March 5, 2020
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
V-Wave Ltd., a privately held medical device company developing novel implantable devices for the treatment of Heart Failure (HF), today announced that its Ventura™ Interatrial Shunt System received CE Mark and is now approved to be marketed for use in the European Union.
“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 and renowned heart failure cardiologist, William T. Abraham, MD. “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.”
The Ventura Interatrial Shunt is being evaluated in a global, randomized, controlled, double-blinded, 500 patient U.S. Food and Drug Administration (FDA) IDE pivotal trial called RELIEVE-HF, which is designed to demonstrate safety and effectiveness of shunt therapy in reducing HF morbidity and mortality and improving functional status. The study is enrolling advanced HF patients with preserved or reduced left ventricular ejection fraction who remain symptomatic despite the use of guideline-directed medical and device therapies. Approximately 100 of the top hospitals in North America, Europe and Israel are or will be participating.
“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,” said V-Wave CEO Neal Eigler, MD. “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.”
About V-Wave Ltd.
V-Wave is a privately held medical device company with offices in Israel and the U.S. In addition to developing interatrial shunt device technologies for the treatment of heart failure, V-Wave is exploring the use of such technologies for the treatment of Pulmonary Arterial Hypertension in an FDA IDE Early Feasibility Study. For more information, please visit www.vwavemedical.com
This press release contains certain forward-looking statements that involve risks and uncertainties, including statements related to clinical development and potential regulatory approval of V-Wave’s products. All forward-looking statements and other information included in this press release are based on information available to V-Wave as of the date hereof, and the Company assumes no obligation to update any such forward-looking statements or information. The company’s actual results could differ materially from those described in the company’s forward-looking statements.
CAUTION: THE VENTURA™ INTERATRIAL SHUNT SYSTEM IS UNDER CLINICAL INVESTIGATION.