MicroPort Melody™ Completes Full Enrollment in Pivotal Clinical Trial for Coronary Spiked Balloon

Sep 27, 2023 00:01 CST Updated 00:01

MicroPort

Innovative High-End Medical Device Group

MicroPort

High-end Medical Device R&D and Manufacturer

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

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Heart Future

Recently, Shanghai MicroPort Medical (Group) Co., Ltd. (referred to as "MicroPort® Coronary"), a subsidiary of MicroPort Scientific Corporation, announced that its subsidiaryShanghai MicroPort Melody Medical Technology Co., Ltd.(Abbreviation: MicroPort Melody™) has completed the enrollment of all subjects in the pre-market clinical study of the coronary artery cutting balloon (Abbreviation: CREST study).

The study was led by Professor Jun Bu from Renji Hospital, Shanghai Jiao Tong University School of Medicine, as the principal investigator, and Professor Xinkai Qu from Huadong Hospital, Fudan University, as the co-principal investigator. It was conducted across six hospitals, including Yuebei People's Hospital, Fengxian District Central Hospital of Shanghai, the Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, and Jing'an District Central Hospital of Shanghai.

# Introduction to Clinical Research

The CREST study is a prospective, multicenter, randomized controlled trial designed to evaluate the safety and efficacy of the Spur Balloon in treating coronary artery stenosis.

The study plans to enroll 200 subjects with primary coronary artery stenosis, allocated in a 1:1 ratio to the experimental group and the control group. The primary endpoint is immediate lumen gain, while secondary endpoints include effectiveness outcomes such as immediate device success, lesion success, procedural success, and safety outcomes such as postoperative death, myocardial infarction, and revascularization.

The study was initiated in January 2023 and successfully completed the enrollment of all subjects within 8 months.

The launch of the CREST study will promote the subsequent release of the coronary scoring balloon in China, with the potential to help more patients with coronary heart disease. MicroPort Melody™ will continue to focus on the research and development of high-end innovative medical devices through continuous technological innovation, further enriching the MicroPort® coronary cardiovascular intervention product line. This will provide patients with more high-quality and accessible comprehensive solutions for coronary heart disease, wholeheartedly safeguarding every patient with coronary heart disease.

# Product Introduction

The棘突球囊 is a novel balloon featuring three raised棘突棱 on its surface that form a wedge structure. When the balloon expands, it creates longitudinal "cutting" effects in three directions, helping to form plaque fissures and achieve better expansion results.

This design not only effectively reduces the slippage phenomenon during the expansion of ordinary pre-dilation balloons, but the stress concentration of the棘突棱in the longitudinal direction during balloon expansion can also alleviate circumferential pressure and reduce the risk of damaging the normal blood vessel wall.

▲ MicroPort Melody™ Coronary Scoring Balloon

Huadong Hospital Affiliated to Fudan University Participated in This TrialProfessor Qu Xinkai stated:"The棘突球囊of MicroPort Melody™ has demonstrated good safety and efficacy in treating coronary artery stenosis, effectively improving immediate lumen gain, thereby enhancing the prognosis of coronary artery stenosis, especially complex lesions such as calcification."

# Company Profile

Shanghai MicroPort Melody Medical Technology Co., Ltd. (referred to as: Shanghai Melody Medical) was established in 2020 as a member of MicroPort. It is a company mainly engaged in the promotion and application service industry of technology.Invested in 1 enterprise.

As of the date of this report, the company's financing history is as follows:

As of the date of this report, the following partial patent information of the company has been queried:

Overseas Cardiovascular Devices:

Products of Chinese Cardiovascular Companies: