PHOENIX (Oct. 27, 2025) – Paul Sorajja, MD, a nationally recognized leader in interventional cardiology and valve science with Banner – University Medical Center Phoenix, has helped bring a life-changing treatment to thousands of patients across the country. His pioneering work led to the first FDA approval of a device that can replace damaged heart valves in patients who were previously considered too sick for surgery.
Dr. Sorajja made medical history in 2016 when he became the first doctor in the world to use a specialized mitral device, Tendyne, to treat a patient with severe mitral annular calcification (MAC) – a condition where dangerous calcium buildup around the heart valve makes traditional surgery life-threatening.
"We had patients coming to us who were told nothing could be done," said Dr. Sorajja. "These were patients whose heart valves were failing, but they were too high-risk for open-heart surgery."
Now, the newly FDA-approved treatment offers hope to patients with MAC, a condition that affects up to 30% of elderly Americans. Previously, these patients faced a devastating choice: risk a dangerous surgery that many wouldn't survive or live with worsening heart failure.
The Tendyne device changes that equation entirely. Instead of opening the chest, doctors can now replace the damaged valve through a small incision between the ribs. Patients typically go home within a week and experience dramatic improvements in their ability to breathe and perform daily activities. All patients suffering from MAC are eligible for this new procedure.
Dr. Sorajja led a nationwide study that followed 103 patients who received the treatment. The results were remarkable: Nearly nine out of 10 patients saw significant improvement in their heart failure symptoms and reported major improvements in their quality of life and ability to be active. The procedure was also successful in eliminating dangerous valve leakage in virtually all patients.
"We're seeing patients who couldn't walk to their mailbox now able to enjoy time with their grandchildren again," Dr. Sorajja explained.
With the device now FDA-approved and commercially available, Banner Health continues to be a leader in this advanced treatment. The medical system has built expertise in complex heart valve procedures and serves as a training center for other hospitals learning the technique.
The approval represents the culmination of nearly a decade of research and development. Dr. Sorajja's early work helped prove the treatment was both safe and effective, paving the way for thousands of patients nationwide to access this life-changing therapy. Banner Health physicians, including Dr. Rizik, interventional cardiologist at Banner – University Medicine Cardiology Scottsdale, and Dr. Ken Fang, cardiovascular surgeon at Banner – University Medical Center Phoenix, played integral roles in the clinical research that supported the Tendyne FDA approval process.
"This is what medicine is all about – taking something that seemed impossible and making it possible," said Dr. Sorajja. "We're giving patients and families hope where there wasn't any before."
Banner Health is one of the largest nonprofit health care systems in the country and a leader in provider-sponsored health insurance serving 3.5 million people annually across six states. With 33 hospitals and more than 450 additional care sites, Banner’s array of services includes a health insurance division, employed physician groups, outpatient surgery centers, urgent care locations, home care and hospice services, retail pharmacies, stand-alone imaging centers, physical therapy and rehabilitation, behavioral health services, a research division and a nursing registry. To make health care easier, 100% of Banner-employed doctors are available for virtual visits and patients may also reserve spots at Banner Urgent Care locations and can book appointments online with many Banner-employed doctors. Headquartered in Arizona, Banner Health also has locations in California, Colorado, Nebraska, Nevada and Wyoming. For more information, visit bannerhealth.com.
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