Medtronic's Pipeline Flex Embolization Device Receives FDA Approval

February 5, 2015—Medtronic plc announced that it has received US Food and Drug Administration (FDA) approval for its Pipeline Flex embolization device, which will be available in the United States through a limited launch in the coming weeks. 

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 mm in diameter. 

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. The Pipeline devices were developed by Covidien, which merged with Medtronic on January 26.

The company stated that the Pipeline Flex 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.

In the company’s press release, neurosurgeon Ricardo Hanel, MD, commented, “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. 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.” Dr. Hanel is Director of the Stroke and Cerebrovascular Center at Baptist Health in Jacksonville, Florida.