Milestone Achieved: China's First Transcatheter Tricuspid Valve Repair Device, K-Clip®, Approved for Market
H&H Healthcare
R&D and Producer of Interventional Medical Devices for Heart Disease
Recently, the K-Clip Transcatheter Tricuspid Annuloplasty Repair System, independently developed and globally首创 by Shanghai Huihe Healthcare Technology Co., Ltd. (referred to as HuiHe Healthcare), has officially received approval from the National Medical Products Administration (NMPA) for market launch!
Thus, K-Clip fills the gap in China's interventional tricuspid valve field and becomes the first domestically certified transcatheter treatment product for tricuspid regurgitation. K-Clip also ushers in a new era of global TTVA (Transcatheter Tricuspid Valve Annuloplasty) treatment for tricuspid regurgitation, leading international academic research trends.
In the field of structural heart disease, the tricuspid valve has been relatively late to achieve interventional treatment due to its complex pathological mechanisms and the high risks associated with traditional treatments. In recent years, with technological advancements and the accumulation of evidence-based medical data, transcatheter procedures for the tricuspid valve are gradually becoming a focal point in the cardiovascular field.
In June 2018, a corkscrew like Newton's apple illuminated the sudden inspiration for transcatheter tricuspid valve annuloplasty (TTVA). HuiHe Healthcare ingeniously designed the K-Clip, which, through an interventional approach, simply and cleverly replicates the surgical Kay’s procedure. The original surgery required opening the chest to fold and reduce the enlarged tricuspid valve annulus but has now been improved to a minimally invasive procedure requiring only venous puncture.
Since 2018, K-Clip has evolved from hand-drawn sketches through more than 100 iterations, over 2,500 product tests, more than 5,000 design drawings, and the validation involving more than 380 large live animals, finally giving birth to the clinically applicable K-Clip Transcatheter Tricuspid Annuloplasty Repair System.
The team of Academician Ge Junbo from Zhongshan Hospital Affiliated to Fudan University
On April 21, 2021, the team of Academician Ge Junbo from Zhongshan Hospital Affiliated to Fudan University, together with Professor Zhou Daxin, Professor Pan Wenzhi, Professor Zhang Xiaochun, Professor Pan Cuizhen, and Professor Li Wei, successfully completed the first human implantation of the K-Clip Transcatheter Tricuspid Annuloplasty System. Subsequently, they completed 33 FIM (First-in-Man) cases. In October of the same year, K-Clip passed the special approval application for innovative medical devices by the National Medical Products Administration (NMPA) Center for Medical Device Evaluation, entering the "green channel" of the approval process.
In May 2022, K-Clip officially launched the TristarI single-group target value registration clinical study in China; in March of the following year, K-Clip initiated the TristarII randomized parallel controlled registration clinical study; and completed the 1-year follow-up in 2024. [Research institutions include: Zhongshan Hospital Affiliated to Fudan University, Second Affiliated Hospital of Zhejiang Medical University, Fuwai Hospital of Chinese Academy of Medical Sciences, Beijing Anzhen Hospital Affiliated to Capital Medical University, First Affiliated Hospital of Zhejiang Medical University, Guangdong Provincial People's Hospital, West China Hospital of Sichuan University, Anhui Provincial Hospital, and 16 other cardiac centers.]
Proven by Two Studies of TriStar: K-Clip®Effectiveness and Safety of Transcatheter Tricuspid Annuloplasty System for Treating Severe and Above Tricuspid Regurgitation. One-year follow-up data show that K-Clip can significantly and continuously reduce the severity of tricuspid regurgitation, promote right heart remodeling, significantly improve cardiac function, and enhance patients' quality of life.
With K-Clip®The TTVA procedure, represented by the transcatheter tricuspid annuloplasty repair system, is a preferred treatment option for patients with severe tricuspid regurgitation primarily caused by annular dilation. Meanwhile, in patients with severe right heart dysfunction, K-Clip...®Can serve as a "bridging treatment" for TEER or TTVR procedures, preventing the occurrence of acute right heart failure and giving patients hope for survival.
The launch of K-Clip is not only a technological breakthrough in China but also a milestone event in the global treatment of tricuspid regurgitation!
The launch of K-Clip has redefined the treatment paradigm for tricuspid regurgitation, significantly advancing the TTVA procedure.
For patients, it represents a leap in survival hope and quality of life; for doctors, it signifies the liberation of clinical decision-making freedom; for surgical procedures, it marks the beginning of an era of efficient and precise treatment. In the future, with the popularization of technology and the accumulation of experience, there is hope to combine atrial fibrillation ablation and left heart valve intervention to explore a "one-stop" solution for complex cardiac lesions.