Company Watch

Baxter brings Tisseel to India

Sushmi Dey - New Delhi

Baxter India recently launched one of its internationally revolutionary products, Tisseel VH in India. While the product has been in use since last two years in the country, the company officials said that it was only imported as per the requests received from doctors. However, Tisseel had been officially launched in India in May 2007 by Baxter India. "The company plans to invest $200,000 in the Indian market and will be marketing the product in 40 hospitals in India, including SGRH. AIIMS, MAX and Army hospitals," said Kumar. Tisseel is a fibrin sealant used to seal tissues and stop diffuse bleeding with the help of highly concentrated human fibrinogen. It is used as an adjunct to homeostasis in surgeries involving cardiopulmonary bypass and treatment of splenic injuries due to blunt or penetrating trauma to the abdomen, when control of bleeding through conventional surgical techniques is ineffective or impractical. "Fibrin sealants are being propagated for high end surgeries where you do not want to risk going back and re-do the surgery to stop bleeding," explains Kumar.

Tisseel consists of a two component fibrin biomatrix that offers highly concentrated human fibrinogen to seal tissue and stop diffused bleeding. The two separate solutions are clottable human fibrinogen and bovine aprotinion, which is a fibrinolysis inhibitor.

The thrombin solution contains human thrombin and calcium chloride. When the solutions are combined, a clot is formed reproducing the final stages of the coagulation cascade. "Fibrin sealants duplicate the system of clotting that the body has anyways. The clotting mechanism is modified to work faster. This technique is a major advancement in liver surgery," says Dr Arvinder Soin, Senior Consultant Surgeon, Department of Liver Transplantation and Surgical Gastroenterology, SGRH. However, Baxter has no plans to manufacture the product in India. "We will continue to produce Tisseel from our two existing plants in Vienna (Austria) and California. The reason being that sit is a human product which is developed from humans, and therefore, we need identified donors who are regular, have no viruses and do not carry contaminated blood. These volunteer donors must come for a regular check up. Our donors are from specific parts of US and Europe," explains Kumar.

The company runs the integrated viral safety programme to manufacture Tisseel. The programme is divided in two stages - donor screening procedure and plasma inventory hold, and the viral inactivation by two step vapour heating. In the first stage donors are requalified through a comprehensive screening procedure. Along with other criteria, plasma donors are qualified only after they pass two consecutive sets of laboratory tests for viral markers.

"The donor selection system is designed to identify and retain highly motivated repeat donors," says Kumar. According to Kumar, Baxter's product is in use for the last ten years and the clinical trials in India are exempted by DCGI.

Reportedly, Reliance Life Sciences is the only other company to produce and market fibrin sealants in India. However, Baxter claims that Tisseel was the first commercial fibrin sealant to be approved by USFDA in 1998.