The guidelines are introduced by NMPA Center of Medical Device Evaluation (CMDE). It is not legally binding but highly recommended by regulatory authorities. The revision plan will not only impact the new product registration but also renewals and modifications. It involves type testing, clinical, registration review guidelines, technical guidelines, e.g., Real World Study design, and documentation guidelines, e.g., Indication for Use (IFU) writing. 
NMPA issues new or updated guidelines throughout the year. Given their importance in understanding what the NMPA reviewers are looking for, it is essential that manufacturers keep up to date with the guidelines that are latest to their specific products. One source to get updates on these guidelines is through our complimentary monthly news roundup that you can opt in from our website www.ChinaMedDevice.com

TruLeaf Medical, Ltd, a fully-owned subsidiary of Allmed Solutions (TASE: ALMD), a clinical-stage medical device company specializing in transcatheter structural heart innovations, is pleased to announce the successful completion of the full two-stage percutaneous heart valve implantation procedure in two additional high-risk patients suffering from severe, refractory heart failure due to leaky tricuspid valve (TR). The first stage of the docking device implantation was performed 3 months ago. In recent days, the second stage of fully percutaneous transcatheter heart valve implantation within the TruLeaf RoseDocdocking station, was successfully performed at a leading medical center in India under a compassionate-use framework. This milestone achievement, conducted in collaboration with a prominent international medical device partner, further validates the clinical utility of TruLeaf Medical RoseDoc  TTVR system for high-risk, no-other-option patients suffering from severe refractory heart failure due to severe TR.

Although mViV demonstrated comparable 30-day MVARC outcomes, rSMVR was associated with superior long-term survival and hemodynamic durability among patients deemed appropriate surgical candidates by a multidisciplinary heart team. Treatment decisions should balance short-term risk with long-term outcomes.

Findings from the AltaValve Early Feasibility Study suggest that patients with a leaky mitral valve have sustained clinical benefits one year following atrial fixation Transcatheter Mitral Valve Replacement (TMVR). Researchers presented the late-breaking data at the Society for Cardiovascular Angiography & Interventions (SCAI) 2026 Scientific Sessions & Canadian Association of Interventional Cardiology/Association Canadienne de cardiologie d'intervention (CAIC-ACCI) Summit in Montreal.

The AltaValve was designed to minimize LVOT obstruction and work around the anatomical limitations of current TMVR technologyopens in a new tab or window, namely the transapical Tendyneopens in a new tab or window and transseptal Sapien M3opens in a new tab or window systems currently on the market.
Voudris noted that many TMVR systems rely on subvalvular fixation with rigid anchoring mechanisms. These increase the risk of LVOT obstruction and present anatomical limitations in people with complex mitral valve anatomy, large annuli, and mitral annular calcification (MAC), leading to infamously high screen failure ratesopens in a new tab or window associated with this technology.
The AltaValve instead relies on atrial fixation. It features a bovine pericardium valve within a stent frame, topped with a stent cap that is attached to the delivery system. An annular ring is designed for no active attachment to native mitral valve or left ventricular structures, and the ring comes in three sizes.

A novel transcatheter mitral valve replacement system designed for left atrial fixation rather than subvalvular fixation improved mitral regurgitation and functional outcomes in patients at high surgical risk, a speaker reported.
The system (AltaValve, 4C Medical Technologies) is designed to avoid left ventricular outflow tract (LVOT) obstruction and enable implantation in patients otherwise ineligible for transcatheter mitral valve replacement (TMVR) due to large valve annulus or mitral annular calcification, according to data presented at the Society for Cardiovascular Angiography & Interventions Scientific Sessions & Canadian Association of Interventional Cardiology/Association Canadienne de cardiologie d’intervention Summit.

