•Surgical patch TachoSil® – first and only dual action patch for general tissue sealing
ZURICH, Switzerland, Feb. 17, 2009--Today Nycomed received an expanded indication for TachoSil®, its innovative surgical patch, from the European Medicines Agency (EMEA). To date, TachoSil was approved for haemostasis (control of bleeding) in surgery. With the new expanded indication, it becomes the first and only dual action patch approved for haemostasis, tissue sealing as well as for suture support in vascular surgery.
TachoSil is the key product in Nycomed’s tissue management portfolio and effectively fulfils the market need for a ready-to-use surgical patch, developed to assist surgeons in achieving fast and reliable bleeding control. Now, with the new expanded indication, Nycomed can offer a dual action patch approved for haemostasis, tissue sealing as well as for suture support in vascular surgery.
“With the expansion of TachoSil’s indication, Nycomed will bring the benefits of this unique product to surgical teams and those patients undergoing lung or other types of surgery requiring rapid air or body fluid sealing,” said Lone Nørgaard Andersson, International Brand Manager at Nycomed.
The new indication was filed with the EMEA in 2008, based on international clinical trial results on lung and cardiovascular surgery. TachoSil is currently available in Europe and Russia/CIS. In the United States, the product will be marketed by Baxter International Inc., while Nycomed will manufacture it and be responsible for the US regulatory filing.
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