- Medtronic's application for an expanded indication for its Pipeline Flex embolization device has been approved by FDA, the device giant said Thursday.
- The device, first approved for endovascular treatment of adults with certain large or giant wide-necked intracranial aneurysms, is now also indicated for patients with certain small or medium aneurysms.
- The product falls within Medtronic's Restorative Therapies Group, which grew 7% to $1.99 billion in revenue during the company's 2019 second quarter. Within the group, brain therapies grew 7.5% to $618 million, with its neurovascular division posting growth in the mid-teens.
The Brain Aneurysm Foundation estimates about six million people in the United States have an unruptured brain aneurysm, with 30,000 annually experiencing a rupture. Worldwide, more than 500,000 die of causes related to brain aneurysms per year.
The expanded indication approval for Medtronic's embolization device was supported by an interventional single-arm clinical trial that studied the device in 141 patients with certain unruptured wide-neck intracranial aneurysms measuring ≤ 12 mm. The device works by diverting blood flow away from an aneurysm after being implanted to help reconstruct the artery.
The study, deemed the PREMIER trial (PRospective study on EMbolization of Intracranial anEuRysms with the Pipeline device) found 2.2% of patients experienced a major stroke or neurological death. There were zero aneurysm recurrences with occlusion rates of 76.7% at the 1-year mark post-procedure.
Medtronic is holding its 2019 third quarter earnings call on February 19. The company's stock was up slightly in early morning trading.