FDA approves Medtronic’s Pipeline Flex aneurysm device

February 5, 2015 By Brad Perriello Leave a Comment

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.

DeviceTalks Weekly Podcast: Deconstructing medtech’s alphabet soup – DPA, MDR, FDA are all in the news
In this week’s DeviceTalks Weekly, we’ll examine how governmental effort, both foreign and domestic, are hitting the medtech industry. Our guests include Tracy Eberly, CEO of Fang Consulting, a regulatory advisory group. Eberly will update listeners on what pushing back the MDR deadline could mean for medtech companies and why some companies may be less than… […]
AdvaMed: Invoking Defense Production Act could hinder U.S. medtech imports
Forcing manufacturers to repurpose their production lines to make equipment to fight the coronavirus epidemic might actually hurt the U.S. supply of those items, the head of medtech trade group AdvaMed said today. AdvaMed officials have talked with U.S. secretary of Health and Human Services Alex Azar and FDA commissioner Dr. Stephen Hahn about medtech… […]
March 2020 Issue: Is software key to medical 3D printing innovation?
What’s the word on ethylene oxide? The coronavirus pandemic has pushed a lot of news out of people’s minds, but medtech has other big issues to deal with. For instance, 8 months have passed since the FDA issued a public challenge for alternatives to ethylene oxide (EtO) as a sterilant for medical devices. As I… […]
GE Healthcare quadruples ventilator production at Wisconsin plant
General Electric Healthcare (NYSE:GE) this week announced that it is doubling its production capacity for ventilators and expanding its Madison, Wisconsin, production line to 24-hour operation. In a report on GE’s website, the company shared that it has doubled its capacity of ventilator production with plans to double it again by the end of the second… […]
FDA issues FAQ on 3D-printed equipment against coronavirus
Intrepid 3D printing companies and individuals who want to print masks, gowns and other personal protective equipment (PPE) to fight the coronavirus pandemic might want to take a look at the FDA’s new frequently asked questions page on the topic. While it says it welcomes coronavirus-fighting efforts, the agency said that 3D-printed masks are unlikely… […]
Software is enabling medical 3D printing innovation: Here’s how
The 3D printers themselves get a lot of attention, but for 3D-printing to become ubiquitous in the medtech space, software will have to play a key role. A 3D printer without software to tell it where to place the material is a really nice, expensive coffee table, according to Scott Rader, a former Stratasys GM… […]
This open source ventilator hackathon could help fight the coronavirus
Infineon engineers developed a 3D printed lung ventilator to help address the shortage of ventilators due to the COVID-19 pandemic. The German federal government held a hackathon called #WirvsVirus (“We against the virus”) where 42,000 people met to find solutions to challenges from the coronavirus. Infineon engineers, led by Mahmoud Ismail who has a doctorate… […]
Could these DIY ventilators stop coronavirus from killing people?
Amid the global crisis caused by the coronavirus pandemic, hospitals and healthcare facilities are reporting shortages of vital equipment that not only keeps the patients safe, but the staffers, too. One important device for which demand has ramped up is ventilators for patients who need assistance with their breathing due to the respiratory effects of… […]
DIY ventilators? Not unless there’s a zombie apocalypse.
News reports of the COVID-19 virus have given a lot of space to the shortage of respiratory ventilators. The Society of Critical Care Medicine claims at least 950,000 U.S. patients could need ventilators but hospitals only have 160,000. One response to statistics like these has been a movement among open-source promoters to initiate community-designed ventilators… […]
FDA announces EUAs related to ventilators to treat coronavirus
Amid a shortage of ventilators for treating coronavirus, the FDA put out a statement confirming its stance on issuing emergency use authorizations for potential temporary fixes. The FDA said it is operating on the basis of a EUA determination that the U.S. Dept. of Health and Human Services issues on Feb. 4. Earlier this week, HHS declared… […]
Hack the Crisis: Life-saving pneumatics from Emerson’s ASCO and Aventics
As the United States continues to focus on social distancing to combat COVID-19, more companies are revealing how the move home for their workers is impacting their business. Despite this, companies like Emerson’s ASCO and Aventics divisions continue to step up production on key technologies used in life sciences and laboratories, including ventilators, respirators, hospital… […]