Peijia Medical has announced that its TaurusTrio transcatheter aortic valve (TAV) system received approval from the National Medical Products Administration (NMPA) of China.
The TaurusTrio TAV system is developed and manufactured by Peijia Medical under an exclusive license from JenaValve Technology (JenaValve) for its Trilogy transcatheter heart valve (THV) system. It is designed to treat patients with native symptomatic severe aortic regurgitation (AR) via transfemoral access.
Unlike in patients with aortic stenosis, in patients with AR, there is often no calcification for the transcatheter system to anchor onto, leaving AR patients with limited treatment options. The TaurusTrio system incorporates JenaValve’s proprietary locator technology, which enables stable anchoring by engaging the native aortic leaflets even in the absence of calcium, while ensuring commissural alignment.
The one-year clinical results from the TaurusTrio ALTER-AR study demonstrated a technical success rate of 99.1%, with 0% all-cause mortality at 30 days and only 2.6% at one year. Patients showed significant cardiac function improvement, with 91.7% recovering to New York Heart Association (NYHA) class I/II at six months. The incidence of moderate or greater paravalvular leak was 0% at one year, and indicators such as left-ventricular end-diastolic volume (LVEDV) and left ventricular mass (LVM) showed significant reverse remodelling, validating the device’s long-term safety and efficacy.
“Historically, many patients with severe, pure AR who are ineligible for surgery have lacked an ideal interventional treatment—leaving a significant unmet clinical need,” said Yi Zhang, chairman and chief executive officer of Peijia Medical. “By proactively introducing JenaValve’s unique locator technology, we directly tackled the core challenge of ‘unstable anchoring’. This gives physicians a vital new tool and finally offers patients a dedicated, long-awaited solution, moving AR treatment decisively into a new phase. The approval also exemplifies our strategy to commercialise cutting-edge technologies and build a local innovation ecosystem, reflecting the deep integration of global expertise and Chinese execution.”
John Kilcoyne, chief executive officer of JenaValve, commented: “It is a great pleasure to witness the NMPA approval of TaurusTrio, which validates the extraordinary effort invested over the years to introduce this system to China. As the leading transcatheter valve for AR, TaurusTrio provides new hope to millions of patients who previously had few viable options. This achievement reaffirms our shared goal with Peijia Medical: to ensure that patients with AR, a long-underserved community, finally receive the treatment they need and deserve. On behalf of the entire JenaValve team, I would like to extend our sincere appreciation to the Peijia China team. Together, let us continue to advance our shared mission of improving patients’ lives.”
JenaValve’s Trilogy THV system received CE mark approval in May 2021 and has been used in over 1,000 commercial procedures. Results from an expanded cohort of 700 patients from the ALIGN-AR pivotal trial for the Trilogy system in high-risk patients with symptomatic, severe AR were published in The Lancet and presented at PCR London Valves (16–18 November, London, UK) last month.
