First-in-America Implantation of AMEND Annuloplasty Ring in Mitral Regurgitation, With Paul Sorajja, MD

Valcare Medical, Ltd.’s AMEND annuloplasty ring, a closed D-shaped semi-rigid device built to mimic the surgical gold standard of mitral regurgitation (MR) treatment, has been successfully implanted in a patient for the first time in the US.1

In a procedure led by Paul Sorajja, MD, associate director of the Banner Heart Institute and Lentsch Family Endowed Chair, Service Line for Valvular Heart Disease at Banner Health, the ring was applied via a catheter inserted through a vein in the leg and crossed over from the right to the left side of the heart. The ring is the same size and shape as those typically used during open cardiac surgery, allowing this procedure to circumvent the need for stopping the heart.1

The HCPLive editorial team met with Sorajja to discuss the operation, the AMEND ring’s functionality and effectiveness, and the probable next steps for the device’s testing and potential inclusion in pivotal clinical trials.

“I think the AMEND ring has the ability to really transform the field in a big way, because it’s the one piece of our toolbox that we really need as interventionists,” Sorajja told HCPLive. “Surgeons essentially try to put rings in patients every time they try to repair mitral valves, and we know the outcomes are better in patients who get rings than those who don’t. The ability for us to be able to do this from an interventional standpoint through the groin is really pioneering.”

The full system, called the AMEND Trans-Septal System, received approval from the US Food and Drug Administration (FDA) for investigational device exemption on March 13, 2025. An Early Feasibility Study began on September 11, 2025, and is currently recruiting patients, sponsored by Valcare Medical. The study aims to enroll ≤15 participants in ≤7 sites between the US and Canada and is projected to last 5 years.1,2

The primary endpoint for the feasibility study is a composite of mortality, including all-cause death, stroke, myocardial infarction, or non-elective cardiovascular surgery for device related complications at 30 days. Secondary endpoints include the technical success of ring delivery, implantation, and delivery system retrieval, as well as changes in NYHA functional class, 6-Minute-Walk-Test, and safety at 6 months and 1 year.1,2

According to Sorajja, the learning curve for the AMEND ring is relatively simple – his team was reportedly fully trained and capable of installing the ring successfully after 1.5 days. The operation took 2 hours, which Sorajja remarked was particularly promising given the myriad complications which frequently occur in similar procedures.

Sorajja also discussed the ring’s potential as an add-on to existing therapies, allowing clinicians to elevate care by adding the annuloplasty on top of valve replacement or other MR treatment procedures.

“I think the most amazing thing about the AMEND technology is that it really is a platform for future transcatheter mitral surgeries,” Sorajja said. “When we think about the role of annuloplasty for stabilizing and treating patients with MR, it’s fundamental. And what’s important about technology like this is that it’s fundamental to all the other things we do in terms of repair and replacement, and it allows all those other technologies to still take place.”

Editor’s Note: Sorajja reports disclosures with 4C Medical, Abbott Structural, Edwards Lifesciences, EvolutionMed, Foldax, Haemonetics, and others.

References

1. Valcare Medical, Ltd. Valcare Medical Receives FDA Approval to Initiate Early Feasibility Study for its Novel AMEND Trans-Septal System. March 13, 2025. Accessed February 3, 2026. https://www.valcaremedical.com/valcare-medical-receives-fda-approval-to-initiate-early-feasibility-study-for-its-novel-amend-trans-septal-system/

2. Valcare Medical, Ltd. AMEND TS Early Feasibility Study. ClinicalTrials.gov Identifier: NCT06951672. Updated January 7, 2026. Accessed February 3, 2026. https://clinicaltrials.gov/study/NCT06951672?term=AREA%5BBasicSearch%5D(AREA%5BBasicSearch%5D(amend))&rank=1&checkSpell=