The initial commercial availability of the HighLife TMVR system across Europe provides access to a transfemoral mitral valve replacement option featuring a dual-component valve-in-ring design, capable of treating the broadest range of native mitral annulus sizes (30–53mm) of any CE mark–approved TMVR system.
Clinical experience with the HighLife TMVR system includes patients treated across multiple countries, with longer-term follow-up data demonstrating durable outcomes, including sustained reduction of mitral regurgitation to mild or less; durable annular sealing enabled by a sub-annular ring fixation design, with no reported peri- or post-procedural paravalvular leakage PVL closure.

Presenting the latest results during a late-breaking trials session at PCR London Valves (16–18 November, London, UK), Vlasis Ninios (Interbalkan Medical Center, Thessaloniki, Greece) reported that, in a population of patients including many who would have been ineligible to receive other mitral valve technologies, implanters achieved a high rate of technical success with the procedure, resulting in symptomatic improvements for patients.
Left ventricular outflow tract (LVOT) obstruction is a common limitation of existing TMVR technologies leading to high rates of screen failure for patients screened for TMVR trials, Ninios highlighted in his presentation, ranking this alongside mitral annulus size and the presence of mitral annular calcification (MAC) as the exclusions that comprise the “Achilles’ heel” of existing TMVR technologies. AltaValve System’s atrial fixation TMVR device is designed to minimise the risk of LVOT obstruction and treat a broad population of mitral regurgitation (MR) patients as well as varied mitral annulus sizes.

Tricuspid regurgitation occurs when the tricuspid valve does not close properly, allowing blood to flow backward in the heart. The condition is common in older adults and can lead to worsening heart failure symptoms, repeated hospitalization and increased risk of death.
Historically, open-heart surgery was often the only treatment option for this condition, but many older patients were not candidates because of age or other medical problems. Today, transcatheter tricuspid valve replacement offers a less invasive alternative in which doctors replace the damaged valve using a catheter, or tube, threaded through a blood vessel.

Prior to this, ProStyle M® had undergone a two-year First-in-Man (FIM) study involving a total of 10 patients with a mean age of 71 years. The study results demonstrated excellent anchoring performance with no regurgitation observed in all cases. As the clinical study progresses, further evidence will be generated to verify the product's safety and efficacy.
KingstronBio takes innovation as its core driving force and has long been deeply engaged in the heart valve field. The company owns a number of patented technologies at home and abroad, including the Micro-Ex™ anti calcification treatment technology and AirBo™ dry storage technology for heart valves.

Auparavant, ProStyle M® avait fait l'objet d'une étude First-in-Man (FIM) de deux ans portant sur un total de 10 patients dont l'âge moyen était de 71 ans. Les résultats de l'étude ont démontré une excellente performance d'ancrage, aucune régurgitation n'ayant été observée dans tous les cas. Au fur et à mesure que l'étude clinique progresse, des preuves supplémentaires seront produites pour vérifier l'innocuité et l'efficacité du produit.
KingstronBio fait de l'innovation son principal moteur et est engagée depuis longtemps dans le domaine des valves cardiaques. L'entreprise possède un certain nombre de technologies brevetées dans le pays et à l'étranger, notamment la technologie de traitement anti-calcification Micro-Ex™ et la technologie de stockage à sec AirBo™ pour les valves cardiaques.

In a clinical trial comparing repeat mitral valve replacement surgery with a transcatheter valve-in-valve approach for dysfunctional bioprosthetic mitral valves, results linked the less invasive technique with a lower rate for death or stroke after 1 year. SURViV, is the first prospective clinical trial to compare the two procedures head-to-head. “Transcatheter mitral valve-in-valve has emerged as a less-invasive therapy for select high-risk patients,” he said. “Yet until now no trial has directly compared these two strategies.” The trial enrolled 150 patients with mitral bioprosthetic valve dysfunction between February 2020 and November 2023 and randomized them to redo surgery or transcatheter mitral valve-in-valve. The procedures were done at seven referral centers in Brazil. The primary composite endpoint of all-cause death and disabling stroke at 1 year was 20.8% for the surgery group and 5.3% for those who underwent valve-in-valve repair (P = .005), Siqueira said.

