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Recently, after review, the State Medical Products Administration approved the registration application
for the innovative product "endovascular ultrasound diagnostic equipment" produced by Shenzhen Kaisheng Biomedical Technology Co.
, Ltd.
and the "disposable intravascular ultrasound diagnostic catheter" produced by Shanghai Aisheng Biomedical Technology Co.
, Ltd.
The two products are used together for ultrasound imaging of intravascular lesions in the coronary arteries
.
for the innovative product "endovascular ultrasound diagnostic equipment" produced by Shenzhen Kaisheng Biomedical Technology Co.
, Ltd.
and the "disposable intravascular ultrasound diagnostic catheter" produced by Shanghai Aisheng Biomedical Technology Co.
, Ltd.
The two products are used together for ultrasound imaging of intravascular lesions in the coronary arteries
.
This companion product uses the principle of pulse echo to image blood vessels with ultrasound scanning
.
The main machine of the equipment and the catheter controller send an excitation pulse to the ultrasonic transducer located at the far end of the catheter, and at the same time drive the transducer to rotate at high speed through the drive shaft inside the catheter sheath, and the transducer sends ultrasonic pulses and accepts the ultrasonic echo signal reflected by the vascular tissue, which is amplified, collected, and preprocessed by the catheter controller and transmitted to the host to realize the display and processing
of vascular images.
.
The main machine of the equipment and the catheter controller send an excitation pulse to the ultrasonic transducer located at the far end of the catheter, and at the same time drive the transducer to rotate at high speed through the drive shaft inside the catheter sheath, and the transducer sends ultrasonic pulses and accepts the ultrasonic echo signal reflected by the vascular tissue, which is amplified, collected, and preprocessed by the catheter controller and transmitted to the host to realize the display and processing
of vascular images.
The endovascular ultrasound diagnostic equipment adopts full digital signal transmission and single-array mechanical rotation design, and the digital transmission between the catheter controller and the imaging host is realized, which improves the integration and stability of the system while reducing the cost and making the image noise smaller
.
.
The process design and method of preparing a thickness of 15μm without glue layer and thickness ≤ on the PMN-PT high-frequency single-crystal composite composite transducer by single-vessel ultrasound catheter, realized the localization of high-performance high-frequency transducer production, improved image resolution and optimized image quality
.
.
This supporting product uses high-frequency, wide-bandwidth, high-sensitivity ultrasound imaging, which can realize coronary blood vessel scanning imaging and blood vessel diameter measurement, help doctors judge the severity and nature of lesions, help improve the understanding of coronary artery lesions and guide interventional treatment
.
.
The launch of this supporting product is conducive to reducing the cost of clinical treatment and the clinical application and promotion of this technology, providing a better diagnostic basis for PCI precision diagnosis and treatment, and formulating better treatment strategies to benefit patients
.
.
The drug administration department will strengthen the post-marketing supervision of the product to protect the safety of
patients.
patients.
