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ev3 Inc.

Division of Medtronic PLC

Latest From ev3 Inc.

Medtronic Biz Pleads Guilty In Off-Label Marketing Case

A Medtronic subsidiary has agreed to plead guilty for off-label marketing activities that occurred prior to Medtronic's acquisition. Overall, the firm says it has settled three investigations with a total pay-out of $50.9m. US FDA is underscoring the case as an example of the agency pursuing companies that "put profit over safety."

Enforcement Compliance

Appeals Court Rejects False Claims Approach To FDA Off-Label Cases

A ruling from the First Circuit suggests that plaintiffs can’t prove manufacturers violated the False Claims Act by suggesting FDA submissions were fraudulent, if FDA itself hasn’t taken any action against the manufacturer.

Legal Issues Government Payers

Market Update: Growth And Opportunities In Peripheral Artery Disease

Drug-coated balloon (DCBs) catheters have become the latest weapon in the fight against peripheral artery disease in the US, although they have been in use in Europe for some time. While the number of procedures employing DCBs is still dwarfed by conventional angioplasty procedures, they are expected to grow at a much faster rate, fueling a market projected to reach $1 billion by 2020; meanwhile other procedures such as mechanical atherectomy are also expected to show significant growth.

Medical Device Innovation

Research In Brief

Covidien's Pipeline aneurysm device shows 8.5% major complication rate in early post-market results. Surprise at long-term results for endovascular repair of abdominal aortic aneurysms. More clinical trial news.

Medical Device Clinical Trials
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