V-Wave announced today that its Ventura interatrial shunt system has received the CE Mark.
The Caesarea, Israel-based company’s minimally invasive, implanted interatrial shunt is being evaluated in a global, randomized, controlled, double-blinded, 500-patient pivotal IDE trial called RELIEVE-HF. The study is enrolling advanced heart failure patients with preserved or reduced left ventricular ejection fraction who remain symptomatic despite the use of guideline-directed medical and device therapies.
“More than 26 million people suffer from chronic heart failure worldwide, and HF remains a leading driver of disability and acute hospitalization, particularly in the growing elderly population,” noted V-Wave chief medical officer Dr. William T. Abraham in a news release. “Despite decades of advances, heart failure patients continue to progressively deteriorate, enduring disabling symptoms, having a poor quality of life, diminished exercise tolerance and a markedly reduced life expectancy. The minimally invasive implanted Ventura interatrial shunt relieves excessive pressure in the left side of the heart, thereby reducing the build-up of fluid in the lungs, which is the most common reason for worsening HF symptoms, exercise limitation, and HF hospitalizations.”
“CE mark for the Ventura interatrial shunt system is a significant milestone for V-Wave, as it recognizes that this therapeutic product conforms to the standards of the European Medical Device Directive,” added V-Wave CEO DR. Neal Eigler. “Along with the FDA breakthrough device designations we received last year, CE Marking will help accelerate the introduction of our potentially impactful clinical treatment to the millions of patients suffering from heart failure.”
V-Wave won those FDA breakthrough designations in August and September 2019.