MORGANTOWN, W.Va. – Doctors at the WVU Rockefeller Neuroscience Institute have treated the first patients in the world in a clinical trial to collect real-world, post-marketing data on the use of a new device for the endovascular treatment of cerebral aneurysms.
It has been 25 years since the U.S. Food and Drug Administration has allowed an investigational device to undergo a U.S. clinical trial prior to its approval outside the U.S.
“It has taken a lot of work over the last two years to get to this point,” Ansaar Rai, M.D., neurointerventional radiologist, professor of Neuroradiology and Neurosurgery at the WVU Rockefeller Neuroscience Institute, and national principal investigator of the trial, said. “This new pathway will allow U.S. physicians to be at par with or ahead of their colleagues outside the U.S.”
Dr. Rai and his team at the WVU Rockefeller Neuroscience Institute are among five other sites to participate in this initial feasibility and safety study. Based on the results, the FDA may grant permission to move forward with a larger study of the device.
“The opportunity to test this device in the U.S. is novel,” Rai said. “When people come here, they can know that they are able to get the same care as they would anywhere else in the world and may have access to therapies not available anywhere else. To be chosen to conduct these high-end, innovative trials demonstrates that we have a base of excellence and a tradition of leadership in the field.”