Silicone keeping cardiac resynchronization devices safe from corrosive body fluidsManufacturers of long-term medical implants (defined as devices inserted in the human body for 29 days or more) use silicone ingredients and formulations to make a wide range of products, including pacemakers and other devices used in cardiac resynchronization therapy (CRT). These devices quickly adjust abnormally high heart rhythms or other life-threatening cardiac anomalies. The silicones used in these critical and very precise devices must always be biocompatible, reliable and chemically inert to efficiently ensure the protection of sensitive components from corrosive body fluids. Elkem Silicones Silbione™ Biomedical implantable Medical Grade silicones are specially designed and manufactured to meet all these requirements and deliver high performance and stability in a wide range of biological conditions.These materials can be produced using a variety of manufacturing processes including: injection, compression, and transfer molding, as well as extrusion. They are the key materials for making gaskets, seals, adhesives, lead insulators, and drug delivery systems in active implantable CRT devices, including:PacemakersImplantable Cardioverter Defibrillators (ICD)Pacing/ICD leads Heart Pumps or Ventricular Assist Devices (VAD)Power cables and strain reliefsSilbione™ Biomedical grade silicones meet the highest quality and manufacturing standards, complying with the Elkem Silicones Quality Management System. This includes: Inhouse clean operation standards, applying the principles of Good Manufacturing Practices (GMP) for medical devices and ISO 14949 guidelines Certified ISO 9001 Manufacturing Facilities Certified ISO Class 8 Manufacturing Environments Certified ISO Class 7 Packaging Environments Application of the Responsible Care Management System® The biocompatibility of Silbione™ Biomedical grade silicones is tested according to ISO 10993/USP Class VI procedures, which include: 12-week implant testsHemolysis USP Intracutaneous Reactivity USP Acute Systemic Toxicity Cytotoxicity Mutagenicity & pyrogenicity
Silbione™ medically implantable silicones are also given full Master-file Support through Device Master Access Files (MAF) at the FDA Center for Devices and Radiological Health (CDRH).