Source: Siyu MedTech; Editor: Qi Yuan
Reprint requirements: Can be reprinted 24 hours after the first publication, source must be credited.
On July 8, 2024, information released on the official website of the National Medical Products Administration showed,ApprovedArtechmed"Cryoblation Instrument", Farapulse, Inc."Single-Use Cardiac Pulsed Field Ablation Catheter" and "Cardiac Pulsed Field Ablation System"Three innovative product registration applications.
Cryoablation System
This product consists of a main unit, gas extension tube, and balloon catheter tail line, and is used in conjunction with a specific balloon-type cryoablation catheter.For the treatment of drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation in adult patients。Compared with similar products produced in China and abroad that have been marketed in our country, the "adjustable cooling capacity" and "rewarming reminder" technologies used in this product are pioneering.“Cold Quantity AvailableAdjustThe technology can monitor the freezing temperature in real time, reducing damage to adjacent tissues while ensuring the effectiveness of cryoablation treatment.。“Rewarming Reminder"Technology can reduce the risk of myocardial injury in patients caused by premature balloon retraction and the difficulty of balloon sheathing, as well as other clinical and operational risks."。Single-use Cardiac Pulse Electric Field Ablation Catheter, Cardiac Pulse Electric Field Ablation System
Single-use Cardiac Pulsed Field Ablation CatheterTubeComposed of a cardiac pulsed field ablation catheter and catheter connection cable.，Cardiac Pulsed Field Ablation SystemComposed of a pulsed electric field ablation device, recording module, and accessory cables.The above two products are used in combination for the treatment of patients with drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation. This product utilizes the non-thermal effects of pulsed electric fields for atrial fibrillation treatment, enabling selective destruction of myocardial tissue while avoiding the risk of surrounding tissue damage caused by heat transfer.。In recent years, the National Medical Products Administration (NMPA) has continued to promote the innovative development of the medical device industry. For innovative medical devices, on the basis of ensuring product safety, efficacy, and quality control, the NMPA follows the principle of maintaining standards and full procedures while assigning dedicated personnel for guidance throughout the process, giving priority to review, and accelerating product market entry.
As of now,277 Innovative Medical Devices Have Been Approved for Marketing，Among them, 27 have been approved since 2024, involving a variety of high-end medical devices such as bronchial navigation operation control systems, fundus lesion auxiliary diagnosis software for fundus images, extracorporeal ventricular assist devices, and renal artery radiofrequency ablation instruments, covering multiple fields including surgical robots, artificial intelligence medical devices, and cardiopulmonary support assistance systems.
The launch of these innovative products provides patients with more treatment options, effectively enhances surgical safety and success rates, reduces treatment costs, and better meets the needs of the public for high-end medical devices.
In terms of product types,The innovative medical devices approved in 2024 include 5 passive medical devices, 2 in vitro diagnostic reagents, and 20 active medical devices, covering 10 medical device classification directories. Among them, the number of active surgical devices and active implantable devices is relatively high. There are 17 medical devices produced in China, mainly distributed in Beijing, Shanghai, Jiangsu, Zhejiang, and Guangdong; and 10 imported medical devices.。
Next, the National Medical Products Administration will adapt to the needs of technological progress and industrial development, focus on key areas, research and introduce more specific supportive and encouraging measures, comprehensively promote the innovative and high-quality development of the medical device industry, and effectively maintain a high level of medical device safety.
# Atrial Fibrillation Treatment
Atrial fibrillation is a serious heart disease that poses a significant threat to human health. Compared with non-atrial fibrillation patients,Patients with atrial fibrillation have higher mortality rates, readmission rates, and stroke incidence, along with a general decline in quality of life.。With the continuous advancement of medical technology, patients with atrial fibrillation have more treatment options. Among them,Catheter ablation becomes the current maintenance for atrial fibrillation patientsSinus RhythmThe Main Treatment Methods, and pulmonary vein isolation (PVI) is the cornerstone of catheter ablation treatment.However, despite years of clinical exploration of various ablation energy sources including radiofrequency and cryoablation,But the development of these energy sources seems to have hit a bottleneck.。The high recurrence rate of ablation, the significant impact of the operator's experience on surgical outcomes, and the high incidence of ablation-related complications have always been obstacles that these energy sources have struggled to overcome.Therefore, there is an urgent need for a new type of catheter ablation technology that is safer, easier to operate, and more efficient to address these issues.Pulse ablation technology uses high-voltage pulsed electric fields to produce specific effects within the heart chambers.When an electric field is applied to tissue cells, the phospholipid bilayer in the cell membrane will shift and rearrange according to the direction of the electric field, a process that will causeIrreversible Electroporation of Cell MembranePhenomenon.This electroporation will trigger the apoptosis mechanism,Thereby effectively eliminating and blocking the transmission of abnormal potentials, becoming the next generation of disruptive ablation technology.
Artechmed was founded in 2017, with its headquarters located in the International Medical Park of Zhangjiang Science City, Shanghai, focusing on innovative solutions for cardiac electrophysiology diagnosis and treatment. The company has dual product technology platforms in Cryoballoon Ablation (CBA) and Pulsed Field Ablation (PFA), along with dozens of core independent intellectual property rights. The key team members all have extensive work experience in well-known medical device companies and possess rich expertise in the research and development, production, clinical development, commercialization, and company operations of products in the fields of electrophysiological diagnosis and treatment, cardiovascular and cerebrovascular interventions, cryoablation, and active medical devices.
Editor-in-Chief | Zhao Qing Reviewed by | Yi He
