FDA CLEARS ENPATH MEDICAL'S STEERABLE SHEATH
Enpath Medical has received FDA marketing clearance for the company's steerable sheath as a stand-alone device for a number of procedural indications including interventional coronary, peripheral vascular and carotid artery access.
The company is in early discussions with other potential partners regarding distribution of iterations of the product for other attractive market segments.
The company has also signed an exclusive license and supply agreement with Bard Electrophysiology, a division of C. R. Bard, for distribution of the product in the electrophysiology market. Although terms of the agreement were not disclosed, the company stated that the agreement was subject to the completion of intellectual property due diligence and Enpath attaining CE mark approval for the device.
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