Category: Kossel

Recently, Kossel’s independently developed Selethru® PTCA balloon dilatation catheter has successfully passed the EU Medical Device Regulation (MDR) certification, marking that the product has met the highest international standards in terms of safety, effectiveness and clinical performance.

Europe is a globally important medical device market. The acquisition of MDR certification has provided strong support for Kossel to continue its in-depth expansion into Europe and its affiliated markets. In the future, the company will continue to advance the “Local Base, Global Reach” overseas strategy, strengthen cooperation with global medical institutions and experts, and enable more patients to benefit from Chinese medical devices!

Hospitalar 2025 | São Paulo, Brazil | May 20–23

Hospitalar, one of South America’s most influential healthcare exhibitions, concluded successfully in São Paulo. Leveraging Brazil’s strategic position in Latin America, the event has become a key platform for regional medical integration and international collaboration.

At this major event, Kossel Medtech showcased a portfolio of flagship products and localized solutions—highlighting our latest innovations in vascular intervention to a global audience.

Brazil, home to Latin America’s largest healthcare market, is a core part of Kossel’s strategic expansion. Our Falspeed® Peripheral PTA Balloon Catheter and Falexpand® High-Pressure Peripheral Balloon Catheter have already been certified by ANVISA, laying a strong foundation for local growth.

During the exhibition, Kossel Medtech welcomed partners and distributors from Brazil, Argentina, Mexico, Colombia, Peru, Chile, South Korea, and Ecuador. Our high-performance products and globally trusted solutions drew widespread interest, further solidifying our presence and reputation across Latin America.

Looking ahead, Kossel Medtech will continue to advance innovation in vascular intervention, accelerate our global market strategy, and deliver high-quality, application-driven solutions to healthcare professionals worldwide.

Innovation Without Borders. Reach Without Limits.

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一、Stent Design

The biodegradable coating (PLGA polymer combined with sirolimus crystals) was realized based on supercritical fluid technology, which gave birth to the Mistent® coronary drug-eluting stent. It has two distinctive features: “Quick Healing” and “Long-lasting Drug Efficacy”. The biodegradable polymer enables rapid endothelialization and reduces chronic inflammation and the occurrence of stent thrombosis; the controlled and slow-release of sirolimus drug crystals for up to 9 months reduces late lumen loss of the stent.

二、Clinical Study

Mistent® coronary drug-eluting stent system has undergone numerous clinical studies worldwide, involving over 2,000 patients.

DESSOLVE I

The DESSOLVE I study is a multicenter, single-arm clinical trial involving 30 patients. It assesses the device’s performance through coronary angiography, optical coherence tomography (OCT), and intravascular ultrasound (IVUS) and evaluates its safety through major adverse cardiac events (MACE) after MiStent SES implantation.
At different time points, late lumen loss (LLL) was measured by angiography. The results indicated that during the period of 6 months and 18 months, there was no progression of late lumen loss after implantation in these patients (0.9 ± 0.11 and 0.09 ± 0.15 respectively).

In the OCT analysis of results of the 4th, 6th and 8th months, thin and uniform vascular endothelial coverage was observed at the stent strut sites. The stent strut coverage occurred earlier and had a high coverage rate (93% at the 4th month, 97% at the 6th month, 96% at the 8th month, and 100% at the 18th month).

DESSOLVE II

DESSOLVE II is a randomized clinical trial that compared MiStent SES and Endeavor Sprint zotarolimus-eluting stents. A total of 184 subjects from 26 centers were randomly assigned in a 2:1 ratio to receive MiStent SES or Endeavor ZES implantation.
The results showed that MiStent SES was superior to Endeavor ZES, with a significant reduction in late lumen loss (0.27 ± 0.46 and 0.58 ± 0.41, p < 0.001).

In the subgroup analysis, patients underwent OCT and endothelial function analysis at the 9th month. The OCT analysis indicated that the proportion of endothelial coverage within the stent struts was high (99.7%), and there were no signs of poor stent strut adherence (0%). The endothelial function test showed that endothelial function was preserved. These results indicated that the vascular healing was good and the endothelial function returned to normal.
At 5 years after the operation, the incidences of major adverse cardiovascular events (MACE) in the MiStent group and the Endeavor control group were 15.1% and 22.0% respectively, and the incidence of target lesion revascularization (TLR) was 3.4% in both groups.

DESSOLVE III

DESSOLVE III study is a prospective, randomized, 1:1 controlled, single-blind, multicenter study that compared the clinical outcomes of MiStent SES and XIENCE in the “real-world all-comer” patient population at the 12th month.

This study demonstrated that MiStent SES was non-inferior to Xience, and that the TLF, TLR, ST and TVMI of MiStent SES showed a decreasing trend.

We had a fantastic time at PAIRS 2025, held from April 9–12 at the Dubai World Trade Centre!

As a company committed to innovation in vascular intervention, Kossel proudly showcased our flagship products from three key product lines: Peripheral Intervention, Coronary Intervention, and Cardiac Electrophysiology. It was a great opportunity to demonstrate our R&D strength and global vision in front of a truly international audience.

PAIRS, established in 2006, is the largest interventional radiology conference in the Arab region. We connected with doctors and partners from Saudi Arabia, Iraq, Turkey, Egypt, the UAE, Kuwait, Russia, South Africa, Mauritius, and more during the event. These conversations opened up new doors for collaboration and strengthened existing relationships.

Our coronary and peripheral balloon products are already being used in several countries across the region, and we’re honored to see them gaining real clinical recognition. With innovation at our core, Kossel is committed to listening to global needs, pushing forward with R&D, and delivering high-quality solutions worldwide.
This marks another important step in our strategy to expand across the Middle East, North Africa, and neighboring regions. Looking ahead, we remain rooted in China while growing globally—committed to delivering high-quality, innovative interventional solutions to doctors and patients around the world.