General and Advanced Surgery
Biocompatible silicone technologies meeting the strict medical and regulatory requirements of Medical devices used in an operating room
Medical grade Silicones for General and Advanced Surgery
Medical grade silicones have long been used in Medical applications as a result of their biocompatibility, chemical inertness, hypo-allergenicity, high performance physical properties and stability across a wide range of environmental conditions.
Manufacturers and OEMs who serve the healthcare industries use a wide range of Silbione™ Silicones to make medical parts and devices supporting care givers and patients in the operating room, including:
Fluid management in medical devices – such as tubing, catheters and valves – plays a critical role in healthcare and patient wellbeing. Elkem Silicones provides a standard and a self-lubricating range of Silbione™ Liquid Silicone Rubber, enabling manufacturers to design and produce safe and reliable medical valves including needle-free access valves.
More and more patients need to be implanted with Cardiac Resynchronization devices (e.g. pacemakers), which quickly adjust abnormally high heart rhythms or other life-threatening cardiac anomalies. The silicones used in these critical and very precise devices must meet the strict requirements for long-term Implants to efficiently ensure patient safety over time.
Neurostimulation devices are typically surgically implanted in the patient and function through thin wires or leads. Implantable grade Silbione™ Biomedical can be used for making gaskets, seals, adhesives, lead insulators, and drug delivery systems in active implantable neurostimulation or neuromodulation devices and applications, including Cochlear Implants and Chronic Pain Treatment.
Stents are designed to keep pathways open within the human body and often require additional biocompatible silicone coating to provide corrosion resistance and to decrease the amount of tissue ingrowth. Biomedical grade silicones can also be used as drug eluting matrices to release specific APIs from the stent.
Silbione™ medical 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
- Certified ISO 9001
- Application of the Responsible Care Management System®
At Elkem Silicones, we believe in the safety and efficacy of our silicone products for healthcare and biomedical applications. Our medical Silbione™ products have been tested to meet USP Class VI and ISO 10993 requirements. Our regulatory support team is available to support customers with biocompatibility needs, either directly by providing the relevant documentation, or by supplying information to regulatory agencies in support of their medical device submissions.
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. If you have a medical device project, contact us and our experts will be there to help.