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Embolic Protection Device Lands CE Mark
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A new system that protects against brain embolism during vascular procedures, including transcatheter aortic valve replacement, has received CE mark approval. This approval makes the device the first-ever system of filtration to protect both carotid arteries simultaneously, according to a press release.
The system (Montage, Claret Medical) utilizes a 6F cathether that can be delivered via the radial or brachial approach. It provides neuroprotection from debris and captures and removes embolic material that could potentially cause stroke, the release stated.
The approval was based on data from a European trial that examined 30-day patient outcomes. The manufacturer plans to continue to examine the device in clinical trials outside of the United States in early 2012.