Recently, the National Medical Products Administration approved the registration application for the innovative product "Transcatheter Tricuspid Ring Forming System" of Shanghai Huihe Medical Technology Co., Ltd. (hereinafter referred to as Huihe Medical).

Rich pipelines, multiple pioneering products launched
Huihe Medical was founded in 2019 and is a world leading cardiovascular intervention platform company with independent innovation capabilities. At present, Huihe Medical has four major platforms including delivery systems, clinical medical technology, precision manufacturing, and global marketing, all of which have industry-leading advantages. We have independently developed and world leading related products in the fields of heart valve intervention, vascular intervention, electrophysiological intervention, drug delivery intervention, and intelligent intervention.

The K-Clip approved for listing this time ® The transcatheter tricuspid annuloplasty system is the world's first transcatheter tricuspid annulus repair system independently developed by Huihe Medical, filling the gap in the field of tricuspid valve intervention in China and used to alleviate clinical symptoms of tricuspid regurgitation and heart failure in patients.

It is reported that the system includes a tricuspid annulus clamping system and a delivery sheath kit, where the tricuspid annulus clamping system includes clamping components, anchor components, and delivery systems, and the delivery sheath kit includes a delivery sheath and a dilator. The surgical procedure that originally required thoracotomy was performed through a vascular puncture approach, with minimal trauma, fast recovery, good results, and simple operation, with an average surgical time of only 30 minutes.

According to the China Listed Device Screening System database, except for the approved K-Clip ® In addition to the catheter assisted tricuspid valve ring shaping system, Huihe Medical has already achieved commercialization.

Among them, C-Wave ® The peripheral vascular shock wave waveguide system is a product under the umbrella of Huihe Medical, suitable for the treatment of intravascular calcifications. This product obtained the national NMPA registration certificate in 2023 and is the first domestically produced shock wave product. Moreover, the shock wave technology of this product can handle both internal and external seismic cracking and calcification, without causing damage to soft tissues.

In addition, Huihe Medical also has a potential product - L-Clip Transcatheter Mitral Valve Ring Repair System, which is currently undergoing confirmatory clinical trials. This product is also independently developed by Huihe Medical for the treatment of mitral regurgitation. It is the only device in the world suitable for functional mitral regurgitation, and has the characteristics of no need to cross the valve, only operating in the atrium, directly retracting the ring in situ, and easy operation.

In the early stages of the outbreak, filling the domestic gap
According to Frost&Sullivan data, the number of patients with tricuspid regurgitation (TR) worldwide is second only to mitral regurgitation patients, and is expected to affect over 50 million people worldwide in the future. The current prevalence of tricuspid regurgitation is over 0.62%, second only to mitral regurgitation and surpassing patients with aortic stenosis.

Based on the large number of patients, the volume of tricuspid valve intervention surgeries has also increased. The global number of transcatheter tricuspid valve interventions is expected to increase from 340 cases to 450000 cases between 2021 and 2030; The market size of tricuspid valve intervention devices will grow from 10 million US dollars to 11.28 billion US dollars, with a compound annual growth rate of 118.35%.

The domestic tricuspid valve intervention market is also the same. From 2023 to 2030, the overall market for tricuspid valve intervention devices will grow from 90 million yuan to 20.31 billion yuan, with a compound annual growth rate of 118.44%. It is expected that by 2030, the number of tricuspid valve intervention surgeries in China will reach 200000.

Faced with the rapidly growing and vast market, the first to enter the market is Edward's EVOQUE system, which was approved by the FDA in February 2024, becoming the world's first transcatheter tricuspid valve replacement product approved by the FDA; Abbott's TriClip followed closely behind, with the EVOQUE system receiving FDA approval two months later. However, unlike Edward's product, Abbott's product is a repair product, making it the first transcatheter tricuspid valve repair product to receive FDA approval.

Nowadays, there are also pioneers in China who have opened up the pattern of domestic intervention in the field of tricuspid valve treatment, followed by many enterprises such as Jianshi Technology and Qiming Medical.

LuX Valve Plus has made rapid progress among a range of products. This product is a new generation of transcranial tricuspid valve replacement system launched by Genesis Technology. It innovatively uses the transcranial vein as the surgical approach and utilizes interventricular septum anchoring and leaflet clamping technology to form its multiple anchoring structure without relying on radial support force. It effectively seals the atrial side to prevent valve leakage through adaptive braided rings, presenting better safety and effectiveness.

In the six-month follow-up data, the performance of LuX Valve Plus was also excellent, and its effectiveness and safety were preliminarily verified. The success rate is about 97%, and the average instrument operation time is 35.56 minutes. The effectiveness results showed that the grade of tricuspid regurgitation improved in all subjects, with 97.62% of patients showing no moderate or above regurgitation; The safety results showed that the incidence of composite events over a six-month period was only 8.33%.

Conclusion
With the support of policies and the promotion of continuous technological development, more and more blank areas have been filled by domestic innovative medical devices. With the increasing "gold content" of domestic medical devices, local medical devices are continuously shining with new light.

Source: https://news.yaozh.com/archive/45134.html