August 14, 2019
PreCardia Initiates VENUS-HF Early Feasibility Study in Patients With Acute Decompensated Heart Failure
August 15, 2019—PreCardia, Inc., which is developing technologies for the treatment of acute decompensated heart failure (ADHF), announced the enrollment of the first patient in the VENUS-HF Early Feasibility Study.
According to PreCardia, VENUS-HF is being conducted in the United States through an FDA investigational device exemption study. The study is evaluating the PreCardia system as a therapeutic approach for significantly congested patients with ADHF who are not diuresing adequately.
The company advised that the PreCardia system features a balloon catheter and pump controller designed to address ADHF via intermittent superior vena cava occlusion. By limiting venous return to the heart, PreCardia treats fundamental ADHF clinical hemodynamic targets. It is an investigational device and is limited by United States law to investigational use.
The first patient in the study was enrolled by Carey Kimmelstiel, MD, and Michael Kiernan, MD, at Tufts Medical Center in Boston, Massachusetts. Dr. Kimmelstiel is Director, Interventional Cardiology Center, and Dr. Kiernan is Director, Ventricular Assist Device Program, at Tufts. Navin Kapur, MD, who is Director of the Acute Circulatory Support Program at Tufts, serves as Chief Medical Advisor and Chair of PreCardia's Scientific Advisory Board.
In the company's announcement, Dr. Kapur commented, "The current ADHF treatment approaches are suboptimal in many patients and have not improved over the past 20 years, thus new treatment options are critical. We are excited to be pioneering a novel, minimally invasive transcatheter treatment approach that has the potential to greatly improve the lives of patients suffering from ADHF."