MicroVention's LVIS Devices Approved for Stent-Assisted Coil Embolization of Intracranial Aneurysms
May 31, 2018—MicroVention, Inc., a United States–based subsidiary of Terumo, announced US Food and Drug Administration (FDA) premarket approval for the LVIS (low-profile visualized intraluminal support) and LVIS Jr. stents for stent-assisted coil embolization of intracranial aneurysms. The LVIS and LVIS Jr. stents have been approved for use in the United States under an FDA humanitarian device exemption since 2014.
According to the company, the LVIS and LVIS Jr. stents feature a braided, conformable, resheathable, and retrievable design that provides high metal coverage and end-to-end device visualization to provide support for even the smallest neurovascular embolization coils for the treatment of wide-necked saccular intracranial aneurysms.
David Fiorella, MD, commented in the company's announcement, "With their low-profile and consistent visibility, LVIS and LVIS Jr. stents expand the treatment options for patients with challenging, wide-necked aneurysms. The pivotal trial shows that these stents are safe and effective for patients with aneurysms that may be challenging to treat with other devices." Dr. Fiorella is the primary investigator of the pivotal trial. He is Professor of Neurological Surgery and Radiology, Director of Neurointerventional Radiology, and Co-Director of Stony Brook University Cerebrovascular and Stroke Center in New York, New York.