Prokera

By: Bio Tissue  09-12-2011
Keywords: Storage, healing, Medical Device

ProKera® is class II medical device comprised of cryopreserved amniotic membrane (AmnioGraft®) clipped into a thermoplastic ring set. ProKera® combines the functionality of a symblepharon ring with the biologic actions of cryopreserved amniotic membrane (AmnioGraft®) to create a unique treatment option for corneal and limbal wound management. The ProKera® device configuration enables easy insertion in the office, hospital bedside or following surgical procedures to prevent adhesions while delivering the wound repair and wound healing actions of amniotic membrane.

Indications for use:
ProKera® is used to manage ocular surface healing for a variety of indications including:

  • Corneal epithelial defects
  • High-risk corneal transplants
  • Chemical burns
  • Stevens-Johnson Syndrome

Note: ProKera® should be used cautiously with patients with irregular elevations of the ocular surface (e.g. glaucoma drainage devices)


Sizes:
ProKera® amniotic membrane device is currently available in 1 size. 

The 16 mm device can be used for both children and adults. 


ProKera® Handling:

ProKera® is supplied in an easy to use dual peel pouch. Use sterile smooth forceps or gloves to remove the inner pouch containing the tissue. The clear inner pouch may be introduced to the sterile field. Using sterile scissors, cut below the sealed line of the inner pouch and remove ProKera® using smooth sterile forceps.

Retrieve the device from the sterile, clear inner pouch, using sterile forceps. Please keep in mind the device is very slippery and should be handled carefully.

ProKera® is always manufactured so the stromal side of the tissue will be in contact with the corneal and limbal surface. It is not necessary to trim excess membrane from around the edges of the device.

Corneal defects can be monitored using fluorescein staining and IOP can be tested by using a Tonopen on the device. ProKera® should not be removed until adequate healing has taken place.

ProKera® can remain in the eye up to 30 days. However, ProKera® should facilitate healing in most defects within 5-10 days at which point the membrane in the device will naturally dissolve and the ring set can be removed. 


Storage:
ProKera® is shipped in a temperature controlled container and can be kept in the box until the expiration date and time on the outer container. Once removed from the shipping container, ProKera® can be easily stored in standard refrigeration or freezer devices using the following guidelines:

Storage Time

Storage Device

Storage Temperature

Until expiration date on the tissue package
(media frozen solid)

-80°C Freezer

-85°C to -50°C
(-121°F to -58°F)

1 year after receipt
or until expiration on outer product package,
whichever comes first
(media in liquid state)

Standard home freezer

-49°C to 0°C
(-56°F to 32°F)

3 months after receipt
or until expiration on outer product package,
whichever comes first
(media in liquid state)

Standard home refrigerator

1°C to 10 °C
(33.8°F to 50 °F)

Until expiration date written on outer shipping container

Unopened insulated container

2°C to 20°
(35.6°F to 68°F)

Keywords: Chemical Burns, Corneal Defects, Corneal Transplants, healing, Medical Device, Storage, Temperature Controlled Container, Wound Healing, Wound Repair,

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Overview

These healing activities deliver unique biologic actions which minimize scarring, reduce inflammation, reduce the formation of abnormal blood vessels, and lessen pain. Unlike other preservation methods, cryopreservation retains the natural wound repair and wound healing activities. Bio-Tissue’s and provide unique wound repair and wound healing solutions used to manage.


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