Yinyi®Drug-loaded coronary stent system without polymer micro-blind holes


Product Description

Yinyi® polymer-free microblind drug-loaded (paclitaxel) coronary stent (hereinafter referred to as "Yinyi® stent")
is a new generation of drug stent independently developed and produced by Yinyi Biotechnology.
The innovative drug delivery concept provides a safe, effective and economical treatment plan for patients with coronary artery stenosis.

 

Features

Traditional drug stents use high-molecular polymer carriers to carry drugs. With their widespread clinical use, many problems have been exposed, mainly as follows

Late stent thrombosis caused by delayed endothelial healing
Late stage catch-up of restenosis caused by polymer chronic irritation and inflammation
Acquired late adhesion
Therefore, patients need to take long-term anticoagulant drugs to cause more bleeding risk

The current effective means to solve these problems is to develop a new generation of polymer-free drug stents.

The Yinyi® stent adopts an innovative drug loading concept, and uses a special treatment process to construct
micro-scale blind holes to load paclitaxel on the metal surface, combining with the highly fat-soluble characteristics of paclitaxel.
To achieve the best combination of drug release and the effect of inhibiting cell proliferation.
Because there is no stimulating factor of high molecular polymer carrier, vascular endothelial cells are easier to cover the stent,
Realize healthy endothelialization and shorten the time for patients to take anticoagulant drugs.

Innovative microblind hole drug loading method
Patented technology realizes micro-blind hole polymer-free drug loading
The depth of the blind hole is less than 500nm, which is only 1/200 of the thickness of the stent
The pore diameter is 1~2μm, which is more than a thousand times larger than the paclitaxel molecule (<1nm)

Effective drug release
The microblind hole drug loading combined with the fat-soluble characteristics of paclitaxel,
the drug release and the effect of inhibiting cell proliferation achieve the best combination.

Green natural medicine
Paclitaxel, which is naturally extracted from the bark and branches of Taxus chinensis, is an internationally recognized first-line anti-tumor drug.
A large number of clinical applications have proved that the paclitaxel stent has more obvious therapeutic advantages than the rapamycin stent in the following aspects:
Suitable for vascular disease caused by coronary heart disease combined with diabetes
Suitable for the treatment of in-stent restenosis caused by rapamycin stent
Suitable for patients allergic to rapamycin

Higher cost performance
Yinyi® stent brings higher cost performance to patients, mainly reflected in:
It is an upgraded alternative product of polymer carrier drug stent
It has better curative effect than rapamycin stent in the treatment of coronary heart disease with diabetes
Patients do not need to take anticoagulant drugs for a long time, reducing the patient's postoperative drug expenditure

Clinical validation


The Yinyi® stent has been proven to be safe and effective after a number of large-scale clinical studies and extensive applications.
1 pre-marketing study (nearly 170 cases)
2 large clinical studies (1045 cases and 1626 cases respectively)
Implant use in 150,000 patients in 6 years
Widely used in more than 400 hospitals
It is currently the most used non-polymer coated drug stent in the world



 

Product Honor

In 2007, the product obtained the SFDA certificate, which is the first non-polymer-coated drug stent in China
In 2008, the product obtained the national authorized invention patent (ZL200610109422.8)
In 2008, the product was appraised as the four highlights of my country’s medical device research and development by the State Food and Drug Administration’s “China Medical News”, and is considered to be an internationally leading drug stent
In 2008, the product was introduced by the "Guangming Daily", "Technology Daily" and other large domestic media
In 2009, the product obtained the certificate of independent innovation product
In 2011, the product won the first prize of Dalian Technical Invention
In 2012, the microblind hole drug-loading patent won the Liaoning Provincial Patent Excellence Award

Product Specification

支架长度
(mm)
支架直径 (mm)
2.50 2.75 3.00 3.50 4.00
8 DSS2508 DSS2708 DSS3008 DSS3508 DSS4008
10 DSS2510 DSS2710 DSS3010 DSS3510 DSS4010
12 DSS2512 DSS2712 DSS3012 DSS3512 DSS4012
15 DSS2515 DSS2715 DSS3015 DSS3515 DSS4015
18 DSS2518 DSS2718 DSS3018 DSS3518 DSS4018
21 DSS2521 DSS2721 DSS3021 DSS3521 DSS4021
23 DSS2523 DSS2723 DSS3023 DSS3523 DSS4023
26 DSS2526 DSS2726 DSS3026 DSS3526 DSS4026
28 DSS2528 DSS2728 DSS3028 DSS3528 DSS4028


Registration Message

Medical device name: drug-coated coronary metal stent system (trade name: Yin Yi)
Medical device manufacturer name: Liaoning Yinyi Biotechnology Co., Ltd.
Registration certificate number: National Machinery and Approval 20163462300