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Jan B. Wade · #1 (**permalink**) 05-23-2005, 05:48 PM

Extended Indication for Quixil(R) Human Surgical Sealant in Surgery
Extended Indication for Quixil(R) Human Surgical Sealant in Surgery

NATICK, Mass., May 23 /PRNewswire-FirstCall/ -- Boston Scientific Corporation today announced that the U.S. Food and Drug Administration (FDA) has approved extending the shelf life of its TAXUS(R) Express2(TM) paclitaxel-eluting coronary stent system in the United States to twelve months from the current shelf life of nine months. The decision was based on data submitted by Boston Scientific to the FDA that demonstrated the performance of the TAXUS system -- in particular the drug content, drug degradation profile and drug-release mechanism -- was maintained within FDA-approved specifications at twelve months. The new TAXUS U.S. shelf life is longer than any competing product.
Quixil(R) Human Surgical Sealant is now approved for use in supportive treatment during surgery for improvement of haemostasis, where standard surgical techniques are insufficient. It was previously only indicated for liver surgery and orthopaedic surgery in large joint replacement, where efficacy is proven(1,2). (It remains contraindicated in neurosurgery and procedures where contact with CSF and the dura mater could occur).

LONDON, May 23 /PRNewswire/ -- Quixil(R) Human Surgical Sealant is now approved for use in supportive treatment during surgery for improvement of haemostasis, where standard surgical techniques are insufficient. It was previously only indicated for liver surgery and orthopaedic surgery in large joint replacement, where efficacy is proven(1,2). (It remains contraindicated in neurosurgery and procedures where contact with CSF and the dura mater could occur).

The new indication follows the publication of new Fibrin Sealant Guidelines in January 2005, which means that the indication for use is no longer limited to the procedures in which trials have been performed. Quixil(R) is the first fibrin sealant which has had its use approved to meet these new guidelines.

In traditional fibrin sealants, bovine sourced proteins are present. However, Quixil(R) is the only sealant that is completely free of animal sourced components. Quixil(R) is ready for application in less than one minute after thawing and is more adherent and flexible than traditional fibrin sealants, even at low temperatures potentially lowering sepsis rates.(6) It is less likely to crack or peel away and the triple lumen design of the catheter avoids clogging which allows the same applicator tip to be used throughout the surgical procedure.

A two-component, single use surgical sealant, Quixil(R), consists of a biological active component (BAC) - human clottable protein and tranexamic acid - and thrombin. It mimics the final steps of the physiological coagulation cascade achieving haemostasis and functions independently of the bodyâ€™s coagulation mechanism to work on patients with coagulopathies or on anticoagulation therapy.

Mr Rajiv Vohra, FRCS, consultant vascular surgeon at University Hospital Birmingham, Selly Oak, comments: â€™This will be a useful adjunct to a wide range of surgical procedures, particularly following the blood donation selection criteria introduced in April 2004 by the UK Blood Services. This limitation to already restricted blood supplies means surgeons may now consider Quixil(R) an integral tool in blood conservation techniquesâ€™.

Each of the Quixil(R) components undergoes two separate and different virus inactivation and removal steps during manufacturing to reduce the risk of transmission of non-enveloped viruses and add an additional margin of safety with respect to enveloped viruses. This also increases the probability of inactivating unidentified pathogens. The BAC component is treated with solvent detergent followed by pasteurization. The Thrombin component undergoes solvent detergent treatment with subsequent nanofiltration.

Clinical trials in liver and orthopaedic surgery have shown that Quixil(R) can achieve rapid haemostasis even on large oozing and bleeding surfaces that cannot be controlled by conventional surgery alone.(1,2) In the context of liver surgery the use of Quixil(R) decreases operative time and significantly reduces the occurrence of postoperative complications related to haemostasis.(1) Reduced blood transfusion requirements have been demonstrated when Quixil(R) was used in orthopaedic surgery.(1,2,3,4,5)

Notes to Editors

Quixil(R) is a registered trademark of OMRIX biopharmaceuticals S.A.,Belgium. Quixil(R) is marketed in the UK by Johnson & Johnson Wound Management

References

1.Schwartz, et al: Comparison of a New Fibrin Sealant With Standard Topical Hemostatic Agents; Arch Surg. 2004;139:1148-1154.

2. Martinowitz, U., Levy, O., Tauber, C., Oran, A., and Horoszowski, H. (1997, June). Prospective randomized multi-center study on safety and efficacy of fibrin tissue adhesive in knee arthroplasty. XVIth Congress of the International Society on Thrombosis and Haemostasis, Florence, Italy, Thrombosis Haemostasis Supplement 1997:368.

3. Wang, G.J., Hungerford, D.S., Savory, C.G., Rosenberg, A.G., Mont, M.A.., Burks, S.G., Mayers, S.L., and Spotnitz, W.D.. (2001). Use of fibrin sealant to reduce bloody drainage and hemoglobin loss after total knee arthroplasty. Journal of Bone and Joint Surgery. 83-A (10), 1503-1505.

4. Crawford, R.W., Giangrande, P., Murray, D. (1999). Fibrin sealant reduces blood loss in total hip arthroplasty. Hip International, Official Journal of the European Hip Society. 9(3), 127-132

5. Levy, O., Martinowitz, U., Oran, A., Tauber, C., and Horoszowski, H. (1999, November). The use of fibrin tissue adhesive to reduce blood loss and the need for blood transfusion after total knee arthroplasty. Journal of Bone and Joint Surgery. 81-A (11), 1150-1588

6. Heaton, N., (2005, June). Advances and Methods in Liver Surgery: Haemostasis. European Journal of Gastroenterology and Hepatology. S11

Indication: QUIXIL(R) is used as supportive treatment in surgery where standard surgical techniques are insufficient, for improvement of haemostasis. Efficacy has been demonstrated in liver surgery and orthopaedic surgery in large joint replacement.

Please refer to the full Summary of Product Characteristics when prescribing. Available from J&J Customer Services on +44(0)800-864060.