Pulsar Vascular announced that it has received European CE mark approval for Pulserider. This unique implant is used to bridge the neck of cerebral aneurysms previously not amenable to endovascular therapy. This new device is implanted via standard, minimally invasive, endovascular techniques thus providing an alternative treatment option to open surgery.
The CE mark allows the company full distribution rights within the European Union and a European launch of the device is to follow. Rob Abrams, CEO of Pulsar Vascular describes this as a major milestone for the company stating, “This achievement signifies validation of our scientifically advanced platform technology, which has received an enthusiastic reception from physicians both in the USA 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.”
The US clinical study will be a Humanitarian Device Exemption (HDE) done under an Investigational Device Exemption (IDE). This will be a multicentre clinical trial to support the US approval of the PulseRider.
Pulsar Vascular is focused on therapeutic platforms that leverage the classic design of the ancient arch, to treat aneurysms in conjunction with embolic coils and/or flow diversion. Pulserider is the first in a robust pipeline of proprietary devices utilising this platform technology to exclude aneurysms from the cerebral circulation, a press release from the company says.