The U.S. has granted final approval to Microvention Inc., a subsidiary of Terumo Corp. based in Aliso Viejo, Calif., for its Flow Redirection Endoluminal Device (FRED) for the treatment of brain aneurysms. The flow diverter – Microvention’s third PMA approval in less than two years – is the first in the U.S. to utilize a self-expanding, braided nitinol mesh to aid in rerouting blood flow away from the weakened area and promote occlusion.
Brain aneurysms occur when a spot in the artery wall becomes weakened, causing it to bulge or balloon. An estimated 6.5 million Americans have an unruptured brain aneurysm, according to the Brain Aneurysm Foundation, most of which will never cause symptoms or pose a serious threat. However, about 30,000 people in the U.S each year suffer a brain aneurysm rupture, resulting in internal bleeding, stroke and, in roughly half of those, cases, death.
Already widely used
The nitinol design of the FRED system helps to facilitate its delivery to the target area, Microvention said, resulting in a reliable opening and interface with the vessel wall. The stent already has global experience. Since winning a CE mark in 2013, it has been used in close to 20,000 procedures.
In the U.S., it is indicated “for use in the internal carotid artery from the petrous segment to the terminus for the endovascular treatment of adult patients (22 years of age or older) with wide-necked (neck width ≥ 4 mm or dome-to-neck ratio < 2) saccular or fusiform intracranial aneurysms arising from a parent vessel with a diameter of ≥ 2.0 mm and ≤ 5.0 mm.”
The FDA based its approval on the FRED pivotal clinical trial, a single-arm interventional study involving 195 patients. Cameron McDougall, director of endovascular neurosurgery and professor of neurosurgery at The Johns Hopkins Hospital and the primary investigator for the pivotal trial, said the results showed that a single FRED device can safely and effectively treat a variety of aneurysm sizes and locations, increasing options for patients.
“The FRED device represents a step forward in flow diversion technology with the inclusion of the lowest profile delivery platform in the U.S.,” he said. “This advancement will allow physicians to more easily access and treat wide-necked or fusiform aneurysms.”
Growing portfolio of aneurysm products
Microvention’s FDA win with FRED comes close on the heels of two other PMA approvals. In May 2018, the agency gave a thumbs up to the company’s LVIS (low-profile visualized intraluminal support) and LVIS Jr. stents for stent-assisted coil embolization of intracranial aneurysms. The stent system had been available in the U.S. under a humanitarian device exemption (HDE) since 2014.
That was followed by FDA approval of the WEB (woven endo-bridge) aneurysm embolization system in late 2018. The WEB system is indicated for the treatment of intracranial wide neck bifurcation aneurysms and, according to Microvention, is the first PMA-approved device in the new category of intrasaccular flow disruptors for aneurysm embolization. It was developed by Sequent Medical Inc., which was acquired by Terumo in 2016, and earned a CE mark in 2016. In results from the global, single-arm, 150-patient WEB-IT study, published last April in the Journal of Neurointerventional Surgery, the Web system met all primary safety and effectiveness endpoints, with no follow-up bleeding events.
“With our third PMA approval by the Food and Drug Administration in 18 months, Microvention is proud to introduce the FRED flow diversion device to the United States,” said Irina Kulinets, senior worldwide vice president of regulatory affairs, clinical research and quality at Microvention. “The FRED device helps address a need for a clinically proven flow diverter with simplified delivery.”
In addition to the three aneurysm treatments, Microvention received FDA clearance in June 2018 of a new clinical indication for the SOFIA catheter (Soft TOrqueable catheter For Intracranial Access). The new indication is for contact aspiration technique for successful revascularization among patients with acute ischemic stroke, secondary to intracranial large vessel occlusive disease. The SOFIA catheter has been CE-marked for aspiration since 2015.
Competition in the brain aneurysm market is hot, with companies including Medtronic plc, Boston Scientific Corp. and Striker Corp. all vying for a piece of the pie. In May 2019, Stryker got the FDA green light for its Neuroform Atlas stent system for wide neck, intracranial aneurysms in conjunction with embolic detachable coils. Like the Microvention’s LVIS system, it was initially approved under an HDE.