Peijia Medical Receives NMPA Approval for TaurusTrio Transcatheter Aortic Valve System for Aortic Regurgitation Treatment
核心洞察
Peijia Medical's TaurusTrio transcatheter aortic valve system received NMPA approval on December 11, 2025, marking the first dedicated treatment for severe aortic regurgitation in China.
The ALTER-AR study demonstrated exceptional clinical outcomes with 99.1% technical success rate, 0% mortality at 30 days, and 91.7% of patients recovering to NYHA class I/II at six months.
The system incorporates JenaValve's proprietary locator technology that enables stable anchoring without calcification, addressing a significant unmet medical need for AR patients.
Peijia Medical (9996.HK) announced that its TaurusTrio Transcatheter Aortic Valve (TAV) system received approval from China's National Medical Products Administration (NMPA) on December 11, 2025, marking a significant breakthrough in treating patients with severe aortic regurgitation (AR). The approval addresses a critical unmet medical need for AR patients who previously had limited treatment options due to the unique challenges of anchoring transcatheter valves in the absence of calcification.
Revolutionary Technology for Challenging Cases
The TaurusTrio system is developed and manufactured by Peijia Medical under an exclusive license from JenaValve Technology (搜索), Inc. for its Trilogy Transcatheter Heart Valve System. The device is specifically designed to treat patients with native symptomatic severe aortic regurgitation via transfemoral access, incorporating JenaValve's proprietary locator technology that enables stable anchoring by engaging the native aortic leaflets even without calcium deposits while ensuring commissural alignment.
Unlike patients with aortic stenosis, those with AR often lack the calcification that traditional transcatheter aortic valves rely on for anchoring, creating a significant treatment challenge. The TaurusTrio system's innovative approach directly addresses this core issue of "unstable anchoring" that has historically limited interventional options for AR patients.
Exceptional Clinical Outcomes
The one-year clinical results from the TaurusTrio ALTER-AR study demonstrated remarkable safety and efficacy outcomes. The study achieved a technical success rate of 99.1%, with 0% all-cause mortality at 30 days and only 2.6% mortality at one year. Patients showed significant cardiac function improvement, with 91.7% recovering to NYHA class I/II at six months.
The device demonstrated excellent hemodynamic performance with 0% incidence of moderate or greater paravalvular leak at one year. Additionally, key cardiac remodeling indicators including left ventricular end-diastolic volume (LVEDV) and left ventricular mass (LVM) showed significant reverse remodeling, validating the device's long-term safety and efficacy.
Industry Leadership Perspectives
"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 Dr. Yi Zhang, Chairman and CEO 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."
John Kilcoyne, CEO of JenaValve, emphasized the global significance of this approval: "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."
Global Clinical Experience
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 THV System in high-risk patients with symptomatic, severe AR were published in The Lancet and presented at PCR London Valves.
Market Impact and Future Outlook
The approval represents a major milestone for Peijia Medical, reflecting the company's dedication to structural heart disease innovation and commitment to addressing clinical needs. This achievement signifies a key technological breakthrough in China's interventional treatment landscape, offering patients the prospect of longer survival and better quality of life.
With wider clinical adoption, AR care in China will enter an era of precision, minimally invasive therapy, strengthening patient protection and exemplifying a collaborative model for domestic medical device innovation. Peijia Medical, established in 2012 and headquartered in Suzhou, China, now has four TAVR systems and nearly twenty neurointerventional devices registered in China, positioning the company as a leading platform for comprehensive structural heart and neurovascular disease treatment solutions.