FDA OKs Brain Aneurysm Device from Medtronic

Yours, mine and ours. Medtronic plc—just a few weeks into its marriage with Covidien—reports that the  U.S. Food and Drug Administration (FDA) has approved the Pipeline Flex embolization device—a technology that had been part of Covidien’s stable of devices. Covidien, however, had inherited the device from its purchase of Ev3 in 2010.

The device will be available through a limited U.S. launch in the coming weeks. Medtronic calls the launch the “latest-generation flow diversion device represents an unrivaled advancement in large and giant brain aneurysm treatment.”

“Flow diversion has been a major breakthrough therapy for large or giant wide-necked brain aneurysms that are complex and have considerably higher risk of rupture and higher rates of complication with conventional treatment,” said Ricardo Hanel, M.D., neurosurgeon and director of the Stroke and Cerebrovascular Center at Baptist Health in Jacksonville, Fla. “With thousands of patients successfully treated with Pipeline Embolization Device, the Pipeline Flex’s innovative delivery system will result in further advancing endovascular treatment and care.”

Designed to divert blood flow away from an aneurysm, the Pipeline Flex embolization device features a braided cylindrical mesh tube that is implanted across the base or neck of the aneurysm. The device cuts off blood flow to the aneurysm, reconstructing the diseased section of the parent vessel.

The device received CE mark in June last year, while earlier iterations have been approved by the FDA.

“The Pipeline Flex embolization device is the next advancement in flow diversion, combining our clinically-proven braid design2 with a new delivery system designed to offer improved accuracy and control when performing these advanced procedures inside the brain,” said Brett Wall, president of Medtronic’s neurovascular business. “We are excited to bring new value to our medical community and patients.”

In the United States, the Pipeline Flex device is intended for use for the endovascular treatment of complex intracranial aneurysms that are not amenable to treatment with surgical clipping and are attached to parent vessels measuring between 2.5 and 5.0 millimeters in diameter. An estimated 500,000 people throughout the world die each year caused due to ruptured brain aneurysms, and half the victims are younger than 50 years of age, according to figures cited by the company.

The first-generation Pipeline embolization device has been used to treat patients in the United States since it was approved by the FDA in 2011. This product is part of the neurovascular portfolio in Medtronic`s Restorative Therapies Group.

Medtronic is headquartered in Dublin, Ireland.