Buenos Aires, Argentina — On December 16, 2025, the AnchorMan^® Left Atrial Appendage Closure System (hereinafter referred to as "AnchorMan^®"), independently developed by Shanghai MicroPort CardioAdvent Co., Ltd, a wholly-owned subsidiary of MicroPort CardioFlow Medtech Corporation (02160.HK), successfully completed its first commercial clinical application in Latin America at the Instituto Cardiovascular de Buenos Aires (ICBA), a leading specialized cardiovascular hospital in Argentina.

The procedure was performed by a team led by the renowned expert, Professor LUIS IGNACIO MONDRAGÓN, at ICBA. Postoperative evaluation confirmed optimal device positioning with no residual leak or clinical complications, marking a complete success for the surgery.

Case Details

Preoperative CT Assessment:

The patient's left atrial appendage (LAA) exhibited a reverse chicken-wing morphology. The ostium was elliptical with a narrowed neck. The LAA ostium measured 11 mm, the pouch diameter was 14 mm, and the main lobe depth was 14 mm. A low and anterior interatrial septal puncture site was selected.

Intraoperative Procedure and Surgical Outcome:

LAA angiography was performed in RAO 30° CAU 20°, confirming a reverse chicken-wing anatomical structure. The widest part of the ostial pouch measured 13 mm with a depth of 14 mm. A 20 mm AnchorMan^® closure device was selected.

Device Deployment Process:

A combination of the "unsheathing method" and "push-pull technique" was employed. The delivery sheath was first advanced counterclockwise into the distal LAA. The closure device was then partially deployed using the unsheathing method, taking on a "bud-like" shape. Subsequently, using the push-pull technique, the device was slowly advanced distally. Leveraging the rounded, high-safety distal tip design of the AnchorMan^® LAAC system, the full depth of the appendage was utilized to achieve complete closure.

Surgical Outcome:

After deployment, the closure device conformed well to the LAA anatomy. A tug test confirmed stable device position without displacement. The compression ratio was ideal, and excellent immediate sealing was achieved.

Expert Evaluation:

Following the procedure, Professor LUIS IGNACIO MONDRAGÓN commented:

"The semi-closed structure combined with the rounded distal design of AnchorMan^® significantly enhances the smoothness and controllability of intraoperative manipulation. The device offers flexible movement and easy adjustment, which helps us better tackle the challenges posed by various complex LAA anatomies. It also contributes to reducing procedural difficulty and risk to some extent."

Summary:

Recently, while continuing to deepen its presence in the mainland China market, AnchorMan^® has successively expanded into the Hong Kong & Macau, European, and Latin American markets, achieving successful post-market clinical implants in Poland, Germany, and Argentina. This series of milestones signifies the product's steady entry into the global market for stroke prevention in atrial fibrillation and its growing recognition in the international arena.

Looking ahead, the company will accelerate the global commercial deployment of AnchorMan^® and fully leverage the resource integration and synergistic advantages brought by the strategic merger with MicroPort CRM. This will enable a concerted effort to build a globally leading integrated diagnosis and therapy platform spanning Structural Heart, Rhythm Management, and Heart Failure Management. Committed to building a leading enterprise of emerging technologies in cardiac diagnosis and therapy, the company aims to deliver innovative solutions to a broader global patient population.

For patients suffering from mitral regurgitation, every advancement in effective treatment means a redefinition of quality of life. On December 4, 2025, the one-year follow-up results from an early feasibility study (EFS) on the AltaValve system were officially released, bringing exciting news to the field of transcatheter mitral valve replacement (TMVR).

This research was presented by Dr. Vlasis Ninios from the Mediterranean Hospital of Thessaloniki, Greece, during the Late Breaking Trial session at the PCR London Valves conference held from November 16-18 in London, UK. The core conclusion is clear: The new supra-annular TMVR system, AltaValve, not only overcomes many limitations of existing technologies but also delivers sustained clinical benefits for patients over one year, offering hope especially to many patients who were previously ineligible for surgery.

Addressing the "Critical Shortcomings" of Existing TMVR, AltaValve Provides Precise Solutions

Many people may not be aware of the technical challenges in mitral valve replacement. In his presentation, Dr. Ninios specifically highlighted a major limitation—"Achilles' heel"—of existing TMVR technology: left ventricular outflow tract (LVOT) obstruction. This is a primary reason many patients fail pre-operative screening and cannot receive treatment. Additionally, issues like mitral annulus size and mitral annular calcification (MAC) also exclude numerous patients.

The core innovation of the AltaValve system lies in its targeted solutions to these pain points. Utilizing an atrial fixation design, it positions the prosthetic valve above the native mitral valve. This not only minimizes the risk of LVOT obstruction but also adapts to different annulus sizes, covering a broader spectrum of patients with mitral regurgitation (MR). Simply put, this device acts like a precisely "tailor-made" component for the heart valve, offering not only better adaptability but also reducing interference with other cardiac structures.

