V-Wave today announced it will present late-breaking data from its RELIEVE-HF pivotal trial at the American College of Cardiology’s (ACC) Annual Scientific Session & Expo taking place April 6-8 in Atlanta.
CAESAREA, Israel, March 28, 2024 /PRNewswire/ -- V-Wave today announced it will present late-breaking data from its RELIEVE-HF pivotal trial at the American College of Cardiology’s (ACC) Annual Scientific Session & Expo taking place April 6-8 in Atlanta. RELIEVE-HF is a randomized, double-blind, placebo-procedure-controlled, multicenter, multinational, pivotal trial of the V-Wave® Ventura® Interatrial Shunt in symptomatic patients with reduced (HFrEF) or preserved (HFpEF) left ventricular ejection fraction at high risk of heart failure (HF)-related events. “We’re pleased to present the RELIEVE-HF data at this year’s ACC meeting, as we continue to advance this important technology with the goal of bringing a much-needed treatment option to patients with advanced heart failure, a leading cause of death and hospitalization in the U.S. and worldwide,” said Neal Eigler, M.D., CEO of V-Wave. Summary of Presentation
About RELIEVE-HF The primary effectiveness endpoint was a composite of death, heart transplant/left ventricular assist device (LVAD) implantation, HF hospitalization, outpatient HF worsening, and quality of life. The primary safety endpoint was measured as device-related and procedure-related major adverse cardiovascular or neurological device-related events (MACNE) at 30 days. Patients were followed for the primary analysis for a minimum of 12 months and a maximum of 24 months (median of 22 months). The study was performed under the U.S. Food and Drug Administration’s Breakthrough Devices Program and enrolled patients at 101 hospitals in 11 countries, including in the U.S., Canada, Israel, Australia and New Zealand. About Heart Failure There are two types of HF. HFpEF is HF with preserved ejection fraction in which pressure builds up in the heart and lungs due to a stiffened left ventricle. This type of HF is largely associated with obesity and hypertension. In HFpEF, left ventricular ejection fraction (LVEF, a measure of the heart’s ability to pump oxygen-rich blood to the body) is >40. HFrEF is HF with reduced ejection fraction in which the left ventricle, the main pumping chamber of the heart, is weakened and usually enlarged and can’t effectively pump oxygen-rich blood to the body. In HFrEF, LVEF is <40. Treatments for HF, which include medications, lifestyle changes and medical devices, typically focus on improving survival, reducing the risk of heart failure hospitalizations, and providing symptom relief. Despite advances in HF therapy, premature death, recurrent hospitalizations and deteriorating quality of life remain a large burden to patients, their families and the U.S. healthcare system. About V-Wave Forward-Looking Statement CAUTION, the V-Wave® Ventura® Interatrial Shunt System is not available for sale in the United States or other countries. Limited by Federal (or United States) law to investigational use. Contact View original content:https://www.prnewswire.com/news-releases/v-wave-to-present-late-breaking-data-from-pivotal-relieve-hf-study-at-american-college-of-cardiology-annual-scientific-session--expo-302102187.html SOURCE V-Wave Ltd. |