CSL Behring’s Innovative HeliTraxSM System Helps Physicians Manage Hemophilia A Patients
Wireless Device Provides Comprehensive Clinical Picture, Improves Patient-Physician Communications
King of Prussia, PA — 25 August 2008
Hemophilia A patients who use Helixate® FS, Antihemophilic Factor (Recombinant), and their treatment providers are now tracking treatment progress in real time, thanks to the HeliTraxSM System, a state-of-the-art wireless Internet-based data management system recently introduced by CSL Behring. The system allows for a comprehensive view of a patient’s progress, with young patients relaying information about bleeding events and their use of Helixate FS to their hemophilia treatment center via the handheld device between office visits. The HeliTrax System, used in conjunction with Helixate FS treatment, is designed to improve patient-physician communications and therapy management.
"HeliTrax provides clinicians with the rapid, comprehensive clinical view they need to make assessments about treatment, it eliminates paperwork and helps to streamline patient data management," says Jill Leone, RN, CCRP, a hematology nurse who helped develop the system. "For young patients, HeliTrax helps them keep in touch with their therapy and motivates them to stay on track."
Physicians monitoring hemophilia A patients previously relied on paper forms filled out by the patients or their caregivers, which did not always provide necessary clinical information in a timely, clear and concise way. HeliTrax not only tracks a patient’s therapy as it happens - including medication usage and inventory - but allows the hemophilia treatment center to generate a one-page, easy-to-read, full-color clinical report of the patient’s progress. These private, secure reports, which help reduce documentation and transcription errors, are compliant with both the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and the Health Insurance Portability and Accountability Act (HIPAA). Additionally, the system is backed up every 48 hours, ensuring that the patient’s complete record is saved. CSL Behring has no access to patient data and all data are managed by a third-party company.
HeliTrax is also equipped with a camera to document bleeding events. Patients can quickly capture a high-quality picture of the bleed, which can then be seamlessly transmitted electronically to their treatment team, who can assess the seriousness of the event and often save the patient from making unnecessary trips to the emergency room.
"This innovative device uses cutting-edge technology to help those living with a bleeding disorder to manage their condition," said Garrett E. Bergman M.D., Senior Director of U.S. Medical Affairs at CSL Behring. "CSL Behring is committed to the bleeding disorder community and continues to develop creative management tools with the patient in mind."
Hemophilia primarily affects young males and managing their disease can be challenging for them and their parents. Shirley Smith of Hariman, Tennessee has been using the HeliTrax System to manage her 10-year-old son Tyler’s severe hemophilia and Factor VIII deficiency since October 2007.
"I love it," says Smith. "As complicated as things are when you have a child with hemophilia, the HeliTrax System just makes life 150 percent easier."
For more information about Helixate FS and HeliTrax, please go to www.cslbehring.com or call CSL Behring Consumer Affairs at 1-888-508-6978.
About Helixate® FS
Helixate® FS is a recombinant factor VIII treatment for hemophilia A that offers convenient administration with a 2.5-mL volume diluent; no available factor VIII product has a smaller diluent size. The 2000 IU vial size requires a 5.0 mL volume diluent.
No albumin is used in the formulation or purification of Helixate FS, and its manufacture includes a solvent/detergent viral inactivation step. The most frequently reported adverse event is local injection-site reaction. Known hypersensitivity to mouse or hamster protein may be a contraindication to the use of Helixate FS. In 2006, the FDA gave approval for Helixate FS to be stored at room temperature (up to 25°C, 77°F) for three months. The new storage guidelines for the treatment provide users with greater flexibility and simplify storage options.
Helixate FS is packaged with Mix2Vial, an easy-to-use, plastic, needle-free transfer device with a built-in filter. Use of the Mix2Vial helps minimize the risk of injury and reduces product preparation time.
Helixate® FS is manufactured by Bayer HealthCare LLC for CSL Behring LLC.
Hemophilia is an inherited bleeding disorder characterized by prolonged or spontaneous bleeding, especially into the muscles, joints, or internal organs. About 17,000 Americans have hemophilia. The disease is caused by deficient or defective blood coagulation proteins known as factor VIII or IX. The most common form of the disease is hemophilia A, or classic hemophilia, in which the clotting factor VIII is either deficient or defective. Hemophilia B is characterized by deficient or defective factor IX.
About CSL Behring
CSL Behring is a global leader in the plasma protein biotherapeutics industry. Passionate about improving the quality of patients' lives, CSL Behring manufactures and markets a range of safe and effective plasma-derived and recombinant products and related services. The company's therapies are used in the treatment of immune deficiency disorders, hemophilia, von Willebrand disease, other bleeding disorders and inherited emphysema. Other products are used for the prevention of hemolytic disease of the newborn, in cardiac surgery, organ transplantation and in the treatment of burns. The company also operates one of the world's largest plasma collection networks, ZLB Plasma. CSL Behring is a subsidiary of CSL Limited, a biopharmaceutical company with headquarters in Melbourne, Australia. For more information, visit www.CSLBehring.com.
Sheila A. Burke, Director, Communications & Public Relations
Worldwide Commercial Operations