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October 15, 2013
Pulsar Vascular's PulseRider Approved in Europe to Treat Cerebral Aneurysms
October 15, 2013—Pulsar Vascular (San Jose, CA) announced it received European CE Mark approval for the PulseRider, which is used to bridge the neck of cerebral aneurysms previously not amenable to endovascular therapy. The PulseRider is implanted via standard endovascular techniques, providing an alternative treatment option to open surgery. The company anticipates a European launch of the device this year.
Additionally, Pulsar Vascular will begin a small clinical study in the United States in early 2014 to provide further clinical evidence on the PulseRider's utility. This multicenter clinical trial will be conducted under a humanitarian device exemption from the US Food and Drug Administration in support of the regulator's approval of the PulseRider in the United States.
According to the company, the PulseRider is the first product in Pulsar Vascular's pipeline of devices using the company's therapeutic platform technology, which is intended to treat aneurysms in conjunction with embolic coils and/or flow diversion, thereby excluding aneurysms from the cerebral circulation.
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