Self- Contained Needleless Reconstitution System Introduced For Hemophilia A Treatment
Berkeley, CA - Bayer HealthCare, LLC., announced that Kogenate FS (Antihemophilic Factor (Recombinant), Formulated with Sucrose), its recombinant factor VIII hemophilia A treatment, is now available with BIO-SET needleless reconstitution system in the United States. Approved by the United States Food and Drug Administration (FDA), BIO-SET is the first and only integrated reconstitution system for recombinant factor VIII that reduces the risk of accidental needle-stick injuries during reconstitution.
With its simplicity, safety, and convenience, Kogenate FS with BIO-SET represents a new standard for the reconstitution and delivery of factor VIII. Compared to currently available systems, Kogenate FS with BIO-SET involves fewer components for reconstitution and offers a compact size for easy portability. It will advance patient safety as there is no exposure to needles during the reconstitution process, no latex utilized in the system, and minimal risk of contamination. It was designed to satisfy the expressed needs of today's hemophilia A community who seek an easy and fast way to reconstitute and administer recombinant factor VIII.
Jeremy Short is a twenty-five-year-old graduate student at the University of Arizona College of Pharmacy living with hemophilia A, but having the condition has not stopped him from living the life he chooses. "Treatment advances have helped fit hemophilia into my life rather than the other way around," said Jeremy. "Attending graduate school and working full-time doesn't leave me with much free time, so I want treatment options that offer more convenience. By offering fewer preparation steps, fewer exposed needles, and better portability, I feel Kogenate FS with BIO-SET will be a treatment option that fits well into my active life."
Jeremy's comments mirror the results from a recently published study in the Journal of Outcomes Research that compared recombinant factor VIII reconstitution systems. The study showed 74 percent of respondents -- including patients, caregivers, and healthcare professionals -- preferred Kogenate FS with BIO-SET over standard reconstitution methods. In fact, Kogenate FS with BIO-SET ranked as "favorite device overall" compared to other reconstitution systems.
"At the core of Bayer HealthCare's research and development process is an ongoing dialogue with the community about current and emerging needs," said Terry Tenbrunsel, Vice President, Sales and Marketing, Bayer HealthCare. "BIO-SET was developed to satisfy the community's expressed need for innovative products that simplify the reconstitution and administration of recombinant factor VIII. We are excited to offer Kogenate FS with BIO-SET to our customers in the United States."
SOURCE: Bayer HealthCare AG