FDA expands indications for Medtronic’s Pipeline Flex embolization device

Medtronic (NYSE:MDT) said today it won expanded FDA approval for its Pipeline Flex embolization device.

The device is now indicated for patients with small or medium, wide-necked brain aneurysms in the territory from the petrous to the terminus of the internal carotid artery, the Fridley, Minn.-based company said.

The Pipeline Flex was previously cleared for the endovascular treatment of adults with large or giant wide-necked intracranial aneurysms from the petrous to the superior hypophyseal segments, Medtronic said.

Clearance came based on data from the 141-patient PREMIER trial of the device, which reported a one-year average occlusion rate of 76.7% with the use of 1.1 device per subject on average and an average 2.2% rate of major stroke or neurological death, the company said.

“Premier is another landmark study with Pipeline and moves the bar on the safe treatment of wide-necked brain aneurysms. This data changes the way we, as physicians, think about using Pipeline Flex to treat our patients,” principal trial investigator Dr. Ricardo Hanel of Jacksonville, Fla.’s Baptist Health said in a prepared statement.

The Pipeline Flex device is designed to divert blood away from aneurysms and features a braided cylindrical mesh tube intended to be implanted across the base of the neck of the aneurysm, which cuts off blood flow and reconstructs the diseased section of the parent vessel.

“Working hand-in-hand with physicians to develop new technology and clinical data is at the core of our mission. The Premier study not only demonstrated excellent safety and efficacy outcomes but also delivered on our commitment to broadening access to innovative therapies for new groups of patients requiring aneurysm treatment,” neurovascular biz GM Stacey Pugh said in a press release.

Late last month, Medtronic said that new study data indicated that its thoracic stent graft, intended for the treatment of a potentially deadly blunt-force chest injury, performed well at five years post-implantation.

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