coronary pipelines. This fuels execution of Kossel’s global strategy and delivers one‑stop endovascular interventional solutions covering diverse clinical scenarios and lesion types.
Guided by its global strategy “Local Base, Global Reach”, Kossel has built manufacturing facilities in Europe and Southeast Asia, with branch offices in Japan and other regions. The company competes globally through strong product value, robust quality‑management systems and full regulatory compliance.
These latest CE‑MDR approvals further strengthen Kossel’s international brand footprint, enabling high‑quality Chinese‑manufactured medical devices to benefit more patients worldwide.
Held in São Paulo, Brazil from July 29 to 31, 2026, SOLACI & SBHCI 2026 stands as the flagship annual event for cardiovascular intervention across Latin America. The conference brought together leading global specialists in panvascular intervention, clinicians and industry distributors. Through academic forums, hands-on training sessions and product exhibitions, participants explored new pathways for advancing cardiovascular care in the region.
High-Profile Exhibition Unlocks New Opportunities in South America’s Cardiovascular Industry
Kossel made a strong presence with its full portfolio of interventional devices. Backed by a comprehensive product lineup and established international certifications, the company stepped onto the Latin American stage to forge deeper connections with local stakeholders and accelerate the execution of its global strategy.
Demand for cardiovascular care continues to rise across South America. Clinicians are increasingly seeking cost-effective, one-stop interventional device solutions covering full clinical workflows, making the region a promising destination for innovative Chinese medical device manufacturers expanding overseas. Kossel has designated South America as a key strategic pillar of its global layout. By participating in this exhibition, the company targeted local market needs and consolidated distribution channels across Brazil, Argentina, Colombia and other countries, building a stable, long-term platform for regional dialogue and collaboration.
Leveraging years of global R&D and registration efforts, multiple products covering coronary, peripheral and electrophysiology segments have obtained authoritative MDR CE certifications, granting complete market access qualifications and laying a solid compliance foundation for sustained development in South America.
Kossel’s all-inclusive panvascular interventional portfolio drew constant inquiries from professional visitors and earned widespread industry attention. On-site team members elaborated on the design merits, intraoperative performance and long-term cost-effectiveness of Kossel devices, addressing key clinical challenges prevalent in South America.
The exhibition strengthened overseas partners’ recognition of Kossel’s innovative devices while gathering valuable frontline clinical feedback. Such insights support targeted overseas product optimization and localized R&D improvements, creating mutual value for product iteration and regional market expansion.
Rooted in São Paulo, with a vision for broader South America and beyond, Kossel will continue delivering high-quality innovative panvascular interventional devices, deepen international partnerships across South America and worldwide, and bring advanced Chinese medical technology to benefit more patients and clinicians
From July 16 to 18, 2026, the 34th Annual Meeting of the Japanese Cardiovascular Intervention Therapeutics (CVIT 2026) was successfully held at Tokyo International Forum. The conference brought together top clinical specialists, researchers and leading industry players worldwide to discuss cutting-edge advances and future trends in minimally invasive interventional diagnosis and treatment.
With years of in-depth expertise in the vascular intervention sector, Kossel Medtech (Suzhou) Co., Ltd. showcased its flagship coronary products at the exhibition, fully demonstrating its technological heritage and innovative strengths in precise vascular interventional treatment. Driven by continuous technological innovation and rigorous quality control, Kossel’s PTCA balloon, NC PTCA balloon and inflation device have obtained PMDA approval in Japan. Established market channels are in place, and multiple products have been adopted for clinical use in numerous hospitals, earning solid market recognition.
Kossel’s booth drew steady crowds throughout the event. The team conducted in-depth market engagement targeting Japan and hosted dedicated discussions with more than 20 Japanese clinicians. Exchanges centered on practical clinical operation details of interventional devices, directions for technological upgrades and Japanese market access requirements, alongside pragmatic discussions on regional promotion strategies. These conversations accurately captured the unique clinical demands of the Japanese market, laying a solid foundation for subsequent product registration, clinical adoption and customized R&D in Japan.
Kossel’s journey at CVIT 2026 has concluded successfully. Moving forward, Kossel Medtech will continue to expand its footprint in Japan, accelerate overseas certification of new products, enrich and optimize its product portfolio, and empower global clinical practice with high-quality vascular interventional medical devices and professional services.
Recently, Selethru® PTCA Balloon Dilatation Catheter, independently developed by Kossel Medtech, has obtained official marketing approval from Singapore’s Health Sciences Authority (HSA). This milestone further optimizes the Company’s strategic layout across Southeast Asia and accelerates its global expansion drive.
As a hub for medical innovation in Southeast Asia, Singapore boasts world-leading medical regulatory frameworks and stringent market access criteria. The approval stands as high recognition by HSA of Selethru® PTCA Balloon Dilatation Catheter in terms of its safety, clinical efficacy and quality control system. It also diversifies the range of coronary interventional devices available in Singapore and the broader Southeast Asian region, bringing clinical benefits to local patients.
To date, Selethru® PTCA Balloon Dilatation Catheter has achieved large-scale commercialization across Asia, the Middle East, South America and North America. It has obtained multiple authoritative international certifications, including EU MDR, US FDA clearance, South Korea KFDA approval and India CDSCO certification, with its presence covering major medical device markets worldwide.
