OREANDA-NEWS. Takeda Pharmaceutical Company Limited (Takeda) today announced that the European Commission has granted an expanded indication for surgical patch TachoSil (human thrombin/human fibrogen) for use in adults for supportive sealing of the dura mater to prevent postoperative cerebrospinal leakage following neurological surgery. Dura mater is the outermost and most fibrous of the three membranes covering the brain and spinal cord.

TachoSil received Marketing Authorization in the European Union in June 2004. With the new expanded indication, TachoSil becomes the first and only dual action surgical patch approved in adults for:
-          Improvement of hemostasis, or the arrest of bleeding;
-          Tissue sealing;
-          Suture support in vascular surgery; and
-          Supportive sealing to prevent postoperative cerebrospinal leakage following neurological surgery.

“With the expansion of TachoSil’s indication, Takeda will bring the potential benefits of this important product to surgical teams and those patients undergoing lung, neurological and other types of surgery requiring rapid and efficacious sealing of surgical wounds,” said Alexander Konstantinidis, Global Program Leader, Takeda.

The new indication was supported by clinical data from a randomized controlled study in 726 patients undergoing skull base surgery. The study demonstrated the benefit of TachoSil in preventing postoperative leakage of cerebrospinal fluid and related complications compared to standard surgical practice.

“The use of TachoSil for dura sealing may benefit appropriate patients following neurological surgery by reducing the risk of postoperative cerebrospinal fluid leak. This may potentially avoid associated serious complications, such as infection after surgery, trauma and swelling of the brain," said Vilhelm Tetens, Global Clinical Lead, TachoSil, Takeda.