FDA approves Medtronic’s Pipeline Flex aneurysm device

Medtronic (NYSE:MDT) said today that the FDA approved the Pipeline Flex embolization device it acquired along with Covidien last month, revealing plans for a limited U.S. release of the brain aneurysm treatment.

The latest iteration of the Pipeline device is designed to treat large and giant aneurysms by preventing blood from flowing into them, according to a press release.

Pipeline Flex, which Covidien itself bought along with ev3 for $2.3 billion in 2010, is indicated for complex intracranial aneurysms that can’t be clipped and are attached to parent vessels measuring between 2.5mm and 5.0mm in diameter, according to the release. The device won CE Mark approval in the European Union last June.

"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 of Florida’s Baptist Health said in prepared remarks. "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 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," Medtronic’s neurovascular president Brett Wall said in prepared remarks. "We are excited to bring new value to our medical community and patients."

The original Pipeline device, which 1st won a PMA nod from the FDA in April 2011, ran into trouble last year when Covidien issued an April recall for it and its Alligator retrieval device. Five months later Covidien had fixed the potentially lethal problem affecting the coating on the devices’ guidewires, winning FDA clearance in August 2014 to get them back on the U.S. market.

Medtronic paid $50 billion for Covidien last month in the largest medical device merger ever.