Product Safety

TEI Biosciences’ products are used and trusted by physicians and institutions around the world.
Our products have been applied in over a quarter of a million cases in over 50 countries. TEI’s first product was designed for use in the demanding discipline of neurosurgery to repair dura mater, including the protective layer surrounding the brain. All of our products are produced sharing the same stringent biotech processes in our ISO 13485/cGMP quality manufacturing facility, located in Boston, Massachusetts.All TEI Biosciences’ products are 510K cleared by the FDA and CE marked.

clean-roomKey safety parameters and attributes include:
Clinically Proven: TEI’s products have been broadly studied and are successfully used in cases ranging from dura repair and hernia repair to plastic and reconstructive surgery.Terminally Sterilized: TEI’s products are terminally sterilized via exposure to ethylene oxide gas to 10-6 SAL (sterility assurance levels), reducing the risk of blood-borne pathogens and transmission of disease. Many tissue repair products from other manufacturers are only aseptically processed and so do not provide the same level of assurances.

Viral Safety: TEI’s manufacturing process includes a chemical viral inactivation step validated to ensure inactivation of potentially contaminating virus classes, including enveloped & non-enveloped RNA and enveloped & non-enveloped DNA viruses.

Biocompatibility: The biocompatibility of TEI’s technology has been evaluated by a third-party laboratory in accordance with ISO 10993, the internationally recognized standard for medical implants intended for long-term use. The results show our technology to be highly biocompatible. The tests are summarized in the “TEI Product Technology Biocompatibility Summary” table at the bottom of this page.

TSE Safety

glovesOur products have been specifically designed to safeguard against the possibility of transmitting prion-related Transmissible Spongiform Encephalopathy (TSE) diseases, including variant Creutzfeldt Jakob Disease (vCJD), the human form of Bovine Spongiform Encephalopathy (BSE), commonly known as Mad Cow Disease.
The product is derived from fetal and neonatal bovine dermis, which has been designated safe by the World Health Organization and EU scientific committees as no detectable levels of infectivity have been identified for this type of tissue.1

Non-Inflammatory – Non-Irritant: Our products are pure, acellular collagen matrices that are free of contaminants, artificial chemical cross-links, and denatured proteins.

Source Materials: Our products are derived from only well-defined and characterized fetal and neonatal bovine source tissue with respect to age, mechanical strength, structure, and composition – a young and healthy tissue source of consistent thickness, predictable handling and application.

No Potentially Antigenic Antibiotics: Our products do not put the patient at risk for potential allergies to antibiotics.

No Polysorbate 20: Our products do not put the patient at risk for potential allergies to this cell lysing/preservative chemical.

 

TEI Product Technology Biocompatibility Summary3

Test Performed Standard Result
Cytotoxicity, MEM Elution ISO 10993-5 No evidence of causing cell lysis or toxicity
Sensitization, Maximization ISO 10993-10 No evidence of causing delayed dermal contact sensitization
Acute Intracutaneous Reactivity ISO 10993-10 No evidence of significant irritation
Acute Systemic Toxicity ISO 10993-11 No mortality or evidence of systemic toxicity
AMES Bacterial Reverse Mutation ISO 10993-11 Nonmutagenic to Salmonella typhimurium test strains TA98, TA100, TA1535, TA1537, and Escherichia coli strain WP2uvrA
Hemolysis, Modified
ASTM Direct Contact Method
ISO 10993-3 Nonhemolytic
Hemolysis, Modified
ASTM Extraction Method
ISO 10993-4 Nonhemolytic
Surgical Muscle Implantation, 4 & 12 Weeks ISO 10993-6 Macroscopically and microscopically classified as a non-irritant as compared to negative control plastic

For additional information, please download and reference the SurgiMend Safety and Handling data sheet.