Minneapolis – July 2, 2012 – CVRx, Inc., a private medical device company, has launched today a European post-market hypertension registry to track performance outcomes and physician experience using the company’s Barostim neo device for hypertension. The registry is expected to enroll up to 500 patients.
“Growing numbers of resistant hypertension patients in Europe are receiving treatment with the Barostim neo,” said Nadim Yared, president and chief executive officer of CVRx. “Establishing the registry is an important means of gathering information about our product’s long-term performance when deployed broadly.”
The registry will collect data for ongoing monitoring of Barostim™ therapy. It will be available for all resistant hypertensive patients treated with the neo™ device.
“The Barostim neo is a unique technology for treating hypertension. With an expanding population of resistant hypertension, we clearly need new, effective treatments,” said Professor Horst Sievert, CVC Frankfurt. “We are excited about the positive outcomes and safety profile of the device to date. Collecting post-market patient data through the registry will help us monitor its performance as more patients receive treatment.”
In addition, CVRx is establishing centers of excellence at selected institutions in primary markets, to help ensure the best patient outcomes. CVRx is identifying and will begin training qualified centers interested in becoming a center of excellence.
CVRx received CE Mark approval for the Barostim neo device, and it is currently available in Germany, Italy, The Netherlands, Switzerland and Austria.
Barostim neo Therapy
The Barostim neo uses CVRx-patented technology that is designed to trigger the body’s own natural blood flow regulation system to treat hypertension and 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 the 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.
The Barostim neo device can be adjusted to meet each patient’s individual needs, making it the only personalized device therapy for hypertension currently available in Europe.
In Europe, hypertension affects an estimated 40 percent of adults, or 154 million people.1 The incidence of hypertension is higher in Europe than the United States due to an older population and higher smoking rates. Worldwide, hypertension is estimated to cause one in every eight deaths.2 It is a major risk factor for cardiovascular disease, morbidity and mortality. Twenty-five percent of people with hypertension cannot adequately control their hypertension with medications and lifestyle modifications.3,4 It is a disease that needs new treatment solutions.
1.Estimated based on data from Dymedex Consulting
2.Heart Disease and Stroke Statistics. American Heart Association – 2011 Update.
3.Prospective Studies Collaboration. Age-specific relevance of usual blood pressure to vascular mortality: a meta-analysis of individual data for one million adults in 61 prospective studies. Lancet 2002;360:1903-1913.
4.Chobian AV. JAMA 2003;289:2560-2572.