Percutaneous Vascular Access Device Approved
Source: Innerdyne, Inc.
InnerDyne Inc. (Sunnyvale, CA) has received FDA clearance for its Innervasc radially dilatable percutaneous vascular access device.Edited by Ursula Jones
In March 2000, InnerDyne granted exclusive U.S. and South American sales and distribution rights to the Innervasc product for percutaneous vascular access in the fields of cardiology, radiology, neuroradiology, and critical care to Maxxim Medical Inc.
"With receipt of our 510(k), InnerDyne has now met the conditions of our strategic marketing agreement with Maxxim to allow them to initiate the launch of the product," said William G. Mavity, president and CEO of InnerDyne.
It is estimated that more than 6 million percutaneous vascular procedures are performed each year worldwide, including more than 4 million procedures in the U.S. This represents annual market potential for the Innervasc system in excess of $300 million.
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