Sino Medical's TRADENT™ Hai Shen Ji™ Coronary Scoring Balloon Catheter Receives NMPA Approval for Market Launch

Sep 21, 2023 06:50 CST Updated 00:00

Century Healthcare

Medical Device Manufacturer, R&D, and Distributor

Source of the article:Heart NotCome;Editor: Zhang Yuqing

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Heart Future

According to the information from the National Medical Products Administration,Sino Medical Science and Technology Co., Ltd. (Abbreviation: Sino Medical) Product: Coronary Artery Cutting Balloon Dilation Catheter Approved, Medical Device Registration Certificate Number: China Medical Device Registration Approval 20233031323.

# Product Introduction

This Obtains the "Medical Device Registration Certificate"Coronary Artery Spur Balloon Dilation Catheter (TRADENT™ Neptune Trident™), is a product independently developed by Sino Medical and falls under the category of cutting balloon products in China.The first approved product，The product is designed to balance the three core requirements of passability, cutting effect, and safety.

TRADENT™ Triton™ Spinous Balloon Dilation Catheter DesignThe Biggest HighlightIt adopts a "spiral" layout of nickel-titanium alloy棘突丝on the balloon surface, which gives the balloon strong embedding ability while maintaining good passability.

After the balloon is pressurized, it can effectively lock calcified plaques and perform 360° comprehensive plaque debulking, achieving controlled and efficient pre-treatment.

Due to the shape memory advantage of nickel-titanium alloy, after the balloon is depressurized, the tines can still retract to their original shape, making it easier and safer to withdraw the balloon from the coronary artery.

# Highlighted Advantages

Compared with the current parallel plaque-modifying balloons on the market, under the same specifications and model,"Spiral" DesignMore spur units can be arranged, with smaller side holes between the spur wires, allowing for more comprehensive coverage of the plaque.

Moreover, such a design can also achieve dispersed and small cracks under lower burst pressure, effectively reducing the incidence of delamination.

In terms of device passability, this product effectively reduces the introduction outer diameter and enhances its vascular compliance through processes such as a blunt-rounded TIP head design and U-shaped thermal fusion linking.

Compared with the only imported棘突球囊currently available in the Chinese market, it has received high praise in terms of clinical trial data and the operational experience of clinicians.

The approval of the company's TRADENT™ Triton™ Spinous Balloon Dilation Catheter will effectively meet clinical needs, further increase the success rate of lesion dilation, reduce the risk of complications such as vascular perforation and damage to normal vascular walls during surgery, and provide doctors with more choices of clinical instruments.

# SinoMed

Sino Medical Science and Technology Co., Ltd. (Abbreviation: Sino Medical, Stock Code: 688108) is a company rooted in China, oriented towards the global market, and specializing in the research, development, production, and sales of high-end interventional medical devices.

The company was founded in 2007 in the Tianjin Economic-Technological Development Area and has wholly-owned subsidiaries in Beijing, Suzhou, Hong Kong, the United States, Japan, the Netherlands, and France. In October 2019, the company was listed on the Shanghai Stock Exchange, becoming a STAR Market-listed enterprise.

After more than a decade of development, Sino Medical has establishedWith international standardsThe research and development, production, and operation system covers key areas of interventional treatment such as cardiovascular, cerebrovascular, and structural heart diseases.

Currently, the company owns more than 200 patents globally, covering major countries and regions including China, the United States, and Europe; it has undertaken 7 national and provincial scientific research projects, including key R&D program topics of the "13th Five-Year Plan" National Key Research and Development Program.

Since its establishment, the company's main products, including coronary drug-eluting stents, coronary balloons, intracranial rapid exchange balloons, and intracranial drug-eluting stents, have been used more than 1.4 million times, entering over 2,000 hospitals, benefiting hundreds of thousands of patients worldwide.

According to the company's 2022 annual report, the company achieved a total revenue of 193 million yuan, with the specific composition shown in the figure below:

Overseas Cardiovascular Devices:

Products of Chinese Cardiovascular Companies: