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

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Indications
HeliMend Advanced 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 Advanced absorbable collagen membrane is contraindicated in
patients who have acute infections or contaminated wounds in the oral cavity.
HeliMend Advanced absorbable collagen membrane is contraindicated in
clinical situations where periodontal surgery should not be performed.
HeliMend Advanced absorbable collagen membrane is contraindicated in
patients with a known history of allergic responses to collagen.
HeliMend Advanced 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.