Definition Restore is a multi-purpose, Chorion Free, cryopreserved allograft derived from the amniotic membrane and fluid. Restore is completely natural with components that work to kick start the body’s own healing process.
Recovery The amniotic tissue is donated by healthy mothers at the time of scheduled cesarean section. Expectant mothers submit their past medical and social history which is prescreened by the Medical Director through an intensive and complete medical review and prenatal evaluation, including culturing and serological testing, prior to delivery. The recovery is performed by trained technicians utilizing aseptic technique. No harm is brought to the newborn and parents will still have the option of storing the cord blood, if desired.
Processing Processed at a state-of-the-art, highly accredited tissue bank, the tissue is tested at the time of collection, prior to processing, and again after processing. All unnecessary agents are removed while preserving all other natural occurring materials. The processed materials are then packaged in sterile containers and cryopreserved to protect viability. All processing is performed following the guidelines of the Food and Drug Administration’s Tissue Reference Group (FDATRG). From initial recovery to final packaging, protocols and procedures have been implemented to meet or exceed all applicable industry standards for the use of human tissue products.
Restore Just as the amnion (the innermost layer of the placenta) protects the fetus during development, Restore provides the same protection to injured or traumatized tissue. Restore contains collagen substrates, the full range of growth factors, amino acids, carbohydrates, cytokines, hyaluronic acid, fibroblasts, epithelial cells, and many other cells. Multipotent amniotic cells have proven to be able to differentiate into abiogenic, osteogenic, myogenic, endothelial, neurogenic and hepatic cell lineages. ˡ Orthopedics This membrane is rich with the basic components necessary for tissue regeneration providing an anti-microbial environment, as described in several peer review articles, and anti-inflammatory characteristics with anti- adhesion/anti-fibrotic capabilities, as noted in several studies. To remove the risk of graft host reaction, the chorion, which has been shown to contain maternal antigens, has been removed. This maximizes the potential benefits of amniotic membrane in a variety of medical and surgical specialties. Additionally, the immunologically privileged nature of amniotic membrane has been shown in a multitude of research papers. With these capabilities and characteristics, this allograft may be used in a variety of medical specialties.
Suggested Clinical Applications
- Aesthetic Surgery
- Hair Restoration
- Orthopedics – tendinopathies, tendonitis, fasciitis, soft tissue defects, nerve decompression
- Pain Management – arthritis, chronic pain, carpal tunnel, back pain, shoulder pain
- Podiatry – plantar fasciitis, Charcot
- Wound Care – diabetic ulcers, decubitus ulcers, venous statis ulcers, burns, adhesions
- Aesthetics – surgery, facial fillers, hand rejuvenation, lip enhancement, skin rejuvenation
Packaging For single patient one-time use. Restore is packaged frozen with a locked cap and stored at -65°C – -85°C with a 2 year shelf life.
Directions May be applied topically or injected per physician’s preference. May be diluted to any ration, recommendation is 1:1. Dilution may be achieved with Lidocaine that is preservative free, Marcaine that is preservative free, platelet rich plasma, and normal saline. Do not mix with epinephrine, glucose or glycerol products. A 22-guage needle is recommended.
Please refer to package insert for complete instructions.
FDA Regulatory
- Quality as a 361 HCT/P
- Minimally manipulated (nothing added)
- FDA considers the use of amnion for void fill and soft tissue defects.
- For homologous use