Medtronic gains first FDA approval for Covidien device: Pipeline Flex for brain aneurysm

The Pipeline Flex--Courtesy Medtronic

Medtronic ($MDT) scored its first new FDA approval resulting from the acquisition of Covidien, which closed less than two weeks ago. The nod is for Pipeline Flex, a next-generation minimally invasive flow diversion device for unruptured aneurysm. It comes from Covidien's fast-growing, but tiny, neurovascular group.

This iteration is intended to enable more exact physician control and placement. It launched in Europe in June, after receiving a CE mark earlier last year. The first generation of the product, dubbed simply Pipeline, received FDA approval in 2011 as part of Covidien.

Medtronic expects to conduct a limited U.S. launch in the upcoming weeks.

"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," Dr. Ricardo Hanel, a neurosurgeon who is a clinical investigator for Pipeline Flex as well as the director of the stroke and cerebrovascular center at Baptist Health in Jacksonville, FL, said in a statement.

He continued, "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."

The Pipeline Flex product is part of the neurovascular portfolio within Medtronic's Restorative Therapies Group. Covidien's neurovascular segment was one of its fastest growing groups in its fiscal first quarter of 2015, which ended on Dec. 26, 2014. Over the same quarter a year earlier, it had a 9% gain in neurovascular product sales to reach $120 million. But that's a tiny fraction of the company's total fiscal first quarter product sales of $2.7 billion, which were up only 2%.

The Pipeline Flex has a braided cylindrical mesh tube that is implanted across the base or neck of an aneurysm. It cuts off blood flow to the aneurysm, thereby reconstructing the diseased section of the blood vessel.

Brett Wall

It is specifically intended 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 mm in diameter. About half a million people globally die each year due to ruptured brain aneurysm, most of whom are younger than 50 years old, according to the company.

"The Pipeline Flex embolization device is the next advancement in flow diversion, combining our clinically proven braid design with a new delivery system designed to offer improved accuracy and control when performing these advanced procedures inside the brain," Brett Wall, president of the Neurovascular group at Medtronic, concluded in a statement.

- here is the release