US-based Pulsar Vascular has obtained CE Mark approval for its PulseRider device, designed to bridge the neck of cerebral aneurysms previously not amenable to endovascular therapy.
With this CE Mark approval, the company now has full distribution rights for the product within the EU.
This new device provides an alternative treatment option to open surgery as it is implanted through standard, minimally invasive, endovascular techniques.
Pulsar Vascular CEO Rob Abrams noted this achievement signifies validation of company’s scientifically advanced platform technology, which has received an enthusiastic reception from physicians both in the US and Europe.
"We look forward to making this pioneering technology available to European clinicians this year and beginning a small US clinical study early in 2014 to provide further clinical evidence of the utility of our product," Abrams added.
Pulsar Vascular will conduct a multi-center clinical trial in the US for PulseRider and this study will be a humanitarian device exemption performed under an investigational device exemption.
This study will support the US approval for the PulseRider.
PulseRider uses company’s therapeutic platform technology to exclude aneurysms from the cerebral circulation.