On March 14, 2025, Seledora® Coronary Scoring Balloon Catheter, developed by Mixin Medtech(Suzhou) Co., Ltd., a subsidiary of Kossel Medtech (Suzhou) Co., Ltd., received approval from the National Medical Products Administration (NMPA) for market launch (Registration No. 20253030586). Kossel’s independently developed Octoparms® II Vena Cava Filter has also been approved by the NMPA today (Registration No. 20253130576).
The approval of the Seledora® Coronary Scoring Balloon Catheter marks another breakthrough for Kossel in the full-cycle management of “precise pre-treatment – vascular function restoration” in coronary interventions. Moving forward, Kossel will continue to drive innovation, providing high-quality medical devices to clinical practitioners and developing systematic solutions for coronary interventions.
On March 14, 2025, the Octoparms® II vena cava filter independently developed by Kossel Medtech (Suzhou) Co., Ltd. was approved by the National Drug Administration (NMPA). (registration number is 20253130576). In addition, the Seledora® coronary scoring balloon catheter developed by the subsidiary Mixin Medtech was also approved by the National Medical Products Administration (NMPA) today. (registration number is 20253030586).
Vena Cava Filter
Three core advantages upgraded
The stability upgraded
Retrieval hook is smooth to reduce delivery resistance
Raise and widen the balance arm to improve long-term stability
New anchoring hook design, anti-displacement, anti-penetration
Diamond-shaped filter can effectively block thrombus of 4mm and above
Releasable and interlocking arm design, to achieve controlled release in a transjugular way
Double markers with a space of 30mm, help measure the diameter of the inferior vena cava
The sheath is braided to enhance support and bending resistance and establish a stable path
The sheath end is thread design, anti-shift, easy to approach
The delivery system
Octoparms® vena cava filter, clinically proven, is a domestic umbrella-shaped filter with excellent performance, it has been recognized by nearly 2,000 hospitals in China since its launch, benefiting tens of thousands of patients.
Coming out of the clinic need and serving the clinic need, Octoparms® Ⅱ, an upgrade of the Octoparms® vena cava filter, will be more widely used and accepted for the benefit of more patients
The MiStent coronary drug-eluting stent, an important overseas transformation project of Corecell Medical, has officially entered the Chinese market with two major advantages of “rapid healing and long-lasting efficacy”, providing a new clinical option for PCI surgeries.
This issue will introduce the design story behind the realization of the “long-lasting efficacy” function of the MiStent coronary drug-eluting stent.
1. Encapsulated Sirolimus Crystals
The coating of the MiStent coronary drug-eluting stent is composed of a rapidly bioabsorbable PLGA polymer and sirolimus crystals embedded therein. Sirolimus crystals refer to the close arrangement of individual drug molecules to form a lattice structure, as shown in the figure:
Sirolimus molecules are compressed into a lattice structure
2. Polymer Degradation and Drug Crystal Release
When the PLGA polymer degrades, it softens and detaches from the metal stent platform. Over time, the polymer coating increasingly integrates into the surrounding tissues. The crystalline sirolimus embedded in the polymer also enters the surrounding tissues with it. The PLGA polymer of the MiStent coronary drug-eluting stent completely detaches from the stent within 45 – 60 days and is completely absorbed within 90 days.
Sirolimus crystals are embedded in the surrounding tissues
3. Dissolution of Drug Crystals and Release of Individual Drug Molecules
For individual sirolimus molecules to interact with receptors in arterial tissues, they must first dissociate from the lattice, then diffuse into the intercellular spaces of tissues, and finally pass through the cell membrane to reach the target cells. This process achieves a slow and continuous drug elution effect, and the efficacy can be maintained for up to 9 months, fully covering the coating degradation time, continuously inhibiting the excessive proliferation of vascular smooth muscle, and minimizing the incidence of in-stent restenosis.
MiStent® Sirolimus Eluting Absorbable Polymer Coronary Stent System’s ability to simultaneously offer the advantages of “rapid healing and long-lasting drug efficacy” is attributed to its unique coating process—supercritical fluid coating technology.
Mistent® coronary drug-eluting stent system, as an important overseas transformation project of Kossel Medical, has officially launched in the Chinese market with two advantages of “fast healing and long efficacy”, providing a new clinical choice for PCI surgery.
This article brings you the design story behind the realization of the “fast healing” function of Mistent®
一、Thin-wall stent design
Thick-wall stent can lead to stent thrombosis: high endothelial shear stress (ESS) at the top of the strut activates platelets; In the lower ESS area downstream of the strut, blood vortex is formed, which increases the concentration of locally activated platelets, delays re-endothelialization, and weakens the production of autogenous anticoagulants
After implantation of thin-wall stents into blood vessels, the physiological ESS was retained, which was conducive to platelet immobilization at the top of the strut, and promoted re-endothelialization and antithrombotic factor production downstream of the strut.
Mistent® uses a 64μm ultra-thin cobalt-chromium stent platform to achieve rapid endothelialization and reduce the risk of acute thrombosis.
Ordinate: stent strut thickness μm
二、Absorbable polymer coating
The coating of the Mistent® consists of a rapidly bioabsorbable PLGA polymer and embedded Sirolimus crystals
Under the dual action of polymer embedding and drug crystal binding, Mistent® implantation in blood vessels did not cause drug sudden release at the initial stage and did not delay vascular endothelialization
Endothelialization was achieved after 3 days of stent implantation
Endothelium was uniformly covered after 30 days of stent implantation
