Category: Kossel

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.

Recently, MiStent® Sirolimus Eluting Absorbable Polymer Coronary Stent System, the flagship product of Mixin Medtech, a subsidiary of Kossel Group, has been successfully approved for market launch by the National Medical Products Administration (NMPA) (Registration Certificate No.: GXZZ 20263130833).

MiStent® Sirolimus Eluting Absorbable Polymer Coronary Stent System was developed following Kossel Group’s complete acquisition of Micell Tech. By integrating innovative technology with China’s Intelligent Manufacturing, it provides a new clinical option for Percutaneous Coronary Intervention (PCI) that features both rapid healing and long-lasting efficacy.

Dual-Excellence Design: Balancing Healing Efficiency and Long-Term Protection
Rapid Healing: Ultra-Thin Stent for Fast Endothelialization
The domestic MiStent® Sirolimus Eluting Absorbable Polymer Coronary Stent System is built on a 64 μm ultra-thin cobalt-chromium alloy platform, thereby minimizing vessel injury. Its absorbable drug coating eliminates drug burst release and does not inhibit early endothelialization, enabling faster healing.

Long-Lasting Efficacy: Controlled Sustained Release for Full Coverage
Crystalline sirolimus achieves an extra-long 9-month sustained release, persistently inhibiting intimal hyperplasia and vascular inflammation triggered during polymer elution and absorption.

As the core product of Mixin Medtech, the market approval of MiStent® Sirolimus Eluting Absorbable Polymer Coronary Stent System further completes the company’s product portfolio in the coronary intervention field. Moving forward, the company will continue to be clinical-needs oriented, accelerate the commercialization of more high-quality medical device achievements, inject strong impetus into vascular disease diagnosis and treatment, and support the construction of the **Healthy China** initiative.

Purpose-built for peripheral thrombus aspiration

How to address the issue that the angle between the inferior vena cava and the left iliac vein is large and there is a risk of tilting during the filter release？