Neurovascular technology company Pulsar Vascular has received European CE Mark approval for its lead product, the PulseRider®. The company says its device is designed to treat brain aneurysms in conjunction with embolic coils or flow diversion devices.
Many neurological aneurysms can be identified before they rupture, such are the advances in imaging technology that have taken place over recent years. This opens up a new market for prospective brain aneurysm treatment which is estimated to extend to over 200,000 cases globally in 2015.
Pulsar Vascular tells us it focuses on therapeutic platforms that leverage the classic design of the ancient arch, to treat aneurysms in conjunction with embolic coils and/or flow diversion. The PulseRider is the first in a robust pipeline of proprietary devices utilizing this platform technology to exclude aneurysms from the cerebral circulation.
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.
With its CE mark in the bag the company is expecting to launch the device in Europe this year and is about to undertake a US clinical study under Humanitarian Device Exemption (HDE) rules, done under an Investigational Device Exemption (IDE). Pulsar hopes this multi-center clinical trial will support the US approval of the PulseRider.
Rob Abrams, the 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 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.”
Source: Pulsar Vascular, Inc., PR Newswire