A La Jolla cardiologist has quietly made local medical history, becoming the first doctor in San Diego County to implant the newly FDA‑approved Trilogy transcatheter heart valve. The minimally invasive procedure offers a new option for people with severe aortic regurgitation who are considered too high‑risk for open‑heart surgery.
Curtiss Stinis performed the outpatient procedure at Scripps Memorial Hospital La Jolla on April 21. The patient reported feeling better right away and went home the next morning, a quick turnaround that underscores how different this is from traditional surgery. The implant follows national trial data and federal regulatory sign‑off that cleared the device for commercial use.
How the Trilogy valve works
The Trilogy system is built around three radiopaque locators that grasp the native valve leaflets. That design lets the device anchor securely even when there is little or no calcification, a long‑standing limitation that kept other TAVR implants from reliably treating pure aortic regurgitation. The locator mechanism also helps the valve seal tightly and preserve coronary access, while allowing cardiologists to deliver the implant transfemorally through the femoral artery.
According to JenaValve, the company plans to begin launch activity at participating clinical study sites following FDA approval.
What the trial found
The pivotal ALIGN‑AR trial that supported approval enrolled nearly 700 patients across the country and met its prespecified safety and efficacy endpoints. Investigators reported high technical success along with low early stroke and mortality rates.
Results published in The Lancet showed that only three participants had significant residual valve leakage and that patients saw durable gains in function and quality of life for up to two years after treatment. Those outcomes were central to regulators' decision to authorize commercial use.
Scripps' role and one patient's recovery
Scripps Clinic cardiologists and 22 of their patients took part in the ALIGN‑AR study, and Curtiss Stinis served as the site's lead investigator, according to Scripps Health. That work set the stage for the first commercial‑use implant in the county.
One trial participant, 65‑year‑old Escondido resident John Rufo, received his outpatient implant in May 2024 and told local reporters he felt better the next day, as reported by 10News. Both the health system and local coverage note that most patients are typically discharged the following morning.
FDA clearance, coverage and monitoring
The FDA granted premarket approval for the Trilogy on March 17, 2026, authorizing it for symptomatic, severe native aortic regurgitation in patients deemed by a heart team to be at high or greater surgical risk. The agency's PMA letter also requires post‑approval studies and places training and distribution restrictions on the device, according to the FDA.
JenaValve has said the Trilogy will be covered by Medicare and most private insurers as rollout begins at participating centers. The PMA calls for long‑term follow‑up and registry‑based surveillance to track real‑world outcomes and better capture underrepresented populations.
What clinicians say and what's next
Cardiologists say the Trilogy valve fills a long‑standing gap for patients with pure aortic regurgitation, a group that often had limited options, but they also emphasize that broader post‑approval data will be needed to define the device's role across different risk profiles.
The American College of Cardiology has noted that the ALIGN‑AR findings are encouraging while underscoring the importance of registry monitoring as the therapy reaches more patients. Scripps has said investigators will continue to enroll and follow patients as part of post‑approval studies to better understand who benefits most.
For San Diego residents who were previously told surgery was their only way forward, the Trilogy now offers a less invasive lifeline. Local cardiology teams say they will keep screening eligible patients and tracking outcomes as the device becomes more widely available across the region.