Transcatheter mitral valve-in-valve (mVIV) has emerged as a minimally invasive alternative to redo mitral valve replacement surgery (rMVR) in patients who cannot undergo repeat open-heart surgery. The mVIV procedure involves using a long flexible tube called a catheter to place a new prosthetic valve inside the patient's poorly functioning one. Until now, however, the outcomes of mVIV and rMVR had not been compared in a randomized, controlled trial, Siqueira said.

The AMEND™ System delivers a closed, D-shaped, semi-rigid annuloplasty ring through catheter in a transseptal approach. It is specifically designed to mimic the anatomical remodeling and clinical results achieved by traditional surgical annuloplasty—the technique used in most open-heart mitral valve repairs. Unlike other transcatheter mitral repair technologies, the AMEND System is designed to preserve future treatment options if clinically required later.

The Sapien M3 transcatheter mitral valve replacement (TMVR) system is indicated for the treatment of symptomatic moderate-to-severe or severe MR in patients who are deemed unsuitable for surgery or transcatheter edge-to-edge repair (TEER) therapy by a multidisciplinary heart team.

Heart valve replacement is a common cardiac procedure, but many patients and families ask one key question: what is the average age for heart valve replacement?
In most cases, heart valve replacement is performed between 60 and 75 years of age, although the exact age varies depending on the valve involved, the underlying heart condition, and the patient’s overall health.

Artificial intelligence combines ultrasound and X-ray images to give physicians a real-time 3D view of the repair device during transcatheter heart procedures.

The device, which can be deployed for transcatheter edge-to-edge repair (TEER) in the mitral or tricuspid valves, has similar design features to existing mitral TEER devices including MitraClip (Abbott) and Pascal (Edwards Lifesciences), and includes a mechanical closure system and central spacer. The device has received approval from China’s National Medical Products Administration (NMPA) and CE mark to date.

The study, which began enrolling in 2015, charts early use of the Intrepid device featuring a transapical delivery system, though later generations of the device have switched to using a transfemoral approach. Procedures were conducted at 21 sites spanning Europe, Australia and the USA and involved 95 patients with symptomatic severe MR who were at high risk for surgery.

Left ventricular outflow tract (LVOT) obstruction is a common limitation of existing TMVR technologies leading to high rates of screen failure for patients screened for TMVR trials, Ninios highlighted in his presentation, ranking this alongside mitral annulus size and the presence of mitral annular calcification (MAC) as the exclusions that comprise the “Achilles’ heel” of existing TMVR technologies. AltaValve System’s atrial fixation TMVR device is designed to minimise the risk of LVOT obstruction and treat a broad population of mitral regurgitation (MR) patients as well as varied mitral annulus sizes.

Over the past five years, we observed a 7.24% mortality rate at our tertiary care facility following prosthetic heart valve implantation across all age groups. The data suggest that mortality may be more common among females and older individuals; however, these differences did not reach statistical significance.

Minimally invasive cardiac procedures such as transcatheter aortic valve replacement (TAVR), catheter-based mitral valve repair, and percutaneous atrial septal defect closure fail at times to attract the same attention given to traditional open-heart surgeries, particularly high-profile procedures such as a coronary artery bypass graft. Studies like this one from the March 2021 issue of the Journal of Thoracic Disease discuss the debate over outcomes, quality, and safety that has followed these procedures.

Results of a pivotal clinical trial evaluating the safety and efficacy of a fully percutaneous transseptal mitral valve replacement (TMVR) procedure—Sapien M3 (Edwards Lifesciences)—in patients with symptomatic, moderate-to-severe mitral regurgitation (MR) who are not eligible for surgery or mitral-transcatheter edge-to-edge repair (M-TEER) procedures, demonstrated effective MR reduction with low rates of complications and mortality.