Five Innovative Medical Devices Approved in China This Week, Including Proton Therapy System for Solid Tumor Treatment

　　【Pharmaceutical Network Product InformationAccording to the website of the National Medical Products Administration, within this week (December 25-29), five innovative medical device products have been approved for marketing. Among them, four are domestically produced innovative products: "Proton Therapy System" by Varian Medical Systems Particle Therapy Co., Ltd., "Disposable Cardiac Pulse Electric Field Ablation Catheter" and "Cardiac Pulse Electric Field Ablation Instrument" by Sichuan Jinjiang Electronic Medical Device Science and Technology Co., Ltd., and "Disposable Circular Pulmonary Artery Radiofrequency Ablation Catheter" by Wuxi Pulnovo Medical Technology Co., Ltd.; one imported product is "Human Breast Cancer Molecular Subtyping Detection Kit (PCR-Fluorescent Probe Method)" by BioNTech Diagnostics GmbH.
 

Data shows that the "Proton Therapy System" from Varian Medical Systems Particle Therapy Co., Ltd. utilizes superconducting cyclotron technology and can achieve multi-angle treatment through a 360-degree rotating gantry. It features fast startup speed, which can shorten patient treatment time while ensuring therapeutic efficacy, improving patient comfort. Reportedly, this product consists of an accelerator subsystem and a treatment subsystem. It is the first proton therapy system in China approved with a superconducting cyclotron and 360-degree rotating gantry, suitable for treating systemic solid malignant tumors and benign conditions such as trigeminal neuralgia.
 

Sichuan Jinjiang Electronic Science and Technology Co., Ltd.'s disposable cardiac pulse electric field ablation catheter consists of a catheter and a connecting cable. The cardiac pulse electric field ablation instrument consists of a main unit, an output box, and accessories. This is the first cardiac pulse electric field ablation product in China. These two products are used together to control and release appropriate intensity of pulsed electric field energy, selectively causing irreversible electroporation damage to myocardial cells at the lesion site that requires treatment, thereby achieving the purpose of treating atrial fibrillation. It provides more options for the treatment of drug-refractory, recurrent, symptomatic, and paroxysmal atrial fibrillation.
 

Pulnovo Medical Limited's "Disposable Circular Pulmonary Artery Radiofrequency Ablation Catheter" uses a puncture interventional approach to enter the body through the bloodstream. It works in conjunction with the company’s produced Pulmonary Artery Radiofrequency Ablation Instrument, delivering radiofrequency energy to act on corresponding targets in the pulmonary artery, thereby destroying sympathetic nerves and achieving the effect of treating pulmonary hypertension. This product is suitable for the adjuvant treatment of adult patients with drug-resistant idiopathic pulmonary hypertension, congenital heart disease-related pulmonary hypertension, and connective tissue disease-related pulmonary hypertension who are under 70 years old. Reportedly, the product consists of a radiofrequency segment, connection segment, bendable segment, main sheath, color marker, control handle, and connector. It is a product approved by China for treating pulmonary hypertension by destroying sympathetic nerves, providing a new treatment option for patients with pulmonary hypertension and benefiting more patients with pulmonary hypertension.
 

BioNTech Diagnostics GmbH "Human Breast Cancer Molecular Subtyping Detection Kit (PCR-Fluorescence Probe Method)" consists of a detection system mix, enzyme mix, positive control, and negative control. It is used for the in vitro semi-quantitative detection of mRNA expression levels of the genes ERBB2 (HER2), ESR1 (ER), PGR (PR), and MKI67 (Ki-67) in invasive breast cancer FFPE tissue slice samples. The product performs quantitative detection of mRNA expression levels of four target genes (ERBB2, ESR1, PGR, and MKI67) and two reference genes through reverse transcription real-time quantitative PCR (RT-qPCR) using Taqman technology. It provides further testing for cases where traditional immunohistochemical analysis is difficult to determine or where there is a significant discrepancy between traditional immunohistochemical analysis results and treatment expectations, assisting in determining breast cancer molecular subtypes, improving subtyping accuracy, and thereby helping doctors formulate more reasonable diagnosis and treatment plans.
 

According to the review, in December, the National Medical Products Administration approved a total of 9 innovative medical device products for marketing. In addition to the above-mentioned products, "Biodegradable Magnesium Metal Ligation Clips" by Suzhou Aoruiji Medical Technology Co., Ltd., "Pelvic Fracture Reduction Surgical Navigation and Positioning System" by Beijing Rosenbort Technology Co., Ltd., "Cryotherapy Device" and "Balloon Cryoablation Catheter" produced by Kangfeng Biotechnology (Shanghai) Co., Ltd. were also approved for marketing in December.
 

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