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Indications, safety, and warnings

CanGaroo BioEnvelope

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a licensed practitioner. Prior to use, please refer to all applicable “Instructions for Use” for more information on Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential Adverse Events, and Operator’s Instructions.

Content  

INTENDED USE/INDICATIONS FOR USE

The CanGaroo® Envelope is intended to securely hold a cardiac implantable electronic device or an implantable neurostimulator to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo® Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices. The implantable neurostimulator devices that may be used with the CanGaroo® Envelope include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators and sacral nerve stimulators.

CONTRAINDICATIONS 

The CanGaroo® Envelope is derived from a porcine source and should not be used in patients with a known sensitivity to porcine material.

WARNINGS AND PRECAUTIONS

  • Only physicians qualified in the placement of CIEDs, such as pacemaker pulse generators or defibrillators, or implantable neurostimulators, such as vagus nerve stimulators, spinal cord neurostimulators, deep brain stimulators or sacral nerve stimulators, should use this device.

  • For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization will compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death.

  • Discard all open or unused product.

  • Device is sterile if the package is dry, unopened and undamaged. Do not use if the package seal is broken.

  • Do not use if storage conditions have not been maintained.

  • The device must be used prior to the “Use-by date” (expiration) date printed.

  • Discard device if mishandling has caused possible damage or contamination.

  • Always handle the device using aseptic technique.

  • Do not use the CanGaroo® with fibrin glue or glue containing glutaraldehyde or other cross-linking agents.

  • The use of the CanGaroo® has not been studied in the pediatric population. As with adult patients, an appropriately-sized CanGaroo® should be selected according to the size of the implantable device.

  • Ensure that the device is properly hydrated prior to suturing. Without proper hydration, the ECM will tear and may not properly retain sutures.

  • Once hydrated, the CanGaroo® Envelope should either be used or discarded. The CanGaroo® Envelope should not be rehydrated and reused.

POTENTIAL ADVERSE EVENTS

The following device-related complications are possible:

  • Allergic reaction to ECM

  • Bleeding

  • Calcification

  • Fever

  • Fibrosis

  • Hematoma

  • Infection

  • Inflammation

  • Seroma

  • Undesired remodeling

Any potential adverse incident involving the CanGaroo® Envelope should be reported immediately.Please report any device-related adverse events to Elutia at +1 470-514-4080.