An FDA panel gave the nod to Covidien plc’s (NYSE:COV) Pipeline embolization device, recommending that it be approved to treat large brain aneurysms.
Covidien acquired the technology with its $2.6 billion buyout of ev3 Inc. last year. The Pipeline device is designed to treat large, giant and wide-necked brain aneurysms. It’s a coil of wire delivered to brain aneurysms via catheter, designed to encourage blood to clot around them to relieve pressure. Aneurysms involve weak portions of blood vessel walls, which pouch out from the pressure within the vessel and are at risk of bursting.
Last summer, just after the acquisition was announced, the FDA granted expedited review to Ev3’s pre-market approval application for Pipeline. At the time the company said a 108-patient clinical trial of the device was examining its suitability for treating large aneurysms that aren’t typically coiled.
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At the FDA’s Neurological Devices Advisory Panel hearing, the committee voted unanimously to recommend approval, according to Covidien, based on results from the clinical trial.
The Pipeline device won CE Mark approval in Europe and has been sold outside the U.S. since July 2009, according to Mansfield, Mass.-based Covidien.
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A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.
