keraSys

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keraSys™ bioengineered lamellar patch graft consists of xenogeneic submucosa membrane that has been decellularized and processed to implantable device standards. The material has been engineered to retain translucency and maximize strength and durability. keraSys™ provides the option for a clear graft without the transmission risk of organ donor transplant tissue.


Tissue Quality

Each keraSys™ is processed, sterilized and packaged with proprietary, device-like methods – to ensure consistent, high quality tissue for transplantation.

Design and Usage

  • Low profile for single layer use.
  • Translucent clarity for improved cosmesis in inferior quadrants.
  • Four-layer laminated device is designed for maximum elasticity and structural support.
  • Does not require human allograft licensing.

Simple Storage and Preparations

keraSys™ grafts are provided dehydrated for room-temp storage. keraSys™ must be rehydrated in sterile saline or available ocular irrigating solution.

  • Long shelf-life.
  • Store at room temperature.

Ordering

Precautions

  • Do not re-sterilize. Discard all open and unused portions.
  • Device is sterile if the package is dry, unopened and undamaged. Do not use if the package seal is broken.
  • Discard device if mishandling has caused possible damage or contamination, or if the device is past its expiration date.
  • Ensure that the device is re-hydrated in sterile solution for at least ten minutes prior to suturing in place.
  • Ensure that all layers of keraSys™ are secured when suturing.

Intended Use

The keraSys™ bioengineered Lamellar Patch Graft is intended for implantation to reinforce sclera and aid the reconstruction of the ocular surface.

Contraindications

This device is derived from a porcine source and should not be used for patients with known sensitivity to porcine material.

Sterilization

This device has been sterilized with ethylene oxide.

Utilization and Implantation

Required materials

  • Sterile Forceps
  • A sterile dish with a capacity of at least 10mL
  • Rehydration fluid: at least 5mL of room temperature sterile saline or sterile ocular irrigating solution for each keraSys™ graft.

Simple Storage and Preparations

keraSys™ grafts are provided dehydrated for room-temp storage. keraSys™ must be rehydrated in sterile saline or available ocular irrigating solution.

  • Long shelf-life.
  • Store in a clean and dry location.
  • Store at room temperature.

Utilization guide

  1. Using aseptic techniques, remove the keraSys™ inner pouch from its outer bag, and place the inner pouch in the sterile field.
  2. Open the inner pouch carefully, and aseptically remove the keraSys™ graft with the sterile forceps.
  3. Using aseptic technique, trim the keraSys™ graft to fit the intended site, providing a small allowance for overlap. The device may be trimmed to the desired size more easily prior to rehydration. If this method is selected, be sure to rehydrate the keraSys™ graft prior to suturing into place. See step 6
  4. Place the keraSys™ graft into the sterile dish in the sterile field. (Multiple grafts may be rehydrated simultaneously in the same dish.)
  5. Add to the dish at least 5mL of the rehydration fluid for each graft. Antibiotic and or steroid may be added to rehydration solution.
  6. Allow the keraSys™ grafts to rehydrate for at least ten minutes.
  7. Prepare the graft site using standard surgical techniques.
  8. Using aseptic technique, transfer the keraSys™ graft to the graft site and suture into place, avoiding excessive tension. (Note: Surgical experience indicates that suturing keraSys™ grafts with close tissue approximation produces better outcomes.)
  9. Complete the standard surgical procedure.
  10. Discard any unused portions of the keraSys™ graft.

The relevance of the reimbursement codes depends on indications of use and geographic region.

Please use the hotline or email to determine what the guidelines are for your area.

IOP Reimbursement Hotline:    1.888.700.9005

IOP Reimbursement Email:      support@nmdhealthcare.com

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TK-41015 keraSys Patch Graft (1 x 1.5 cm.) Register to See Pricing
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