CVRx has received the European CE Mark of approval for its second-generation implantable anti-hypertensive barostimulation device, the Barostim neo. It is the successor of their RHEOS baroreflex stimulation device, which we have covered several times before. Compared to its predecessor, it features a new unilateral 1mm electrode and a smaller, more advanced stimulator. The stimulator is implanted underneath the pectoralis muscle, with a subfascial lead running to the carotid sinus. The system works by electrically activating the baroreceptors located on the carotid artery. This makes the body’s own blood pressure regulation mechanisms decrease blood pressure by reduction of the sympathetic tone, leading to a peripheral vasodilation, lower heart rate and increased fluid excretion by the kidneys.
The device is approved for hypertension resistant to medical therapy only, meaning for now it is limited to a relatively small, well-defined patient group. Results with the RHEOS device have been positive, with reductions in blood pressure in the order of 20/10 mmHg on top of maximal medical therapy. In addition there are indications that the device might be effective in treating certain forms of heart failure. The latest results with the Barostim neo will be presented on August 30 at the European Society of Cardiology (ESC) Congress 2011.
Flashbacks: Positive Results from Trial of Rheos Baroreflex Hypertension Therapy; RHEOS Device for Blood Pressure Control Undergoing New Trial; Rheos System for Hypertension Tested in New Clinical Trial