MVRx touts safety, efficacy in Arto device clinical trial
MVRx released outcomes from the Maveric clinical trial of its Arto implantable device, touting its safety and efficacy in treating mitral valve regurgitation associated with congestive heart failure.
The Arto system is designed to improve heart failure symptoms by reducing mitral valve regurgitation to increase forward flow of blood to the rest of the body, the San Mateo, Calif.-based company said.
Results from the 3-year Phase I portion of the study included 11 patients, and results indicated a 100% device success rate with no instances of coronary artery compression.
Data also indicated significantly reduced mitral valve regurgitation and improved NYHA heart function classifications. Heart failure hospitalizations fell 64% in the 2 years after treatment compared with the 2 years prior, the company said.
Data from a larger patient subset of the trial at 30 days indicated a 100% device success rate and no deaths, strokes or myocardial infarction. The 1-month data also indicated significantly reduced mitral valve regurgitation and slightly improved heart function, the company said.
“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. 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,” prez & CEO Robert Chang said in a prepared statement.