Axis™ Dermis and Suspend® Fascia Lata

Coloplast’s allograft offerings include Axis Dermis and Suspend Fascia Lata.  Axis and Suspend come in a variety of sizes and can be used for reconstructive procedures to treat pelvic floor repair and urinary incontinence in women.

For ordering information, please call 800.258.3476.

Indications:

Axis Tutoplast Processed Dermis is restricted to homologous use for the repair, replacement, reconstruction or augmentation of soft tissue by a qualified healthcare professional. This includes suburethral placement for stress urinary incontinence procedures and for pelvic floor reconstruction

Donor Screening and Tissue Processing

Axis grafts are processed by RTI Surgical using the Tutoplast process. The donated human tissue utilized was recovered from a donor screened for risk factors associated with infection diseases and medical conditions that rule out donation. Trace amounts of manufacturing residuals may remain after processing. Low dose gamma irradiation is applied terminally to the product to achieve a sterility assurance level of 10-6

Warnings/Precautions:

Axis should only be used by appropriately qualified and properly trained medical practitioners.  Poor general medical condition or any pathology that would limit the blood supply and compromise healing should be considered when selecting patients. Patients should be counseled that there are alternative prolapse and stress urinary incontinence surgical and non-surgical treatments, and the reason for choosing a cadaveric graft procedure should be explained. Physician should also obtain patient consent to surgery with an understanding of the postoperative risks and potential complications of the planned surgery. As with any human tissue implant, it is not possible to guarantee freedom from transmission of infection agents or other adverse reactions.

Adverse Reactions:

Possible adverse reactions include hypersensitivity, allergic or immune response. Other possible reactions include pain, infection, erosion, extrusion, exposure, contracture and procedure failure may occur. Serious adverse tissue responses or infection may require removal of implant.

See the Instructions for Use for detailed information regarding the implant procedure. Warnings /precautions, adverse reactions, prior to using this product.

For further information, call Coloplast Corp at 1-800-258-3476 and/or consult the company website at www.coloplast.us.com.

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician or properly licensed practitioner.

Indications:

Suspend Tutoplast Processed Fascia Lata is restricted to homologous use for the repair, replacement, reconstruction or augmentation of soft tissue by a qualified healthcare professional. This includes suburethral placement for stress urinary incontinence procedures and for pelvic floor reconstruction

Donor Screening and Tissue Processing

Suspend grafts are processed by RTI Surgical using the Tutoplast process. The donated human tissue utilized was recovered from a donor screened for risk factors associated with infection diseases and medical conditions that rule out donation. Trace amounts of manufacturing residuals may remain after processing. Low dose gamma irradiation is applied terminally to the product to achieve a sterility assurance level of 10-6

Warnings/Precautions:

Suspend should only be used by appropriately qualified and properly trained medical practitioners.  Poor general medical condition or any pathology that would limit the blood supply and compromise healing should be considered when selecting patients. Patients should be counseled that there are alternative prolapse and stress urinary incontinence surgical and non-surgical treatments, and the reason for choosing a cadaveric graft procedure should be explained. Physician should also obtain patient consent to surgery with an understanding of the postoperative risks and potential complications of the planned surgery. As with any human tissue implant, it is not possible to guarantee freedom from transmission of infection agents or other adverse reactions.

Adverse Reactions:

Possible adverse reactions include hypersensitivity, allergic or immune response. Other possible reactions include pain, infection, erosion, extrusion, exposure, contracture and procedure failure may occur. Serious adverse tissue responses or infection may require removal of implant.

See the Instructions for Use for detailed information regarding the implant procedure. Warnings /precautions, adverse reactions, prior to using this product.

For further information, call Coloplast Corp at 1-800-258-3476 and/or consult the company website at www.coloplast.us.com.

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician or properly licensed practitioner.

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