The approval also allows InspireMD to add-on manufacturing facilities for the device to enable more efficient work flow, the Boston-based company said.
“We are pleased to receive Dekra certification for our enhanced CGuard delivery catheter, used when delivering the CGuard EPS into the carotid anatomy, supporting a more profitable and fluid scaling of our manufacturing operations. Our CGuard system continues to be well received during our initial product launch in key markets around Europe and our recent positive 12 month Carenet data should bolster our commercial efforts going forward,” CEO Alan Milinazzo said in prepared remarks.
InspireMD’s Carenet trial reported no strokes or stroke related deaths with the CGuard stent after 12 months, and duplex ultrasound analysis reported no changes in the in-stent velocities between 6 and 12 months, the company said.
The company won the approval through Dekra medical device certification, which includes CE mark approval and ISO 13485 quality management system approval for testing devices for sale in the EU.
In October, InspireMD said it pulled the trigger on a reverse 10-to-1 stock split with shareholders receiving 1 share of common stock for each 10 they own.
The reverse split went into effect October 1 for the Boston-based stent maker, according to a press release. In response, Inspire shares fell 11.8% to $1.45 in mid-day trading.
The split reduced the amount of authorized shares from 125 million to 50 million, the company said.