CVRx, Inc., a private medical device company, announced the first patient enrolled in the Barostim HOPE4HF clinical trial. The study is evaluating the effectiveness and safety of CVRx's Barostim neo in heart failure patients. Dr. Richard Abben , Director of Cardiac Intervention, with the Cardiovascular Institute of the South, in Houma, Louisiana is the Principal Investigator for the center. The prospective, randomized and controlled study will enroll 60 patients in multiple clinical centers throughout the United States.
According to Dr. Abben, "Getting this trial under way is great news for the many individuals who desperately need options beyond traditional drug therapy to manage their heart failure. Barostim therapy has been studied in over 500 patients, with promising results. The second generation Barostim neo being used in this study is small and easy to place in a short procedure. We anticipate positive results from this new system."
"The HOPE4HF trial is an important step toward making Barostim Therapy™ available as a treatment for heart failure patients," said Nadim Yared , president and CEO of CVRx. "Barostim neo has had a strong safety profile and excellent clinical results in European studies. We anticipate these positive outcomes to continue in this study. Heart failure affects millions of people, which provides CVRx the opportunity to significantly expand our patient population and market reach." Other HOPE4HF clinical centers have started to enroll patients into the trial. The Aspirus Heart and Vascular Institute (Wassau, Wisconsin) led by Dr. German Larrain , randomized the second, third, fourth and fifth patients in the study.
Early Positive Heart Failure Results Presented at American Heart Association Scientific Sessions
Barostim neo data on heart failure patients were presented in two sessions at the American Heart Association (AHA) Scientific Sessions 2012. Professor Edoardo Gronda , IRCCS MultiMedica Milano, Italy, and Professor Jochen Muller-Ehmsen , University of Cologne, Germany, shared study results showing significant improvements in quality of life, functional capacity, biochemical markers and NYHA Class, and a reduction in sympathetic tone using Barostim neo.
"These early results of Barostim Therapy in heart failure patients who have a reduced ejection fraction and who are already on optimal medical treatment and, in some cases, already receiving cardiac resynchronization therapy, are very promising. This study will provide further insight into the magnitude of the long-term benefits of the therapy in this patient population," said Dr. Michael Zile , Charles Ezra Daniel Professor of Medicine, at the Medical University of South Carolina. Dr. Zile is on the Executive Steering Committee for this study.