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.
CircuLite raised $30 million in a Series D round late last year to support the European launch for Synergy and landed a nearly $1 million grant early this year from the Cardiovascular Medical Research & Education Fund.
Los Angeles-based NeuroSigma said its CE Mark covers indications for depression and epilepsy for its Monarch trigeminal nerve stimulation device, which uses a pulse generator and disposable external patches to deliver therapy while patients sleep.
“We are excited to begin the rollout of our commercialization strategy for patients suffering from epilepsy and depression. Simultaneously, we will seek to obtain approvals in other parts of the world. In the United States, we will be submitting a request to the FDA for an Investigational Device Exemption (IDE) to commence a multi-center eTNS pivotal trial in epilepsy. Over thirty major centers in the US and Europe have expressed interest in being part of this pivotal trial,” president & CEO Leon Ekchian said in prepared remarks.