GRAFTJACKET® Xpress Flowable Soft Tissue Scaffold (FSTS)
GRAFTJACKET® Xpress Flowable Soft Tissue Scaffold (FSTS) is a micronized flowable acellular collagen scaffold for tissue regeneration in deep tunneling or tracking wounds.
• Easy application to tunneling wounds via syringe with flexible applicator tip
• Conforms to the shape of the wound and fills deep, tunnel-like wounds
• Supports cellular repopulation and revascularization by host tissue
• May minimize the need for more extensive surgical intervention
• Single application may minimize repeated patient visits
• Replaces damaged or missing tissue with 'like' tissue
• Flowable human acellular dermis
• Requires one application in most cases
• Two year shelf life
GRAFTJACKET® Xpress FSTS supports the body's repair of damaged or inadequate integumental tissue, such as deep dermal wounds or diabetic ulcers.
Each package of GRAFTJACKET® FSTS is intended for use in one patient, on a single occasion.
GRAFTJACKET® FSTS is contraindicated for use in any patient who is sensitive to polysorbate 20 or any of the antibiotics listed on the package.
Because of the particle size, GRAFTJACKET® FSTS should not be used in the periocular, forehead or glabellar areas.
Processing of the tissue, laboratory testing, and careful donor screening minimize the risks of the donor tissue transmitting disease to the recipient patient. As with any processed donor tissue, the GRAFTJACKET® Xpress FSTS cannot be guaranteed to be free of all pathogens. No long-term studies have been conducted to evaluate the carcinogenic or mutagenic potential or reproductive impact of the clinical application of the GRAFTJACKET® Xpress FSTS.
Do not re-use GRAFTJACKET® Xpress FSTS
Do not sterilize GRAFTJACKET® Xpress FSTS.
Do not use GRAFTJACKET® FSTS if the foil pouch is perforated or torn. A damaged pouch may result in degradation or contamination of the product.
The foil pouch that contains the GRAFTJACKET® FSTS is not sterile. Do not place the foil pouch in the sterile field.
It is the responsibility of the physician to determine the appropriate amount of GRAFTJACKET® FSTS for each application.
Poor general medical condition or any pathology that would limit the blood supply and compromise healing, as well as nonvascular surgical sites, should be considered when selecting patients for implanting GRAFTJACKET® FSTS as such conditions may compromise successful implantation. Additionally, users should assess the appropriateness of using the GRAFTJACKET® FSTS in patients diagnosed with autoimmune connective tissue disease.
Use of GRAFTJACKET® FSTS is limited to specific health professionals (e.g., physicians and/or podiatrists).
Whenever clinical circumstances require implantation in a site that is contaminated or infected, appropriate local and/or systemic anti-infective measures should be taken.
DO NOT USE the GRAFTJACKET® FSTS if prior to rehydration it is not uniformly white to buff in coloration.
DO NOT USE the GRAFTJACKET® FSTS if it has discolored. Unused or expired product should be discarded according to local institutional requirements.
Potential adverse effects which may result from placement of an implant or graft include, but are not limited to the following: wound or systemic infection; hypersensitive, allergic or other immune response; rapid resorption of graft material; and disease transmission.
Adverse outcomes potentially attributed to GRAFTJACKET® FSTS must be reported promptly to LifeCell Corporation.
Upon receipt, refrigerate at 1°C-10°C (34°F-50°F).
|Assigned HCPCS code||●|
|Shelf life greater than 2 years|
|Shelf life limited|
|Indicated for acute wounds|
|Indicated for chronic wounds|
|Indicated for diabetic ulcers||●|
|Indicated for pressure ulcers|
|Indicated for surgical wounds|
|Indicated for third-degree burns|
|Indicated for venous ulcers|
|Contact manufacturer for usage guidelines|
|Educational Material Available||●|
|Free Samples/Trials Available||●|
|Published Clinical Article Available|
Reconstitute with sterile saline. Attach the flexible applicator tip and apply GRAFTJACKET® Xpress FSTS directly into the debrided, clean wound. GRAFTJACKET® Xpress FSTS fills the irregularly shaped wound.
Using the 3cc syringe and 23-gauge needle provided in the accessory kit, aseptically aspirate the appropriate volume of sterile normal saline (0.9% sodium chloride, not included in this package) into the syringe.
Attach the syringe adapter to the 3cc syringe and advance plunger to fill the syringe adapter. Set the 3cc syringe aside.
Remove the 5cc syringe containing GRAFTJACKET® Xpress FSTS powder from the foil pouch. Do not remove the Luer cap. Pull the plunger back approximately 1cc and hold. Tap the syringe until the product powder is disrupted. Unscrew and remove the Luer cap.
Connect the 5cc syringe to the 3cc syringe using the syringe adapter. Slowly transfer the saline from the 3cc syringe into the 5cc syringe.
While holding the 3cc syringe in one hand, tap the 5cc syringe containing GRAFTJACKET® Xpress FSTS and saline against the palm of the opposite hand. Continue until GRAFTJACKET® Xpress FSTS is completely wetted (the color will change from white / buff to cream when wetted).
Slowly expel trapped air from the 5cc syringe by gently loosening the 3cc syringe from the adapter and
depressing the 5cc syringe plunger. Ensure the air is expelled from the 5cc syringe.
Retighten the syringe assembly.
To mix, push the wetted material back and forth from one syringe to the other for about one minute. It is normal that the material begins to thicken. Transfer all material to the 3 cc syringe and disconnect from the adapter.
Remove the needle from the 18-gauge plastic OPTIVA® I.V. catheter. Dispose of the needle. Attach the plastic catheter to the 3cc syringe. The GRAFTJACKET® Xpress FSTS is now ready for application.
GRAFTJACKET® FSTS is supplied as a dried, acellular dermal particulate in a syringe. Each package contains one 5cc syringe with the GRAFTJACKET® FSTS packaged in a foil pouch. The GRAFTJACKET® FSTS package includes standard disposable supplies to facilitate rehydration and delivery. These include: a sterile 3cc syringe, a sterile 23 gauge needle, a sterile 1-1/4 18-Gauge OPTIVA® I.V. catheter, and a sterile syringe adapter with double female luer locks.
Acelity leverages the strengths of Kinetic Concepts and Systagenix Wound Management to provide a trusted and complementary portfolio of advanced wound therapeutics for customers and patients in more than 90 countries worldwide.