China's First Domestically Developed ICD Receives NMPA Approval with Nearly Doubled Service Life

Recently, the PLATINIUM™ series of implantable cardioverter defibrillators (ICDs) manufactured by Microport Sorin Crm (Shanghai) Co., Ltd. (hereinafter referred to as “Microport® CRM”) has officially received the medical device registration certificate issued by the National Medical Products Administration (NMPA). It has become the first domestically produced ICD approved for marketing in China and is poised to be formally introduced into clinical practice.

It is reported that the implantable cardioverter defibrillators (ICDs) approved this time include two models: the dual-chamber PLATINIUM DR 1540 and the single-chamber PLATINIUM VR 1240.

Implantable Cardioverter Defibrillator (ICD) is an electronic device capable of automatically detecting and promptly terminating life-threatening tachyarrhythmias, such as ventricular tachycardia and ventricular fibrillation. It senses cardiac electrical activity via electrode leads; upon detecting abnormal arrhythmias, it delivers appropriately energized electrical shocks to restore normal cardiac rhythm, thereby preventing sudden cardiac death.

As a high-end medical device, the Implantable Cardioverter Defibrillator (ICD) presents exceptionally high technical barriers, demanding rigorous standards in electrocardiographic signal sensing and processing, high-energy storage and rapid discharge, lead technology, as well as miniaturization and reliability design.

Currently, the Chinese ICD market is dominated by imported products. Internationally renowned medical device companies such as Medtronic, Boston Scientific, and Biotronik have accumulated extensive technological expertise in the research, development, and manufacturing of ICDs, demonstrating superior performance in areas including the accuracy of arrhythmia monitoring, precise control of defibrillation energy, battery longevity, and lead wire performance. The recent approval and market launch of the PLATINIUM™ ICD marks a significant milestone in the accelerated catch-up of China’s domestic ICD market.

As the first domestically produced implantable cardioverter-defibrillator, the PLATINIUM™ ICD incorporates multiple breakthrough technologies that enhance energy efficiency. Compared to the typical 7–8-year service life of similar products, the PLATINIUM™ single-chamber ICD has an expected service life exceeding 14 years, while the dual-chamber ICD exceeds 13 years. This significantly reduces the frequency of device replacements, thereby lowering the risk of complications associated with replacement surgeries.

Meanwhile, the PLATINIUM™ ICD’s exclusive BTO and PARAD+™ algorithms can precisely identify ventricular arrhythmia events with a specificity of up to 99%, thereby reducing inappropriate therapies and alleviating patient discomfort. Specifically, the device features an advanced discrimination algorithm based on atrioventricular relationships (PARAD+) that accurately distinguishes supraventricular tachycardia, while the proprietary BTO algorithm enables physiological pacing within the tachycardia zone. Furthermore, the SafeR™ function intelligently manages atrioventricular conduction, significantly reducing unnecessary right ventricular pacing in patients (including those with atrioventricular block) and lowering the incidence of heart failure and atrial fibrillation associated with unnecessary right ventricular pacing.

It is worth mentioning that MicroPort® Sorin CRM has achieved multiple “firsts in China,” continuing to strengthen its presence in the field of cardiac rhythm management.

In 2015, MicroPort® CRM established China’s first domestically produced cardiac pacemaker production line aligned with advanced international standards.

In September 2017, MicroPort® CRM announced that its Rega™ cardiac pacemaker had officially received approval from the China Food and Drug Administration (CFDA), becoming the first domestically produced cardiac pacemaker in China with internationally advanced quality.

Among them, the XinYue™ Rega® series of implantable cardiac pacemakers measures only 8 cubic centimeters in volume, offers a battery life of up to 12 years, and provides advanced pacing features such as unique sleep apnea monitoring and SafeR physiological pacing; the XinYun™ Trefle® series of implantable cardiac pacemakers delivers advanced pacing capabilities including unique SafeR physiological pacing, comprehensive AT/AF management, and dual-sensor technology; while the XinLan™ Orchidee® series of implantable cardiac pacemakers provides standard pacing functions such as automatic AV interval and automated management, with its unique AUTOMRI feature simplifying the MRI examination process for pacemaker recipients.

