On 29 April, CVRx announced that it has enrolled the first patient in the Barostim HOPE4HF clinical trial. The study is evaluating the effectiveness and safety of the Barostim neo device in heart failure patients.
The prospective, randomised, controlled study will enrol 60 patients in multiple clinical centres throughout the United States.
Richard Abben, director of Cardiac Intervention, Cardiovascular Institute of the South, in Houma, USA, and principal investigator for the centre, said: “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 centres have started to enrol patients into the trial. The Aspirus Heart and Vascular Institute (Wassau, USA) led by German Larrain, randomised the second, third, fourth and fifth patients in the study.
About Barostim neo
Barostim neo is a second generation device that uses CVRx-patented technology that is designed to trigger the body’s own natural blood flow regulation system to treat heart failure. The system works by electrically activating the baroreceptors, the body’s natural blood pressure sensors that regulate cardiovascular function. These baroreceptors are located on the carotid artery. When activated by Barostim neo, signals are sent through neural pathways to the brain, which responds by telling the:
- Arteries to relax, making it easier for blood to flow through the body and reducing cardiac exertion;
- Heart to slow down, allowing more time for the organ to fill with blood; and
- Kidneys to reduce fluid in the body, lowering both excessive blood pressure and workload on the heart.
This unique, patented technology has the potential to improve quality of life and reduce health risks associated with heart failure, including heart and kidney disease, stroke and death. Other key potential benefits of Barostim neo include that it:
- Can be adjusted to meet each patient’s individual therapy needs;
- Is a reversible treatment; and
- Provides 100% compliance to treatment, by automatically and continuously activating the baroreflex.