AltaValve^™ System: Redefining TMVR Treatment

4C Medical's core competitiveness stems from its independently developed AltaValve^™ system—a globally pioneering "atrial-only fixation" transcatheter mitral valve replacement (TMVR) device, and currently the only fully retrievable, low-profile transseptal TMVR system. This product addresses numerous pain points of traditional TMVR with three key advantages:

Expanding the Treatable Patient Population: Conventional TMVR is often limited by the degree of mitral annular calcification (MAC) or complex anatomy, excluding many high-risk patients. The AltaValve^™ uses a unique supra-annular positioning design, eliminating the need to replace the native mitral valve. It effectively adapts to patients with moderate/severe MAC and complex anatomy, significantly broadening the treatment scope.

Simplifying the Procedure and Enhancing Safety: Delivered via a transseptal approach and employing an "atrial-only fixation" mode, the system minimizes interference with critical left ventricular structures (such as chordae tendineae and the LVOT), significantly reducing the risk of procedural complications. Its low-profile, fully retrievable delivery system enables precise positioning and deployment, improving procedural success rates.

Preserving Native Cardiac Structure: Unlike traditional valve replacement, the AltaValve^™ does not require removal of the native mitral valve, preserving the mitral annulus and left ventricular function, thereby offering better protection for patients' long-term cardiac health. Early clinical trials show that most patients achieve complete elimination of mitral regurgitation within 30 days post-procedure.

Simple Procedure, Surprisingly Broad Patient Compatibility

Beyond its design advantages, the AltaValve procedure is also highly notable. Using a transseptal approach, the prosthetic valve consists of a nitinol stent frame housing a 27mm bovine pericardial tissue valve. Dr. Ninios described the implantation process as a "simple, straightforward single-step procedure": navigating via a steerable guidewire into the left atrium, curving to align with the mitral valve, and completing implantation from the annulus level towards the atrial roof. The entire process is adjustable and retrievable, greatly enhancing safety and precision.

Even more noteworthy is its broad compatibility. Study data show an anatomical acceptance rate of 77% for AltaValve. Among the 30 enrolled patients, over half (53%) had been rejected by other technologies due to LVOT stenosis risk, 27% had large annuli (>48mm), and 23% had moderate/severe MAC—all traditionally considered "contraindicated populations" for conventional TMVR, yet they found opportunity with AltaValve.

Impressive One-Year Follow-up Data: Safe, Effective, Sustained Benefits

Ultimately, clinical data measure the core value of a medical technology. This multi-center study across Europe, the US, and Japan enrolled patients at high surgical risk with symptomatic severe MR. 63% were female, with functional and degenerative MR patients equally represented. Initially, 13 patients were treated via a transapical approach, but the protocol has since shifted entirely to the less invasive transseptal approach (used in 17 patients in this study).

One-year follow-up results show a procedural technical success rate as high as 97%, with only one patient converted to surgery. Crucially, mitral regurgitation was completely eliminated in all patients. The mean mitral valve gradient decreased from a baseline of 2.5 mmHg to 2.1 mmHg post-procedure, indicating significant hemodynamic improvement. CT analysis also revealed that after AltaValve implantation, the neo-LVOT area increased by approximately 0.8 cm², and the valve annulus moved away from the LVOT during systole, effectively protecting native mitral valve function.

Safety outcomes were also excellent: one-year all-cause mortality was 17% in the transapical group but only 7% in the transseptal group. Cardiac mortality was 0% in the transseptal group. In the entire cohort, only one patient developed valve thrombosis due to non-compliance with medication, and one patient required a pacemaker. There were no incidents of stroke, new-onset atrial fibrillation, or mitral valve re-intervention. At one year, 96% of patients improved to NYHA functional class I or II, indicating a substantial enhancement in quality of life.

A Promising Future: Five-Year Follow-up and ATLAS Pivotal Trial Advancement

Dr. Ninios also mentioned a recent study published in JACC: Advances (led by Dr. Nadira Hamid of the Minneapolis Heart Institute, USA) showing that after AltaValve implantation, patients exhibited reverse remodeling with reduced left atrial volume and improved left atrial strain. This correlates with sustained improvements in NYHA class, Kansas City Cardiomyopathy Questionnaire (KCCQ) scores, and six-minute walk test results, further supporting its long-term benefit potential.

Currently, follow-up for this EFS will continue for five years. Concurrently, the ATLAS pivotal trial for AltaValve has begun enrolling patients in the US and Europe, aiming to include 100 MAC patients and up to 350 patients in the main cohort. "The one-year follow-up results demonstrate its sustained clinical benefits," Dr. Ninios concluded. "The TMVR field has faced many challenges for years. We hope the ATLAS trial will help us overcome these hurdles and bring hope to more patients."

About 4C Medical Technologies

Founded in 2015 and headquartered in Maple Grove, Minnesota, USA, 4C Medical Technologies is a medical device company focused on developing innovative, minimally invasive therapies for structural heart disease. With a core team boasting deep experience in the cardiovascular medical field, the company accurately identifies clinical pain points. It remains dedicated to R&D for interventional treatment solutions for mitral regurgitation (MR) and tricuspid regurgitation (TR), committed to breaking through traditional treatment bottlenecks through technological innovation, enabling more patients to benefit from safe and effective minimally invasive treatments.