Neurostimulation Devices

Silbione® Biomedical Grade silicones are manufactured to meet the strict medical and regulatory requirements for neurostimulation or neuromodulation devices.

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​Silbione® Biomedical Grade silicones for implantable neurostimulation devices

Neurostimulation is an advanced treatment for reducing certain types of chronic pain and is also used to improve the quality of life of people who are paralyzed or suffering from severe losses to sense organs. It is used, for example, as a key element in neural prosthetics for hearing aids, artificial vision, artificial limbs, brain-machine interfaces, etc.

Neurostimulation devices are surgically implanted in the patient and function through thin wires or leads. They are effective therapeutic solutions for pain brought on by various medical conditions, such as diabetic neuropathy or failed back surgery. They not only soothe patients, but also avoid the use of strong pain killers, including opiates.

These materials can be produced using a variety of manufacturing processes including injection, compression, and transfer molding, as well as extrusion. They are used for making gaskets, seals, adhesives, lead insulators, and drug delivery systems in active implantable neurostimulation or neuromodulation devices and applications, including:

  • Cochlear Implants
  • Chronic Pain Treatment
  • Implantable Sleep Apnea Treatment
  • Obesity Treatment

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®

Biocompatibility

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® implant grade silicones are also given full Master-file Support through Device Master Access Files (MAF) at the FDA Center for Devices and Radiological Health (CDRH). The FDA Center for Devices and Radiological Health (CDRH).

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Neurostimulation Devices

 

 

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