Recently, the National Medical Products Administration approved registration applications for two innovative medical devices, namely: the percutaneous glomerular filtration rate measurement device from Meidekang Company (hereinafter referred to as Meidekang) and the disposable balloon cryoablation catheter from Xinuopu Medical Technology (Beijing) Co., Ltd. (hereinafter referred to as Xinuopu Medical).

Meidekang: Combination of medicine and equipment to meet clinical needs
MediBeacon was founded in 2012 and is dedicated to the research and development of medical optical diagnostic products, mainly involving fluorescent contrast agents and corresponding equipment. In 2019, East China Pharmaceutical invested 30 million dollars in Medecin, and obtained the exclusive commercialization rights of all Medecin products (including the follow-up development of new products) in 25 Asian countries or regions, including Chinese Mainland, Hong Kong, Taiwan, Singapore, and Malaysia, so as to layout the field of renal function monitoring.

The approved percutaneous glomerular filtration rate measurement device - MediBeacon ® The Transdermal GFR System (TGFR) is the world's first product developed in collaboration between Huadong Pharmaceutical and Meidekang. It was previously granted breakthrough medical device certification by the FDA in October 2018 and was approved for market by the FDA in January of this year.

The current clinical methods for detecting glomerular filtration rate in patients with impaired or normal kidney function have various shortcomings, such as long time to obtain test results, large equipment leading to strong site limitations, and the need for multiple sampling. However, TGFR and Lumitrace injection ( ®， A non radioactive, non iodinated fluorescent GFR tracer, also jointly developed by Huadong Pharmaceutical and Meidekang, can be used in combination to solve such drawbacks and is expected to address unmet clinical needs.

It is reported that TGFR consists of a monitoring device, sensors, and remibizine injection, aiming to evaluate the glomerular filtration rate (GFR) of adult patients with impaired or normal kidney function by non-invasive monitoring of the fluorescence values of exogenous tracers over time. Its effectiveness has been validated in patients with stable kidney function.

This product can evaluate renal function by measuring the in vivo clearance rate of fluorescent tracers, and real-time calculation of transdermal Lumitrace through sensors placed on the skin surface ® The monitoring method used for fluorescence intensity as a function of time is not affected by age, weight, gender, or race.

Moreover, the sensors in the system can record 2.5 fluorescence values per second, and the TGFR monitor can provide the average GFR value for hospitalized or outpatient patients during the corresponding time period. The design of TGFR has been clinically validated for bedside assessment of GFR in patients with stable renal function, without the need for blood or urine analysis.

With the approval of TGFR, its advantages of simple operation, non-invasive, fast, accurate, and repeatable measurement have broken through the time and space limitations of existing GFR detection methods. It has breakthrough significance for the diagnosis and treatment of clinical application scenarios related to renal dysfunction, greatly improving the efficiency and convenience of clinical kidney disease detection, and benefiting more clinical diagnosis and treatment patients who need renal function monitoring.

Xinnopu Medical: Cryoablation Products
Xinnopu Medical, founded in 2005, has been focusing on the field of cardiac electrophysiology for nearly 20 years and continues to lead industry technological innovation. It is a leader in the Chinese atrial septal puncture market. At present, Xinnopu Medical's existing products cover dozens of categories including atrial septal puncture instruments, diagnostic instruments, and therapeutic instruments, and have established a complete business system covering research and development, manufacturing, and sales.

Xinnopu Medical is actively promoting revolutionary innovation projects such as cryoablation system (Nordica), 3D mapping system (Meridian), intracardiac ultrasound (ICE) diagnostic catheter and equipment (enVision) with the innovation research and development center in the United States as the engine, comprehensively improving surgical outcomes, continuously enhancing the safety and effectiveness of atrial fibrillation surgery, continuously improving the clinical operation experience of surgeons, and benefiting the vast number of cardiovascular disease patients.

In addition, it is worth mentioning that Xinnopu Medical received nearly 300 million yuan in financing in December 2024, which aims to support Xinnopu Medical's innovative pipeline and international business development.

The disposable balloon cryoablation catheter approved for market this time consists of a balloon cryoablation catheter and a manual retraction kit. It adopts a special fluid injection device and pressure monitoring technology inside the balloon. The special fluid jet device can ensure uniform distribution of surface temperature on the anterior hemisphere of the balloon, achieving effective ablation; The pressure monitoring technology inside the balloon can ensure stable contact of the balloon and achieve stable internal pressure of the balloon. This product can effectively reduce the risk of balloon bouncing and displacement caused by pressure fluctuations during ablation, benefiting more patients with paroxysmal atrial fibrillation.

This product is used in conjunction with a cryoablation device produced by the same company, mainly for the treatment of drug-resistant, recurrent, and symptomatic paroxysmal atrial fibrillation in adult patients. The cryoablation device was approved for market on January 20th of this year. The instrument consists of a host, coaxial fluid connecting tube, and connecting cable, and is used in conjunction with the approved balloon cryoablation catheter. It adopts pressure flow dual control technology to achieve pressure stability of the balloon during inflation and ablation processes by real-time monitoring and control of refrigerant flow and balloon pressure.
It is reported that this technology can effectively reduce the risk of bouncing and displacement caused by pressure fluctuations during the occlusion and ablation of pulmonary veins, and is used for the treatment of drug-resistant, recurrent, and symptomatic paroxysmal atrial fibrillation in adult patients.

Source: https://news.yaozh.com/archive/45026.html