Banner – University Medical Center Phoenix has quietly notched a national first, performing the initial U.S. implantation of Valcare Medical’s AMEND transcatheter annuloplasty ring to repair a leaky mitral valve on a beating heart. Led by interventional cardiologist Dr. Paul Sorajja, the team skipped traditional open-heart surgery. Instead, it used a catheter-based approach that hospital leaders say could mean shorter hospital stays, faster recovery, and only tiny scars instead of a full chest incision.
According to the hospital, the heart team guided a catheter through a blood vessel, crossed the septum between the heart’s chambers, and deployed a D-shaped annuloplasty ring to tighten the mitral valve and reduce regurgitation. The case is being billed as the first successful U.S. use of the device, announced by the hospital last Monday and then picked up by local media later in the week, as outlined by KTAR.
How the AMEND Ring Works
The AMEND device is a semi-rigid, D-shaped annuloplasty ring designed to mimic the support rings that surgeons typically sew into the mitral annulus during open-heart repair, only this one can be delivered through a catheter passed across the septum. Industry reporting notes that the ring may be implanted on its own or paired with edge-to-edge or chordal repair techniques, reshaping the valve annulus while keeping future treatment options on the table. Valcare previously reported a first-in-human transseptal implant in Toronto in 2021, according to Cardiovascular Business.
Regulatory Status and the Clinical Study
The AMEND transseptal system moved into the U.S. early-feasibility pathway after the FDA granted an investigational device exemption in March 2025. The trial record lists Banner – University Medical Center Phoenix, with Dr. Paul Sorajja as principal investigator, as one of the enrolling U.S. centers. The Early Feasibility Study is set to include a limited number of patients at investigational sites to assess safety, technical success and short-term outcomes, as registered at ClinicalTrials.gov.
What It Means for Patients
Banner and the physicians involved say this catheter-based option could offer patients less pain, minimal scarring and a much quicker return to daily life than standard open-heart mitral repair, with some individuals potentially heading home the day after the procedure. “This new procedure offers a minimally invasive alternative that could help patients get back to living their lives with less pain, faster recovery, and better outcomes,” Dr. Sorajja said in a statement from Banner Health…