Pulsar Vascular Gets Green Light for Clinical Trial of PulseRider Aneurysm Treatment

Neurovascular devicemaker Pulsar Vascular will begin a multicenter clinical trial its PulseRide aneurysm neck reconstruction device during the 2014 third, following the receipt of an FDA investigational device exemption.

The trial — to evaluate the device as a treatment for wide neck aneurysms at or near a bifurcation of the basilar tip or carotid terminus — will support an application for humanitarian device exemption, the San Jose, Calif., company said Tuesday.

There are currently no FDA-approved devices for this indication, Pulsar Vascular said.

The minimally invasive PulseRider is designed to be fully retrievable and repositionable. It received a CE Mark in October 2013 and has been available for use in Europe since early 2014.

Pulsar Vascular CEO Rob Abrams said that the device’s IDE validates the company’s platform technology and represents a significant company milestone. The devicemaker expects to expand the European market for the device while U.S. trials are underway. — Kellen Owings

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