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October 18, 2015
Enrollment Completed for Pulsar Vascular's US Clinical Trial for PulseRider Intracranial Aneurysm Device
October 19, 2015—Pulsar Vascular announced that the target enrollment has been reached in the clinical trial for the company’s PulseRider device, which is designed treat complex aneurysms of the brain. This multicenter study was conducted at 10 centers of excellence nationwide under an investigational device exemption from the US Food and Drug Administration (FDA). The company expects to submit the study’s finding to the FDA in early 2016.
The study was led by Principal Investigator Alejandro Spiotta, MD, who is Assistant Professor of Neurosurgery and Interventional Neuroradiology at the Medical University of South Carolina, in Charleston, South Carolina.
Pulsar Vascular advised that the PulseRider is not available for sale in the United States and is limited by United States law to investigational use only. In October 2013, the company announced European CE Mark approval for the PulseRider to bridge the neck of cerebral aneurysms previously not amenable to endovascular therapy.
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