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Intravascular Ultrasound Diagnostic Equipment and Disposable Intravascular Ultrasound Diagnostic Catheter approved for marketing

CCFDIE| Updated: 2023-04-28

Recently, the innovative products "Intravascular Ultrasound Diagnostic Equipment" of SonoScape Medical Corp. and "Disposable Intravascular Ultrasound Diagnostic Catheter" of Shanghai Acoustic Life Science Co., Ltd are approved for marketing by China NMPA. The two products are used together for ultrasonic imaging examination of coronary vascular diseases.

This combination product uses pulse echo technique to perform ultrasonic scanning and imaging of blood vessels. The device host and catheter controller send drive pulses to the ultrasonic transducer at the distal end of the catheter, and drive the transducer to rotate at a high speed through the driving shaft inside the sheath catheter. The transducer sends ultrasonic pulses and receives the ultrasonic echo signals reflected by the vascular tissue, which are amplified, collected and preprocessed by the catheter controller and transmitted to the device host to realize the display and processing of vascular images.

The disposable intravascular ultrasound diagnostic catheter is on the PMN-PT high frequency single crystal composite transducer, using the design and method of preparing glue free layer by evaporation with thickness ≤15μm. It realizes the localized manufacturing of high performance high frequency transducer, improves the image resolution and optimizes the image quality.

This combination product uses ultrasonic imaging with high frequency, wide bandwidth and high sensitivity, which can realize scanning, imaging and vessel diameter measurement of coronary vessels. It helps doctors to determine the severity and nature of the disease, further improve the understanding of coronary artery disease and guide interventional treatment.

The launch of this combination product is conducive to reducing the cost of clinical treatment, facilitating the clinical application and promotion of this technology, providing better diagnostic evidence for PCI precision diagnosis, and formulating better treatment strategies to benefit patients.

The NMPA will strengthen the post-marketing surveillance of the product to protect the safety of medical devices used by patients.