Industry news | Weichang ® "Intracranial Artery Drug-Coated Balloon Catheter" entered the special review process for innovative medical devices

National Health Commission Stroke Prevention and Control Engineering Committee official academic public account

On August 3, the Medical Device Technical Evaluation Center of the State Drug Administration announced the application result of the special review of innovative medical devices (No. 10 in 2021), and the Weichang ® intracranial artery drug-coated balloon catheter independently developed by Xinwei Medical was listed.

In 2018, the State Food and Drug Administration revised and issued the "Special Review Procedure for Innovative Medical Devices", which gives priority to innovative medical devices in accordance with the principle of "early intervention, special responsibility, and scientific review". It aims to promote the high-quality development of China's independent innovation medical device industry, help China's high-end medical device products to be listed as soon as possible on the basis of safety and effectiveness, and meet the needs of the people for medical health.

Weichang ®

Intracranial artery drug-coated balloon

Research and development background

intracranial atherosclerotic stenosis (ICAS) is one of the important causes of ischemic stroke, and there is a significant difference between different ethnic groups. The incidence of intracranial atherosclerotic stroke in the Asian population is 30%-50%.

Existing treatment options for ICAS

1. Drug treatment:

Antiplatelet drugs combined with risk factor control. When aspirin is used alone for symptomatic ICAS, 4 to 19 percent of patients still experience a recurrence of stroke each year.

Ii. Endovascular therapy

1. Balloon angioplasty (PTBA)

2. Balloon expansion stent implantation

3. Self-expanding stent implantation

Shortcomings of existing treatment options for ICAS

① Higher residual stenosis after bare balloon therapy alone;

(2) The limitations of stent treatment for the location of the lesion and the impact of permanent implantation of foreign bodies;

Weichang ®

Research and development of intracranial artery drug coated balloon

① It is expected to be better than drug therapy and naked balloon therapy;

② Intervention without implantation;

(3) Provide a new choice for the clinical treatment of ICAS;

Weichang ®

Intracranial artery drug-coated balloon

introduce

Working principle

① The drug-carrying balloon was transported to the intracranial vascular lesion through the interventional route, and the balloon was compressed and dilated to mechanically dilate the narrow part of the blood vessel;

(2) When the expanded balloon is in contact with the intima of the vascular wall, rapamycin carried on the balloon is rapidly released and diffused into the vascular wall tissue. At the same time of opening and restoring the vascular lumen, rapamycin transferred to the vascular wall can inhibit the hyperplasia of the vascular intima and prevent vascular restenosis.

Weichang ® features

Rapamycin drug coating

Rapamycin is a macrolide cell inhibitor, which does not cause cell apoptosis itself and does not cause inflammation to the intima of blood vessels. Less toxic and safer.

Innovative coating process

The patented coating process makes the drug coating stronger and the drug release rate better.

Thinner balloon walls are thicker

The smaller diameter of the folded balloon makes it easier to pass through the tortuous and narrow lesion site.

The effective length of the catheter is longer

The effective length of 160cm is better to reach the lesion site

RX Fast Exchange type

The clinical operation is more convenient

Weichang ®

Intracranial artery drug-coated balloon

Innovation & Leadership

First in China, leading in the world

• Search database: National Medical Products Administration website (Domestic & imported medical devices)

• Keywords: rapamycin/intracranial balloon/Intracranial/drug balloon/balloon catheter

• Search results summary: 0

• Search databases: US FDA website 510k database and PMA database

Search keywords: sirolimus, rapamycin, Balloon, intracranial, stenosis, catheter, ultrasonic

• Search results summary: 0

There are no clinical balloon products for the treatment of intracranial artery stenosis

Weichang ®

Intracranial artery drug-coated balloon

The future looks promising

The successful entry of XinweiMedical's rapamycin intracranial drug balloon into the "Innovative Medical Device Special Review Procedure" means that the safety of the "Weichang ® Intracranial artery drug coated balloon catheter" in clinical application and the effectiveness of the treatment of intracranial atherosclerotic stenosis. At the same time, the product will also provide a more effective way and choice for the treatment of intracranial atherosclerotic stenosis disease.

Xinwei Medical

HEART CARE

Shanghai Xinwei Medical Technology Co., LTD. (hereinafter referred to as: Founded in 2016, Xinwei Medical is a high-tech innovative medical company with independent intellectual property rights, focusing on the development and industrialization of minimally invasive intervention technology for stroke prevention and treatment. We have been practicing the concept of "brain and heart treatment, prevention and treatment of stroke" of the National Brain Prevention and Control Commission from the beginning, and are determined to become the world's leading stroke treatment and prevention overall solution company. Listen to the voice of patients, combined with the real needs of clinical, adhering to the "heart and brain health, creating heart and keeping Wei" of the original heart, and cardiovascular and cerebrovascular clinical experts for the global stroke patients to develop more to meet the clinical needs and more inclusive technology and products, to achieve Xinwei people "heart to protect life and health" mission and pursuit.

Based on innovative technology research and development, academic promotion and treatment popularization, Xinwei Medical has built a management team that combines production, learning and research, and a complete product line covering five categories of "ischemic stroke thrombolysis treatment, ischemic stroke stenosis treatment, hemorrhagic stroke treatment, cardiogenic stroke prevention and vascular access products".