Recently, the National Medical Products Administration approved the registration applications for two innovative products, the "implantable cardiac pacing electrode lead" of Chuangling Heart Rhythm Management Medical Equipment (Shanghai) Co., Ltd. (hereinafter referred to as "Chuangling Heart Rhythm Medical") and the "zirconia ceramic femoral head" of Beijing Ansong Technology Co., Ltd. (hereinafter referred to as "Ansong Technology").

Chuangling Heart Rhythm Medical, the first domestically produced product launched
Chuangling Heart Rhythm Medical was established in 2014, dedicated to the research and development, manufacturing, and management of medical devices related to heart rhythm diseases, providing corresponding technical services and consulting, and conducting sales and import/export business of medical devices. The company strives to become the preferred brand for domestic pacemakers, providing high-quality heart rhythm management products and services for patients in China and even the world, improving their quality of life, and extending their lifespan.

The BonaFire approved this time ® Implantable cardiac pacing electrode lead (hereinafter referred to as BonaFire) ® The electrode lead is the first domestically produced whole-body magnetic resonance condition safe pacing electrode lead, consisting of electrode lead and accessories, combined with a matching cardiac pacemaker to form an implantable cardiac pacing system, mainly used for pacing and sensing of the atrium and ventricle.

It is understood that pacing electrode leads are an important component of cardiac pacing systems, and their design and production processes are extremely complex, with research and development challenges and difficulties no less than those of pacemakers themselves. Based on the clinical service life requirements of electrode wires, a single electrode wire usually needs to be bent at least 700 million times with the heartbeat, during which problems such as insulation layer rupture, conductor material fracture, and connection end disconnection cannot occur. Therefore, the material's fatigue resistance, durability, biocompatibility, and production process requirements are extremely high.

BonaFire ® Electrode leads can effectively reduce the temperature rise of myocardial tissue during MRI scanning, which can better meet the clinical needs of 1.5T magnetic resonance imaging in patients with arrhythmia. Its design is completely in accordance with international standards, with a 6F diameter lead body that is easy to pass through thinner blood vessels, and uses advanced technology and materials in the industry, including steroid eluting hormone slow-release, titanium nitride coating, silicone rubber insulation layer, etc. As a bipolar electrode wire, BonaFire ® Electrode leads can provide stable sensing and pacing, as well as clinical examination conditions for whole-body magnetic resonance imaging (MRI) for patients.

BonaFire ® The launch of electrode leads is of great significance to the medical device field in China. Currently, MRI compatible pacemakers have become the mainstream of the industry. However, there have been no domestically produced MRI compatible cardiac pacing electrode leads launched in China before, so the MRI compatible pacing systems used in clinical practice in China mainly rely on imports. BonaFire ® The electrode lead market will effectively fill the domestic gap of MRI compatible electrode leads and is expected to provide a fully domestically produced MRI compatible cardiac pacing system from pacemakers to electrode leads for clinical use.

Ansong Technology fills the domestic gap
Ansong Technology was founded in 2017, focusing on the design, research and development, production, and sales of artificial joint prostheses and devices. Its independently developed artificial ceramic hip joint prostheses have broken the technological monopoly of foreign manufacturers and filled the domestic gap. In the process of domestic substitution of imported products, Ansong Technology has a monopolistic advantage.

The Article approved this time ® The zirconia ceramic femoral head product is a hip joint prosthesis component made of zirconia ceramic material, which is compatible with the same series of components from the same company and suitable for hip joint replacement. By adopting high and low temperature cycling sintering technology, the high temperature of sintering is reduced, which not only provides driving force for grain boundary diffusion, but also avoids the problem of poor performance caused by high temperature. Compared with metal femoral heads, the chemical inertness of zirconia ceramic femoral heads can effectively prevent the release of metal ions, reduce the occurrence of prosthesis loosening problems, and also have better biocompatibility.

This product also has excellent product performance, with outstanding performance in terms of product strength, resistance to fragmentation risk, and resistance to friction and wear. It is worth mentioning that this product is also the first domestically developed ceramic joint to be approved in 20 years, filling the domestic gap.

It is reported that Article ® Zirconia ceramic femoral head products have undergone more than 20 years of research and development, with a Harris score excellent rate of 100% at 3-year follow-up after surgery and a prosthesis survival rate of 100% at 4-year follow-up after surgery. Thanks to the approval of this product, Ansong Technology has become the only innovative enterprise in China that can provide joint ceramic products and materials.

In addition to zirconia ceramics, Ansong Technology's alumina ceramic (yellow ceramic) femoral head has also completed clinical trials and applied for registration; Zirconia toughened alumina (powder ceramic) femoral heads have also completed performance testing and are preparing for clinical trials before applying for listing. If the above two products are successfully launched, Ansong Technology will become the only global manufacturer that can provide three types of ceramic joints at the same time, providing more treatment options for peers and partners.

Conclusion
The two products approved this time are both the first domestically produced products, which not only fill the domestic gap, but also greatly accelerate the process of domestic substitution. With the acceleration of China's medical device innovation, more innovative products will emerge in the future, and the Chinese medical device industry is continuously accelerating towards the goal of high-quality development.

Source: https://news.yaozh.com/archive/44588.html