VANCOUVER, Oct. 9 /PRNewswire-FirstCall/ - Angiotech Pharmaceuticals, Inc. (NASDAQ: ANPI, TSX: ANP), a global specialty pharmaceutical and medical device company, today announced that it intends to file Premarket Notification 510(k) documents with the U.S. Food and Drug Administration (FDA) for its innovative, anti-infective 5-Fluorouracil-coated (5-FU) Central Venous Catheter (CVC).
"After reviewing the data from our recently completed clinical trial, we are extremely pleased that the 5-FU CVC pivotal study has hit its primary efficacy endpoint while showing an excellent safety profile. We are looking forward to presenting the full data set in a scientific symposium at the upcoming Critical Care Congress in February," said Dr. William Hunter, President and CEO of Angiotech.
"Based on the positive results from the U.S. pivotal trial, we will prepare a 510(k) package, which we expect to submit to the FDA in the fourth quarter of 2007. This is another important step towards commercializing our 5-FU CVC product line and our 5-FU anti-infective platform," continued Dr. Hunter.
"This is an exciting milestone for Angiotech. Our R&D efforts are striving to address two of the most common problems in surgery and medical devices: restenosis following vascular injury and infection related to medical device implantation. We continue to work towards achieving success in one of the most challenging areas of medical device development by deriving new and useful applications for our leading drug platforms, paclitaxel and 5-FU, and taking them from their early stages in the lab to their actual clinical use," added Dr. Jeff Walker, Senior VP, Research and Development for Angiotech.
The 5-FU CVC is expected to be
|SOURCE Angiotech Pharmaceuticals, Inc.|
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