Since the beginning of the 21st century, implantable cardioverter-defibrillators (ICDs) have achieved two significant advancements. First, with progress in electronic devices, ICDs equipped with remote monitoring capabilities have been introduced into clinical practice, enabling remote and scheduled monitoring of both the device and the patient, thereby enhancing postoperative management. Second, cardiac resynchronization therapy defibrillators (CRT-Ds) have been widely adopted; in addition to improving cardiac function, they also prevent sudden cardiac death (SCD). Furthermore, the clinical application of subcutaneous ICDs has further expanded therapeutic options.

Based on product type, implantable cardioverter-defibrillators (ICDs) can be classified into transvenous ICDs and subcutaneous ICDs.

Transvenous ICDs are implantable cardioverter-defibrillators in which the leads are implanted into the heart via veins. The leads enter through the veins and are typically positioned on the endocardial surface, while the pulse generator is generally implanted subcutaneously or submuscularly in the chest. In contrast, the leads of a subcutaneous ICD are entirely embedded subcutaneously without direct contact with the heart. These leads are usually placed along the parasternal line and the anterior axillary line, with the pulse generator typically implanted subcutaneously near the left midaxillary line. The device senses cardiac electrical activity via subcutaneous electrodes and delivers defibrillation shocks to the heart when malignant arrhythmias are detected.

Among these, transvenous ICD implantation requires venous puncture to advance the lead wires into the heart via the venous route, making the procedure relatively complex. The lead wires contact the endocardium, allowing for more direct sensing of cardiac electrical signals; however, this intracardiac contact also carries a risk of damaging blood vessels and cardiac tissue during implantation, potentially leading to complications such as pneumothorax (if lung injury occurs during venous puncture) and vascular injury.

The implantation procedure for a subcutaneous ICD is relatively simple, as it does not require venous puncture or entry into the heart. Instead, the electrode lead and pulse generator are primarily implanted in the subcutaneous tissue. Since the electrode is positioned subcutaneously and does not come into contact with the heart, direct injury to the heart and blood vessels is avoided.

Therefore, by comparison, the subcutaneous ICD (S-ICD) represents an innovative advancement in ICD technology. Currently, prominent international industry leaders have also established their presence in the S-ICD market. Among them, Boston Scientific’s EMBLEM™ MRI S-ICD System is the first subcutaneous implantable defibrillator that delivers effective defibrillation without the use of transvenous leads, offering a less invasive solution for patients at risk of sudden cardiac arrest.

In addition, new iterative directions have emerged in the field of cardiac rhythm management. For instance, AtaCor Medical, based in California, USA, has developed a fully extracardiac, minimally invasive temporary pacing system. The design of its AtaCor EV Temporary Pacing Lead System takes full account of human cardiothoracic anatomy, enabling temporary pacing without entering the heart, vascular system, or catheterization laboratory. This approach eliminates complications associated with transvenous leads and percutaneous pacing, thereby reducing patient discomfort. Currently, the company is expanding the application of the AtaCor EV Temporary Pacing Lead System to a broader range of cardiac therapies. In addition to providing anti-tachycardia pacing (ATP), AtaCor Medical is also utilizing this lead system for shock defibrillation, with all procedures performed without direct contact with the heart.

It is worth noting that among domestic innovative medical enterprises, in addition to Microport® Sorin CRM, Wushuang Medical is also a key player in the field of cardiac rhythm management. Its implantable cardioverter-defibrillator (ICD) features three major highlights: fully automatic operation, a compact design with simplified surgical procedures, and high defibrillation efficacy. The device can rapidly identify arrhythmias, provide stratified therapy, and integrates leading Bluetooth telemetry technology. Furthermore, empowered by Wushuang Medical’s proprietary advanced algorithms, the device offers superior discrimination capabilities for supraventricular tachycardia (SVT).

Reference: Chinese Expert Consensus on the Treatment with Implantable Cardioverter Defibrillators