Clinical Trials Show Promise for Less-Invasive Therapy to Help With Mitral Valve Regurgitation

Recent outcomes from the MAVERIC clinical trial confirm earlier positive findings that MVRx’s ARTOTM System safely and effectively treats mitral valve regurgitation associated with congestive heart failure. The results, presented by leading cardiologists at EuroPCR, offer heart patients the promise of a less-invasive treatment for a life-threatening problem that affects more than 5 million people worldwide.
 
The ARTO System, a proprietary implantable device, is designed to improve heart failure symptoms by reducing mitral valve regurgitation, or the backward leakage of blood through the mitral valve, thereby increasing the forward flow of blood to the rest of the body. As a result, the heart functions more effectively and efficiently, leading to improved circulation, breathing, and exercise tolerance. The final Phase I and current 30-day outcomes of the MAVERIC trial, which now spans four continents and 15 centers of excellence, were presented last month at EuroPCR, the global forum for interventional cardiovascular medicine.
 
The three-year Phase I portion of the MAVERIC study included 11 patients enrolled at Pauls Stradins University Clinical Hospital, Riga, Latvia. The results, presented by Principal Investigator Andrejs Erglis M.D., Ph.D., demonstrate the ARTO System continues to provide a strong safety profile with 100 percent device success. Researchers found no instances of coronary artery compression, significantly reduced mitral valve regurgitation and significantly improved NYHA heart function classification, a measure of heart failure. Moreover, heart-failure hospitalization fell 64 percent in the two years after ARTO treatment compared with the two years prior. These results match those previously reported at earlier time points.
 
The current 30-day results from the multi-center MAVERIC trial were presented by Stephen Worthley, MB, BS, Ph.D., on behalf of the MAVERIC investigators. The report encompassed 45 patients inclusive of the 11 Phase I patients and represents a significant acceleration of enrollment beyond the single-center study. The 30-day results demonstrate that the ARTO System is safe with 100 percent device success; there were no deaths, strokes or myocardial infarctions (heart attack). At one month the findings also showed significantly reduced mitral valve regurgitation and significantly improved heart function. The 30-day results demonstrate that the safe and beneficial performance seen in the Phase I single-center study persists in a multi-center multi-operator setting.
 
“These successful results are an important and exciting milestone in finding a new therapy that can improve the lives of millions of people throughout the world,” said Robert Chang, president and CEO of MVRx. “The positive findings demonstrate the ARTO System’s potential to provide a very safe, minimally invasive, and effective therapy for these patients and a viable solution for an often stubborn problem faced by heart failure patients and their care providers.”
 
Based in San Mateo, Calif., MVRx is a company founded to develop the ARTO System, a proprietary, implantable device to treat Functional Mitral Regurgitation. The ARTO System for Transcatheter Annular Reduction Therapy (TART)—a simple, one-size technology to treat functional mitral regurgitation—improves the lives of heart failure patients in a safe, effective and easy-to-use solution. The multi-center, multinational MAVERIC clinical trial for the ARTO System is taking place on four continents and 15 centers of excellence in the United Kingdom, Italy, France, Latvia, South Africa, Australia, and the United States. The ARTO System is an investigational device throughout the world and is not available for sale in any jurisdiction.