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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.
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.
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.
The treatment of acute ischemic stroke and brain aneurysms is rapidly evolving. New transcatheter devices and adjuvant imaging promising to improve outcomes and reduce the burden of neurovascular disease. However, to really spur this market, long-term, large-scale clinical trials are needed.
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