Integra LifeSciences Collagen Membrane, HeliMend - Manual (Page 4)

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Indications
HeliMend absorbable collagen membrane is an absorbable, implantable
material that is indicated for guided tissue regeneration procedures in
periodontal defects to enhance regeneration of the periodontal apparatus.
Contraindications
HeliMend absorbable collagen membrane is contraindicated in patients
who have acute infections or contaminated wounds in the oral cavity.
HeliMend absorbable collagen membrane is contraindicated in clinical
situations where periodontal surgery should not be performed.
HeliMend absorbable collagen membrane is contraindicated in patients
with a known history of allergic responses to collagen.
HeliMend absorbable collagen membrane is contraindicated in patients
who are allergic to bovine-derived products.
Warnings
• Clinicians should use care in screening their patients for any
known allergies to collagen or bovine-derived products.
• Hypersensitivity reactions or immune reactions did not occur
during the clinical trials evaluating the collagen membrane.
All patients in the clinical trial were prescreened by a series of
dermal patch tests for possible sensitivity reaction to the collagen.
No patient prescreened developed a sensitivity reaction.
Additionally, patients were assessed for a potential immune
response to the collagen by evaluating their blood preoperatively
and at several time points postoperatively using an enzyme
linked immunosorbent assay (ELISA). No significant difference was
observed in antibody titers between patients who received the
collagen matrix and those who did not.