On April 2nd, Abbott announced that the US FDA has approved the company's catheterized heart valve repair system TriClip for the treatment of tricuspid regurgitation (TR).
Tricuspid regurgitation is a blood reflux caused by the valve separating the lower right and upper right chambers of the heart not closing properly, which usually affects elderly people with various diseases, such as arrhythmia and high pressure in the heart and lungs. If these elderly people undergo open chest surgery, it can easily lead to complications and death.
Due to the complex anatomical structure of the tricuspid valve in the heart, it has always been a pain point in surgical procedures, and there is an urgent need for the development of interventional instruments to provide new treatment options.
In February of this year, Edwards Lifesciences' tricuspid valve replacement system was approved by the US FDA, becoming the first approved tricuspid valve intervention treatment device. However, Abbott's approved tricuspid valve system this time is a repair system that repairs the tricuspid valve by cutting off a portion of the valve, rather than completely replacing it.
Professor Ge Junbo, an academician of the CAS Member and director of the Department of Cardiology of Zhongshan Hospital affiliated to Fudan University, told China Business News: "The choice of replacement or repair should be based on the different conditions of the patient."
Nadim Geloo, Senior Director of Medical Affairs in Abbott's Structural Cardiology Department, stated that "repairing" valves is a "very proactive treatment approach.". He stated that 98% of patients receiving TriClip treatment did not experience significant adverse events within 30 days.
TriClip has also been approved to supplement Abbott's product line for heart valves, and the company expects the product to drive sales growth in the coming years. Abbott has not announced the clinical plan for this product in mainland China.
At present, there are no tricuspid valve treatment products approved in China. According to insiders from First Financial News, on March 28th, Ningbo Jianshi Technology revealed at a special exchange meeting aimed at investors that the current registration of the company's transcatheter tricuspid valve replacement product LuX Valve has not been approved by NMPA (National Medical Products Administration). The final registration result will be further reviewed and decided by the National Medical Products Administration, and additional clinical evidence may be required.
In response to the reason why LuX Valve was not approved, an industry insider explained to a reporter from First Financial News, "Now the Drug Administration requires all tricuspid valve products to undergo comparative studies with drugs, and currently there is no control group set up in clinical practice, so they will be returned for re clinical trials."
In addition to Jianshi Technology, Shanghai Huihe Medical is also developing a transcatheter tricuspid valve annulus repair system called K-Clip. The company stated that K-Clip has entered the "green channel" for special review of innovative medical devices in China and has completed registered clinical research. It has submitted a registration application to the National Medical Products Administration and is expected to be approved this year.
Tricuspid regurgitation accounts for approximately 60% of all tricuspid valve diseases. The number of newly diagnosed patients with moderate to severe tricuspid regurgitation in China exceeds 200000 each year, and the stock of tricuspid regurgitation patients exceeds 1 million. The reflux platform period can last for 10 to 15 years, and if left untreated, there is a risk of developing heart failure.
Currently, other options for treating this disease include using diuretics to prevent fluid accumulation in the body. Innovative tricuspid valve intervention instruments are expected to provide patients with better choices.
