CVRx Wins Expanded EU Approval for Barostim Neo

European Union regulators have approved CVRx Inc.’s Barostim Neo carotid artery pulse stimulator for safe use with magnetic resonance imaging (MRI). The device is used for certain heart failure and drug resistant hypertension patients and is being investigated for wider clinical use.

The stimulator implanted around the lapel under the skin like a pacemaker, with single electric lead snaked up to the carotid artery where it activates baroreceptors that in turn regulate cardiac performance. It automatically monitors cardiac activity and adjusts on every beat, can be turned off when necessary, and is programmable for each patient’s unique needs.

“This approval has the potential to benefit many patients and their health care providers as MRI is critical in the diagnosis of serious conditions which can occur in the populations served by Barostim therapy. We are pleased to enable access to this diagnostic option for our current and future patients,” said Nadim Yared, CEO of CVRx.

CVRx has completed six-month follow-up in a 146 patient randomized, controlled clinical trial to demonstrate the performance of Barostim Therapy in patients suffering from chronic heart failure with advanced symptoms. Promising results from an earlier study demonstrating clinical improvement and reduced hospitalizations have been presented and published.

Five-year results of the 322-patient sham-controlled Rheos Hypertension Trial were presented at the American Society of Hypertension and the joint European and International Societies of Hypertension annual scientific conferences in May and June of 2014. The results showed a persistent and statistically significant reduction of systolic and diastolic blood pressure in excess of 32mmHg and 17mmHg, respectively, over the course of five years. In addition, the long term safety profile of the therapy proved to be excellent with very low rates of stroke, myocardial infarction and worsening of carotid stenosis in this population of patients with advanced hypertension.

Barostim therapy is included in the joint European Society of Hypertension and European Society of Cardiology guidelines for the treatment of resistant hypertension that were published in June, 2013.

Barostim Neo is a second generation device that uses CVRx-patented technology designed to trigger the body’s own natural blood flow regulation system to treat patients suffering from chronic heart failure and resistant hypertension. The system works by electrically activating the baroreceptors, the body’s natural sensors that regulate cardiovascular function.  By activating this afferent pathway, Barostim restores sympatho-vagal balance by reducing sympathetic activity and increasing parasympathetic activity.

Its benefits, according to the company, include:
 

• It can be turned on and off to demonstrate acute results;
• It can be adjusted to meet each patient’s individual therapy needs;
• It is a reversible treatment;
• It provides 100 percent compliance to treatment by continuously activating the baroreflex;
• It is compatible with and complementary to implantable cardio-defibrillators and cardiac resynchronization therapy; and
• It is now MR Conditional, or safe for use under specified conditions.
   

Based in Minneapolis, Minn., CVRx is a privately held company founded in 2001 that has developed an implantable technology to treat high blood pressure and heart failure.