The successful Singapore registration marks another vital breakthrough in Kossel Metech globalization strategy. Moving forward, the Company will continue to deepen its expertise in panvascular intervention, uphold technological innovation and rigorous quality refinement, and steadily advance its global market deployment. We aim to bring domestically developed innovative medical devices to the world, deliver care to patients globally, and contribute Chinese expertise to the diagnosis and treatment of panvascular diseases worldwide.
Recently, Selethru® PTCA Balloon Dilatation Catheter, independently developed by Kossel Medtech, has obtained official marketing approval from Singapore’s Health Sciences Authority (HSA). This milestone further optimizes the Company’s strategic layout across Southeast Asia and accelerates its global expansion drive.
As a hub for medical innovation in Southeast Asia, Singapore boasts world-leading medical regulatory frameworks and stringent market access criteria. The approval stands as high recognition by HSA of Selethru® PTCA Balloon Dilatation Catheter in terms of its safety, clinical efficacy and quality control system. It also diversifies the range of coronary interventional devices available in Singapore and the broader Southeast Asian region, bringing clinical benefits to local patients.
To date, Selethru® PTCA Balloon Dilatation Catheter has achieved large-scale commercialization across Asia, the Middle East, South America and North America. It has obtained multiple authoritative international certifications, including EU MDR, US FDA clearance, South Korea KFDA approval and India CDSCO certification, with its presence covering major medical device markets worldwide.
The successful Singapore registration marks another vital breakthrough in Kossel Metech globalization strategy. Moving forward, the Company will continue to deepen its expertise in panvascular intervention, uphold technological innovation and rigorous quality refinement, and steadily advance its global market deployment. We aim to bring domestically developed innovative medical devices to the world, deliver care to patients globally, and contribute Chinese expertise to the diagnosis and treatment of panvascular diseases worldwide.
Recently, Falspeed® PTA Balloon Dilatation Catheter and Falexpand® HP PTA Balloon Dilatation Catheter, two independently developed products by Kossel Medtech, have officially secured registration certification from the Department of Health of the Hong Kong Special Administrative Region (HKSAR), granting approval for marketing and sales in Hong Kong.
As an Asian hub for medical innovation and a key platform for international medical technology exchange, Hong Kong SAR operates the MDACS registration framework renowned for stringent international standards. Specifically, Class III medical devices are subject to rigorous audits covering safety, clinical efficacy and quality management systems prior to registration.
Previously, Falspeed® PTA Balloon Dilatation Catheter and Falexpand® HP PTA Balloon Dilatation Catheter have successively obtained approvals including the U.S. FDA clearance and Brazil’s ANVISA certification. The latest Hong Kong SAR registration represents another landmark milestone in the Company’s internationalization strategy. It expands Kossel Medtech’s portfolio of peripheral interventional devices to cover core Asia-Pacific markets, delivering a diversified range of treatment options for clinicians in Hong Kong SAR.
Leveraging the geographic and policy strengths of the Guangdong-Hong Kong-Macao Greater Bay Area in the years ahead, Kossel Medtech will further deepen collaboration with medical institutions across Hong Kong SAR. The Company aims to elevate regional diagnosis and treatment standards for peripheral vascular diseases, advance the implementation of the Healthy China Initiative, and strengthen integrated cooperation and service capabilities under the Belt and Road Initiative for healthcare collaboration.
Previously, Kossel Medtech (Suzhou) Co., Ltd. (hereinafter referred to as “Kossel Medtech”) completed the strategic acquisition of the peripheral vascular intervention business of Shanghai Biotriton Medical Technology Co., Ltd (hereinafter referred to as “Biotriton Medical”), further strengthening Kossel Medtech’s comprehensive one-stop diagnosis and treatment portfolio in the peripheral intervention field.
Recently, Biotriton Medical’s independently developed K-VisionMax™ Peripheral IVUS System, including the Peripheral Intravascular Ultrasound Diagnostic Catheter (Registration No.: GXZZ 20263061165) and the Intravascular Ultrasound Diagnostic System (Registration No.: GXZZ 20263061218), has successfully received market approval from the National Medical Products Administration (NMPA).
K-VisionMax™ Peripheral IVUS System
Four Key Advantages
30 MHz High-Definition Imaging
Equipped with a 30 MHz mechanically rotating transducer, delivering clearer images and richer anatomical details.
40 mm Ultra-Wide Imaging Range
Featuring an extra-large 40 mm imaging diameter, enabling comprehensive visualization of both arteries and veins while meeting the demands of complex clinical cases.
0.018″ Rapid-Exchange Design
Compatible with standard 0.018″ guidewires and 6F introducer sheaths, allowing for easier operation and minimizing procedural trauma.
Comprehensive Clinical Application
Designed to support a full spectrum of peripheral vascular interventions, including the carotid arteries, lower-extremity arteries and veins, iliac veins, and other peripheral vascular applications.
As an important milestone in China’s peripheral vascular intervention sector, the K-VisionMax™ Peripheral IVUS System integrates high-definition imaging, procedural convenience, and broad clinical applicability into a single platform. It provides clinicians with a cost-effective and precise intravascular imaging solution, ushering in a new era of precision diagnosis and treatment in peripheral vascular intervention and benefiting more patients.
