OrbusNeich's Joint Venture Kicks Off TricValve Clinical Trial in Mainland China
The CE-marked medical device was named a Breakthrough Device and an Innovative Medical Device by the FDA in the United States and NMPA in China, respectively.
- The CE-marked medical device was named a Breakthrough Device and an Innovative Medical Device by the FDA in the United States and NMPA in China, respectively.
- It has effectively treated a 56-year-old patient with severe tricuspid regurgitation, marking the commencement of the clinical trial across Mainland China.
- Led by principal investigator Prof. Ge Junbo, Academician Zhongshan Hospital, Fudan University, and his team, the clinical trial aims to assess the safety and efficacy of TricValve.
- Mr. Peter Peh, General Manager of OrbusNeich P&F, said, "We are pleased to see TricValve moving into clinical trial, marking the first successful implantation of a percutaneous transcatheter bicaval device in a patient by cardiologists in Mainland China, to address severe tricuspid valve regurgitation.