On 2 July, CVRx launched 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 enrol 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 centres 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.