Cardiac Resynchronization Devices

Manufacturers of long-term medical implants (defined as devices inserted in the human body for 29 days or more) use silicones in the manufacturing of 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.

Medical Grade High Consistency Rubber for Healthcare application

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These materials can be transformed 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:

• Pacemakers
• Implantable Cardioverter Defibrillators (ICD)
• Pacing/ICD leads
• Heart Pumps or Ventricular Assist Devices (VAD)
• Power cables and strain reliefs

Silbione™ 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®

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The biocompatibility of Silbione™ Biomedical grade silicones is tested according to ISO 10993/USP Class VI procedures, which include:

• 12-week implant tests
• Hemolysis
• USP Intracutaneous Reactivity
• USP Acute Systemic Toxicity
• Cytotoxicity
• Mutagenicity & pyrogenicity
• Skin Sensitization
• Tissue Irritation

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).

At Elkem Silicones, we are dedicated people located around the globe, committed to your success. Whether you are looking for a product recommendation, for customized silicone solutions, or for regulatory support, we have the people in place when and where you want them.