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Contraindications
Adherus AutoSpray ET Dural Sealant should not be used in confined anatomical spaces where nerve
compression is of concern. The hydrogel may swell by up to 13% of its size in any dimension.
Warnings
Adherus AutoSpray ET Dural Sealant has not been studied in:
Subjects who require a procedure involving a translabyrinthine, transsphenoidal, or transoral approach, or any
procedure that penetrates the air sinus or mastoid air cells;
Subjects whose dural edge gaps are larger than 2 mm;
Subjects with severely altered renal or hepatic function;
Subjects with an active infection present at the surgical site;
Subjects who have treated or untreated hydrocephalus (e.g., those with devices designed to evacuate
cerebrospinal fluid (CSF) or altered CSF dynamics);
Subjects who have an underlying medical co-morbidity or are on a medication known to interfere with wound
healing (e.g., those with previous intracranial neurosurgical procedure in the same anatomical location,
radiation and chemotherapy treatment, known malignancy, diabetes, steroid toxicity and chronic corticosteroid
use, compromised immune system, or on an anticoagulant agent, aspirin or non-steroid anti-inflammatory
agent);
Subjects with a known allergy to FD&C Blue #1 Dye or FD&C Yellow #5 Dye; or
Subjects who are pregnant or lactating.
Adherus AutoSpray ET Dural Sealant is intended for use as an adjunct to standard methods of dural repair. The
effectiveness of Adherus AutoSpray ET Dural Sealant on other tissue types has not been studied.
Precautions
The Adherus AutoSpray ET Dural Sealant is packaged sterile. Do not use if the trays have been damaged or
opened. Do not re-sterilize.
The Adherus AutoSpray ET Dural Sealant package is intended for single patient use only. Discard all unused and
/ or opened product. Reuse of the device may result in cross contamination which may lead to injury, illness or
death of the patient.
Keep away from sunlight. Do not use if the PEG ester powder is not free flowing.
Use Adherus AutoSpray ET Dural Sealant within 2 hours of reconstituting the crosslinking components. When
tested 8 hours after reconstitution, the resulting sealant swelled a small but statistically significant amount more
when compared to samples reconstituted for 1, 2, or 4 hours.
The extended applicator tip has been designed to conform to the surgical need by the introduction of bends along
the tip length. Apply careful pressure when bending the tip. Do not bend to angles of greater than 90°. Ensure
hydrogel flow once the applicator has been contoured for the surgical need.
The applicator system has a battery life of approximately 2 hours of continuous use.
Prior to application of the Adherus hydrogel, ensure that fluid (cerebrospinal fluid, blood etc.) outflow has been
suspended.
Do not use the Adherus AutoSpray ET Dural Sealant in the presence of flammable anesthetics or flammable
anesthetics with oxidants.
Keep the Adherus AutoSpray ET Dural Sealant device away from strong magnetic fields to avoid possible
interference of RF communication. Magnetic resonance equipment may generate interference with pump
operations.
Do not remove system covers other than the battery door.
Adverse Events
A similar device, Adherus AutoSpray Dural Sealant, containing the same sealant formulation, Adherus Dural
Sealant, was evaluated in 124 investigational patients in a prospective, controlled, multicenter pivotal clinical
study. The incidence and nature of adverse events observed in this patient population was consistent with the
type and complexity of the neurosurgical procedures performed and the co-morbid state of the treated patients.
There were 4 patient deaths among Adherus AutoSpray Dural Sealant subjects and five deaths among control
subjects. The deaths were attributed to the subjects
’
prior condition. The adverse events occurring at a rate of 1%
or higher among the adverse events reported for the subjects treated with Adherus AutoSpray Dural Sealant are
summarized in the table below. There were no unanticipated adverse device effects.
