On October 10, 2026, the National Medical Products Administration (NMPA) granted registration approval to Beijing Bairui Medical Technology Co., Ltd. for its transcatheter pulmonary valve system (Registration No.: 20263132078). Three days later, Bairui Medical disclosed the product’s technical details and market positioning via a public announcement as a listed company. This marks its third transcatheter valve device cleared through NMPA’s Special Review Procedure for Innovative Medical Devices, following the transcatheter aortic valve system (approved in 2024) and the transcatheter valve-in-valve system (approved in 2025). The company has secured approvals for three valve positions within two years.

Unlike transvascular TPVR products already approved in 2022 such as VenusP-Valve by Venus Medtech, Bairui Medical adopts a transthoracic small-incision approach, integrating surgical main pulmonary artery remodeling and transcatheter valve implantation into a single hybrid procedure. This technical pathway addresses a longstanding challenge in the TPVR space: a substantial share of patients present with highly complex right ventricular outflow tract anatomy that cannot accommodate anchoring requirements for existing transvascular devices.

A Long-Term Clinical Challenge After Complex Congenital Heart Surgery

Nearly all patients requiring pulmonary valve replacement share a distinct clinical history. Patients with complex congenital heart defects such as tetralogy of Fallot undergo corrective surgery during infancy, where surgeons typically enlarge the stenosed right ventricular outflow tract using biologic patches or autologous pericardium for repair. While the procedure is life-saving, patients are often left without a functional pulmonary valve. As patients grow older, pulmonary regurgitation progresses gradually, increasing right ventricular volume load and impairing ventricular function, which ultimately necessitates valve replacement.

Bairui Medical cited a dataset in its announcement: since public records became available in 2011, approximately 300,000 complex congenital heart surgeries have been performed in China, and the vast majority of these postoperative patients are candidates for TPVR. Re-do open-heart surgical valve replacement has long been the standard management, while TPVR offers a less invasive alternative for selected patients.

The core limitation lies in the altered anatomy of the right ventricular outflow tract and main pulmonary artery from prior operations. These structures vary widely in diameter, length and geometric configuration: some are excessively dilated, others are irregular, and patched segments often lack adequate structural support. Conventional transvascular TPVR devices rely on stable anchoring within these anatomical structures, yet a considerable proportion of patients do not meet the anatomical criteria. Industry data referenced by Bairui Medical indicates that existing TPVR products are anatomically suitable for only roughly 20%–30% of patients.

Instead of Fitting Valves to Malformed Anatomy: Remodel First, Then Implant

Bairui Medical’s solution adopts a reversed logic: rather than designing the valve to adapt to a malformed main pulmonary artery, the procedure reshapes the vessel into near-normal anatomy before deploying a valve engineered to mimic native physiology.

In practice, clinicians identify the optimal transthoracic access site via pre-procedural imaging. A small incision is made at the pulmonary conus on a beating heart. The main pulmonary artery is surgically remodeled under direct vision, after which the valve is delivered and released via catheter. According to the company, this approach improves coaxial alignment during device delivery, eliminates risks associated with crossing the tricuspid valve through a peripheral vascular route, and removes the need for the valve stent to prioritize high flexibility, enabling stronger radial support.

It is critical to clarify that this is a hybrid procedure combining surgical and interventional techniques, not a fully percutaneous intervention. It requires a thoracic incision and cardiac surgical manipulation, demanding close collaboration between cardiology and cardiac surgery teams. Bairui Medical positions the product as an “all-comer” solution, claiming that any main pulmonary artery morphology can be remodeled to enable stable device anchoring. However, the approved NMPA indication carries explicit restrictions: patients must be at least 9 years old and weigh ≥20 kg, have a history of complex congenital heart surgery, retain their native right ventricular outflow tract, and present with severe pulmonary regurgitation. Additional anatomical criteria include a main pulmonary artery diameter of at least 16 mm and length of at least 20 mm. Regulatory documentation also specifies that this therapy is not a substitute for open cardiac surgery.

