Aliso Viejo, Calif.-based MicroVention said the federal safety watchdog approved its low-profile visualized intraluminal support devices for stent-assisted coil embolization of intracranial aneurysms.
Previously approved under a humanitarian device exemption, the LVIS and LVIS Jr. stents are designed to stabilize the blood vessel around the opening to a wide-neck aneurysm while a coil is deployed within the aneurysm and then retrieved after the coil is in place.
“The LVIS and LVIS Jr. stents address the growing preference of physicians for highly conformable braided stents for aneurysm treatment. Thousands of patients globally have benefited from this technology and we are pleased to have achieved the most rigorous standard of FDA approval to support our customers’ usage,” MicroVention president & CEO Richard Cappetta said in prepared remarks.
“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,” added principal investigator Dr. David Fiorella of the Stony Brook University Cerebrovascular & Stroke Center.