Two Innovative Medical Devices — Cardiac Pulsed Field Ablation System and Proton Therapy System — Approved for Market in China
Jinjiang Electronic
Developer of electrophysiology products
On December 28, 2023, the NMPA announced two newly approved innovative medical devices. The original text is as follows:
# Disposable Cardiac Pulse Field Ablation Catheter and Cardiac Pulse Field Ablation Instrument Approved for Marketing
Recently, the National Medical Products Administration approvedSichuan Jinjiang Electronic Medical Device Science and Technology Co., Ltd.“Single-use Cardiac Pulse Field Ablation Catheter" and "Cardiac Pulsed Field Ablation System"Innovative Product Registration Application.
The disposable cardiac pulsed field ablation catheter consists of a catheter and a connecting cable. The cardiac pulsed field ablation system is composed of a main unit, an output box, and accessories.China's First Cardiac Pulse Field Ablation Product。
The above two products are used in conjunction to selectively cause irreversible electroporation damage to myocardial cells in the lesion area that requires treatment by controlling and releasing pulsed electric field energy of appropriate intensity, thereby achieving the purpose of treating atrial fibrillation. This provides more options for the treatment of drug-refractory, recurrent, symptomatic, paroxysmal atrial fibrillation.
The drug supervision and administration department will strengthen the post-marketing supervision of this product to protect the safety of patients using the device.
#Proton Therapy System Approved for Marketing
Recently, the National Medical Products Administration approvedVarian Medical Systems Particle Therapy Co., Ltd.“Proton Therapy System"Innovative Product Registration Application.
The product is composed of an accelerator subsystem and a treatment subsystem.China's first approved proton therapy system using a superconducting cyclotron and 360-degree rotating gantry, applicable for the treatment of systemic solid malignant tumors and benign conditions such as trigeminal neuralgia.
This product adopts superconducting cyclotron technology and utilizes a 360-degree rotating gantry to achieve multi-angle treatment; it has a fast startup speed, which can shorten patient treatment time while ensuring therapeutic efficacy, improving patient comfort.
The pharmaceutical supervision and administration department will strengthen the post-marketing supervision of this product to protect the safety of patients using the device.
Editor-in-Chief | Zhao Qing Reviewed by | Yi He
