Paul Sorajja, MD, is the associate director of the Banner – University Medicine Heart Institute and professor of medicine at the University of Arizona. 

Paul Sorajja, MD

New AMEND MR Ring Successfully Implanted for the First Time in the US

Valcare Medical, Ltd.’s AMEND annuloplasty ring, a closed D-shaped semi-rigid device built to mimic the surgical gold standard of 

treatment, has been successfully implanted in a patient for the first time in the US.

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.

 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 

. “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.

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.

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.

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/

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=

Videos

Sorajja describes his team’s operation to implant the ring via a novel trans-septal system, effectively avoiding the need to stop the heart in MR treatment.

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

SUMMIT-MAC: Tendyne System Improves Survival in MAC, With Paul Sorajja, MD

Patients with severe mitral annular calcification (MAC) who underwent transcatheter mitral valve replacement with Abbott’s Tendyne implant exhibited substantially reduced all-cause mortality and 

 hospitalization, based on the SUMMIT-MAC interventional trial.

The Tendyne system includes multiple sizes to accommodate for a range of patient anatomies. The valve is self-expanding, delivered through an incision in the chest and advanced into the heart to replace the mitral valve. Tendyne is also totally repositionable and retrievable during implantation.

 spoke with Paul Sorajja, MD, associate director of the Banner – University Medicine Heart Institute and professor of medicine at the University of Arizona, to discuss the results of SUMMIT-MAC and how the Tendyne system may revolutionize this otherwise difficult-to-treat disease.

“As the first of its kind, Tendyne is quite novel, because up until now we had no knowledge of what a dedicated TMVR device would look like in terms of outcomes for these patients,” Sorajja told 

. “The results exceeded expectations; we had excellent technical success.”

SUMMIT-MAC is the first prospective clinical trial designed to assess Tendyne’s efficacy in patients with severe MAC. All included patients had severe MAC with significant mitral valve dysfunction and were at high surgical risk. An echocardiography laboratory performed independent assessments of mitral disease, and adverse events were judged by an independent clinical events committee. The study’s primary endpoint was freedom from all-cause mortality and heart failure hospitalization at 12 months post-procedure.

A total of 103 patients were ultimately included, with a mean age of 78 +/- 6.5 years. All patients underwent treatment with Tendyne, as either mitral regurgitation or stenosis was present in nearly every patient at baseline. Technical success from the implant was achieved in 94.2%. Investigators noted a 30-day mortality of 6.8%.

The primary endpoint of freedom from all-cause mortality and heart failure hospitalization was met, which reached 60.4% at 12 months (performance goal: 43%; 

 = .0002). Heart failure symptoms (NYHA Class I/II, 30.6% vs 87.5%, paired baseline vs 12 months; 

 <.0001) and quality of life (mean paired increase in the Kansas City Cardiomyopathy Questionnaire overall summary, 18.7 +/- 24.4 points; 

Ultimately, this trial was a core component in the 

 approval of Tendyne, announced by Abbott in May 2025.

“The key next steps are to ensure that the commercial outcomes match what we observed in the clinical trial, which means greater attention to even more operator education, patient selection, and being very meticulous about how the procedure is done,” Sorajja said. “I think as long as we keep an eye on those things, I think this will have a really strong role in our patients with severe MAC.”

Sorajja, P, Thourani, V, Rogers, J. et al. Transcatheter Mitral Valve Replacement for Severe Mitral Annular Calcification: Primary Outcomes from the SUMMIT-MAC Study. JACC. null2025, 0 (0). 

https://doi.org/10.1016/j.jacc.2025.10.025

Kong C. Abbott Receives FDA Approval for Tendyne, First-Of-Its-Kind Device to Replace the Mitral Valve Without Open-Heart Surgery. Abbott. May 27, 2025. Accessed December 1, 2025. 

https://abbott.mediaroom.com/2025-05-27-Abbott-Receives-FDA-Approval-for-Tendyne-TM-,-First-of-Its-Kind-Device-to-Replace-the-Mitral-Valve-Without-Open-Heart-Surgery

Sorajja discusses the results of this groundbreaking trial investigating a new implant for patients with severe mitral annular calcification.

Paul Sorajja, MD

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