These are the first FDA Premarket Approved stents for stent-assisted coil embolization.
MicroVention, Inc., announced the US Food and Drug Administration (FDA) Premarket Approval (PMA) for the Low-Profile Visualized Intraluminal Support Device (LVIS and LVIS Jr.) stents for stent-assisted coil embolization of intracranial aneurysms, making these the first and only stents PMA approved for stent-assisted coil embolization, and only the second PMA approved device designed for intracranial aneurysm treatment.
Previously approved for use in the US under a Humanitarian Device Exemption since 2014, the stents provide support for even the smallest neurovascular embolization coils for treatment of wide-necked saccular intracranial aneurysms.
“With their low-profile and consistent visibility, LVIS and LVIS Jr. stents expand the treatment options for patients with challenging, wide-necked aneurysms,” primary trial investigator, David Fiorella, MD, Stony Brook University Cerebrovascular and Stroke Center, said in a statement. “The pivotal trial shows that these stents are safe and effective for patients with aneurysms that may be challenging to treat with other devices.”
Created to include a braided comfortable, resheathable and retrievable design providing high metal coverage and end-to-end visualization, the stents are placed across the neck of the aneurysm, providing support for the blood vessel affected. Soft platinum coils are then pushed into the aneurysm, bunching together and blocking blood flow into the dilated space. The stents then prevent the coils from exiting the aneurysm and maintaining the pressure on the coils necessary to keep the aneurysm maintained.
The device comes in 2 sizes and features radiopaque markers and flared ends to help with positioning of the stent under fluoroscopy.
“The LVIS and LVIS Jr. stents address the growing preference of physicians for highly comfortable braided stents for aneurysm treatment,” Richard Cappetta, president, chief executive officer, MicroVention, Inc. said.