CircuLite won CE Mark approval in the European Union for its Synergy heart pump; EuroZone regulators also OK NeuroSigma's Monarch trigeminal nerve stimulation device for epilepsy and depression.
The European Union granted CE Mark approval to a pair of medical device companies, CircuLite and NeuroSigma, for their technologies designed to treat heart failure, epilepsy and depression.
Middle Brook, N.J. and Aachen, Germany-based CircuLite said it landed its EuroZone nod for its Synergy heart pump, designed to treat ambulatory heart disease patients. The battery-sized device is inserted into a subcutaneous pocket under the right collarbone, unlike the left ventricular assist devices it competes with, which require open heart surgery. Thoratec (NSDQ:THOR) and HeartWare International (NSDQ:HTWR) are the leading LVAD manufacturers.
"With CE Marking in place, we will begin a controlled launch of this ground-breaking advancement in select European markets," president and CEO Paul Southworth said in prepared remarks.