FDA Approves IDE for Pulsar Vascular's PulseRider Aneurysm Neck Reconstruction Device

June 10, 2014—Pulsar Vascular announced that the US Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) for the PulseRider, the company’s minimally invasive aneurysm neck reconstruction device. The IDE allows Pulsar Vascular to begin a multicenter clinical trial in support of a humanitarian device exemption to evaluate the PulseRider for United States approval for wide-neck aneurysms at or near a bifurcation of the basilar tip or carotid terminus.

The clinical trial will be conducted at multiple clinical sites in the United States and is scheduled to begin in the third quarter of 2014. The PulseRider received European CE Mark approval in late 2013, and it has been in use in Europe since early 2014. The company plans to expand the European market while the United States clinical trial is underway.

The company stated that the PulseRider is designed to be fully retrievable and repositionable, and to address an unmet clinical need to treat complex-necked bifurcation aneurysms.

Adnan Siddiqui, MD, of the University of Buffalo in Buffalo, New York, commented in Pulsar Vascular’s press release, “The treatment of bifurcation aneurysms is truly an unmet need in endovascular therapies. I am excited by the positive response to the PulseRider in Europe, and as part of the United States clinical trial, I look forward to working with the company and the FDA to bring this novel, innovative technology into my everyday practice.”