Mid-Term Follow-Up of 38 Patients: Preliminary Signals and Evidence Boundaries

Clinical evidence supporting the product is primarily derived from a prospective study published in Catheterization and Cardiovascular Interventions in March 2025. Conducted at Guangdong Provincial People’s Hospital, the trial enrolled 38 patients who received transthoracic implantation of the Salus self-expanding pulmonary valve between September 2021 and September 2024, with a mean age of 24.08 ± 8.12 years and an enrollment age cutoff of 14 years or older.

Successful implantation was achieved in all 38 procedures, though 3 cases of intraprocedural valve migration occurred. At a median follow-up of 24 months, no deaths or reinterventions were observed. Right ventricular end-diastolic volume index (RVEDVI) decreased from 141.45 mL/m² to 109.98 mL/m², and right ventricular end-systolic volume index (RVESVI) fell from 74.27 mL/m² to 56.62 mL/m²; both reductions were statistically significant (p<0.01). The Kaplan–Meier estimate for freedom from major adverse events at 36 months was 87.2%.

While these results deliver preliminary safety and efficacy signals, several evidentiary limitations must be acknowledged. This is a single-center, non-randomized cohort with a small sample size, and direct cross-product efficacy comparisons against other TPVR devices are not feasible. The original study enrolled patients aged 14 and above, whereas the approved indication extends down to 9 years of age; clinical data for younger pediatric patients remains limited. The 36-month freedom-from-adverse-event estimate is generated by the Kaplan–Meier method and does not represent complete three-year follow-up for all subjects. The 3 intraprocedural valve migration events also require further evaluation of incidence and management in larger cohorts.

The Top Concern for Young Patients: Valve Durability

Unlike TAVR, which largely serves elderly patients with aortic stenosis, TPVR recipients are predominantly adolescents and young adults. A valve lasting a decade may be sufficient for a 70-year-old patient, but for a 20-year-old patient, it likely means multiple reinterventions over a lifetime.

In its announcement, Bairui Medical highlights that the valve leaflets use the same bovine pericardial material and anti-calcification technology deployed in its surgical bioprosthetic valves with over 20 years of commercial history. A patented leaflet commissure suture technique delivers in-vitro opening-closing kinematics and fatigue performance matching those of surgical bioprostheses. Based on this, the company posits that the device may deliver comparable durability.

This inference warrants cautious interpretation. Accelerated bench fatigue testing and long-term real-world performance of surgical bioprostheses provide indirect reference, yet the in-vivo hemodynamic environment and stent-leaflet interaction for transcatheter valves differ from those of surgically implanted bioprostheses. Definitive conclusions on durability must await long-term clinical follow-up data specific to this device.

Bairui Medical also introduces the concept of “full-lifecycle management”: a remodeled, near-normal main pulmonary artery creates a stable landing zone for future valve-in-valve procedures. While logically sound, this strategy still requires long-term surveillance and real-world reintervention cases for validation.

After Two Years and Three Transcatheter Valve Approvals

From a product portfolio perspective, Bairui Medical’s three innovative transcatheter valves cover the aortic valve position, degenerated valves for valve-in-valve indications, and the pulmonary valve position. For a company founded on surgical bioprosthetic valves, this represents a systematic expansion into transcatheter heart valve therapy. The domestic TPVR market already features VenusP-Valve from Venus Medtech; the two product lines differ in access route, valve design and target patient populations, and no head-to-head comparative data is available to date.

Bairui Medical acknowledged in its announcement that post-launch commercial performance is subject to uncertainties including market adoption, regional clinical capacity and medical insurance coverage. The hybrid transthoracic pathway imposes stringent requirements on surgical teams and operating room infrastructure, another practical barrier to widespread clinical uptake. Regulatory approval of the three valves marks only the starting point; commercialization pace will determine whether technological innovation translates into meaningful clinical adoption. For this pulmonary valve system, larger-scale, long-term real-world data will supply the critical evidence to answer the core questions raised by clinicians and patients.

October 17，2026