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01.09.20

FDA Grants Premarket Approval for New Flow Diverter For Brain Aneurysms

  • KEYWORDS:
  • Aneurysm
  • Stroke

The Food and Drug Administration has granted premarket approval (PMA) for a flow diverter (Flow Redirection Endoluminal Device [FRED] device; MicroVention, Aliso Viejo, California) for the treatment of brain aneurysms. The device is the first flow diverter in the US to use a self-expanding braided nitinol mesh to help redirect blood flow and promote aneurysm occlusion. The interwoven nitinol design of the device allows for smooth delivery to the target aneurysm, as well as reliable opening and vessel wall apposition, resulting in high treatment durability.

The device has been CE marked in Europe, indicating conformity with health, safety, and environmental protection standards, since 2013, safely used in nearly 20,000 procedures, and published in numerous clinical studies around the world. The FRED device pivotal study adds new evidence to the large existing body of global clinical data, further demonstrating the safety and effectiveness of the device. 

"The FRED device represents a step forward in flow diversion technology with the inclusion of the lowest profile delivery platform in the US. This advancement will allow physicians to more easily access and treat wide-necked or fusiform aneurysms," said Dr. Cameron McDougall, director of Endovascular Neurosurgery and professor of Neurosurgery at The Johns Hopkins Hospital, and primary investigator for the FRED pivotal trial. "The pivotal study shows that a single FRED device is safe and effective for use in a variety of aneurysm sizes and locations and expands treatment options for patients."

"With our 3rd PMA approval by the Food and Drug Administration in 18 months, MicroVention is proud to introduce the FRED flow diversion device to the US. The FRED device helps address a need for a clinically proven flow diverter with simplified delivery," said Irina Kulinets, PhD, Sr. WW vice president of Regulatory Affairs, Clinical Research & Quality at MicroVention. "MicroVention is dedicated to the development of novel technologies that improve patient outcomes and quality of life. We are excited to bring the FRED device to patients in the US who will benefit from treatment."
 

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