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June 23, 2014

Covidien's Pipeline Flex Embolization Device Launched in Europe

June 24, 2014—Covidien announced the European launch of the Pipeline Flex embolization device for the endovascular embolization of cerebral aneurysms. The company’s next-generation flow diversion device received European CE Mark approval earlier this year. The device is part of Covidien’s line of neurovascular products to treat unruptured brain aneurysms. The company announced the launch during the annual LINNC: Live Interventional Neuroradiology & Neurosurgery Course in Paris, France, on June 23–25. 

According to Covidien, the Pipeline Flex features a braided cylindrical mesh tube that is implanted across the base or neck of the aneurysm. The device cuts off blood flow to the aneurysm, reconstructing the diseased section of the parent vessel. The device is repositionable and designed for accuracy and controlled placement. An instant braid release system facilitates easy placement.

The company noted that the first-generation Pipeline embolization device has been used to treat patients in Europe since 2009 and in the United States since receiving US Food and Drug Administration approval in April 2011. The next-generation Pipeline Flex device is not currently approved for use in the United States, advised Covidien.

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June 25, 2014

FDA Seeks to Encourage Medical Device Data System Innovation

June 23, 2014

Philips Launches NeuroSuite Imaging System in Europe


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