PTA balloon catheter is mainly used for limb blood vessels, extended to the arteries, such as renal artery, coronary artery, and vein, such as the expansion of the vena cava stenosis, and treatment of artificial blood vessels, transplant vascular stenosis or occlusion.
1. A wide range of diameters and lengths are available, covering different clinical demands
2. The 3 wing or 6 wing folding techniques make the balloon’s profile small, raising passing capability for challenging stenosis
3. The soft and tapered tip helps the balloon get through lesions easily
4. The hydrophilic coating reduces friction during pushing process
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.
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.
