Aptus Endosystems won CE Mark approval in the European Union for its next-generation thoracic-length delivery system for the Heli-FX device aortic securement device.
The newly green-lighted system includes a longer delivery device and additional features to treat thoracic aortic aneurysms. According to company estimates, this patient population in Europe includes 5,000 newly diagnosed patients and 12,000 patient treated overall each year.
"The CE clearance of the Heli-FX system designed for thoracic aortic aneurysms is a major milestone for the Aptus team and our European physician partners," Aptus Endosystems CEO James Reinstein said in prepared remarks.
The original Heli-FX device was cleared for sale in Europe in May 2011. The Sunnyvale, Calif.-based company landed FDA clearance for the thoracic-length Heli-FX device in September 2012.