CVRx said its Barostim neo system was granted expanded CE Mark approval in the European Union for use with MRI procedures.
Barostim neo is used to help regulate blood flow in patients suffering from heart failure or drug-resistant hypertension. The system uses a small pulse generator, which is implanted under the collarbone, to activate the body’s blood-pressure sensors, or baroreceptors. The device can also be used with implantable cardio-defibrillators and cardiac resynchronization therapy.
CVRx said that the expanded approval allows for the system to be used during MRIs under certain conditions.
In September, European regulators awarded expanded approval for Barostim neo for the treatment of heart failure. The product first received CE Mark clearance in 2011 for the treatment of high blood pressure.
CEO Nadim Yared told MassDevice.com in September that the Barostim neo device is designed to influence both the sympathetic and parasympathetic systems, reducing sympathetic activity and increasing parasympathetic activity.
“It’s actually pretty straightforward. Heart failure as a disease is most often due to the fact that the sympathetic signal from the brain to the organ is elevated and the vagus tone is depressed. It’s the same with hypertension, basically. We have a unique platform where we are not targeting either the sympathetic system alone or the parasympathetic system alone,” Yared told us.
CVRx added a $15 million loan from Silicon Valley Bank to the $251 million it’s raised so far. CVRx is negotiating with the FDA on the parameters for clinical trials in the U.S. ahead of pre-market approval bids for both the heart failure indication and the hypertension indication, Yared said (the Minneapolis-based company won CE Mark approval for the treatment of hypertension in August 2011).
