The study has a unique design allowing initial analysis of safety and clinical efficacy for PMA submission after the first 250 patients have reached six months of follow-up, and then a second analysis after the entire cohort has reached 12 months of follow-up. ( Identifier: NCT04331769) The AccuCinch System has been studied in multiple clinical trials in the United States and the European Union, and is currently enrolling patients in the CORCINCH-HF Study, a prospective, randomized, open-label, multicenter, international, clinical safety and efficacy investigation, which is designed to enroll 400 patients at up to 80 centers worldwide. The AccuCinch System procedure is minimally invasive and is designed to augment the existing care cardiologists provide their heart failure patients.įor patients who have heart failure with reduced ejection fraction (HFrEF, or pumping efficiency), in whom the disease has progressed beyond the ability of medications and pacemakers to manage symptoms, the AccuCinch System may provide a new treatment option by filling the gap between medication or pacemaker therapy and more invasive treatments, including left ventricular assist devices (LVADs) or heart transplant. To address this challenge, we developed the AccuCinch ® Ventricular Restoration System, the only completely transcatheter device designed to treat the enlarged left ventricle, restore structure and function and bring relief to heart failure patients who remain symptomatic despite current guideline-directed medical care. It is clear that patients need new options to treat symptoms and improve their quality of life, and we are committed to developing new solutions that help change the course of this challenging condition. In fact, up to 50 percent of people who develop heart failure die within five years of diagnosis. Patients suffer from debilitating symptoms, exercise intolerance, poor quality of life, frequent hospitalization, and reduced life expectancy. Despite advances in heart failure treatment, high rehospitalization and mortality rates persist. Our team has a deep appreciation for the challenges faced by the estimated 26 million patients across the globe who are living with this chronic, progressive disease. Ancora Heart is dedicated to providing new treatment options for patients suffering from heart failure.
0 kommentar(er)
