What is Galatea Scaffold?
In the same manner that a trellis works to support the growth of flowers in a garden, a Galatea scaffold encourages the regeneration and growth of a patient's own natural history after surgery. The Galatea scaffold is used to support soft tissue and to reinforce areas that may benefit from additional strength and support.
The Scaffold provides a porous framework or lattice for the patient's own tissue to grow into. Its open pore design encourages tissue ingrowth and healing, reducing the risk of infection. Over time, the lattice bioresorbs, leaving the patient's tissue to provide support.
The Galatea scaffold is a knitted monofilament surgical scaffold made from a completely bioresorbable and biologically derived material called P4HB. It is produced by a safe and natural biological fermentation process, standard to antibiotic and vaccine production, designed for compatibility and minimal inflammatory response. P4HB products have been cleared for sale in the United States and Europe since 2007 and have been used in over a million patients worldwide. The Galatea collection of scaffolds is indicated for use by the FDA for soft tissue reinforcement in plastic and reconstructive surgery.
The Galatea scaffold collection is the first and only contoured design that fits and uplifts the body's natural shape.
How does a Galatea scaffold work?
A Galatea scaffold is implanted during surgery to support soft tissue that would benefit from additional strength and reinforcement. Immediately at work, the Galatea scaffold provides the initial mechanical support to the surgical area, but more importantly it serves as a foundation for tissue regeneration during the healing period. The Galatea scaffold encourages cells to migrate into its pores, allowing collagen to build, and healthy blood vessels to form. During this regeneration and healing process, the Galatea scaffold is naturally absorbed by your body, leaving behind only a strong, healthy tissue to support the primary surgical outcomes. This tissue regeneration begins immediately and results in tissue that is 3-5 times stronger than native tissue.
How long does it take for a Galatea scaffold to natural absorb?
The Galatea scaffold is bioresorbable. It degrades in the human body primarily through hydrolysis. Hydrolysis is a process by which the material is broken down by water. The scaffold loses all of its strength in about 12 months, and is fully absorbed in approximately 18-24 months. The resulting byproduct are carbon dioxide and water, which are natural to the body.
Is the Galatea scaffold a tissue?
Galatea scaffolds are a biological fiber, knitted into an implantable medical device. They are made from neither human nor animal tissue, but rather a bioresorbable polymer that is fully compatible with the body.
Is a Galatea scaffold reimbursable?
Depending on the type of surgery you are having, insurance may be available and offered through a patient's insurance provider to cover costs of surgery and the product. Please speak with your doctor or hospital to understand more.
What is ptosis? Why would a patient need additional reinforcement for a procedure?
Ptosis is the drooping or sagging of the skin usually due to natural aging, excessive weight loss, sun exposure, pregnancy and many other reasons. As we grow older, our skin becomes thinner, and less durable due to a significant loss in collagen and elastin. Therefore, skin may begin to show signs of sagging or skin may feel very loose and no longer provide sufficient mechanical support to withstand the forces imposed upon it.
The Galatea collection of scaffolds can be used to provide soft tissue reinforcement. A Galatea scaffold initially provides much of the strength of the repair and the, over time, tissue grows into the Galatea scaffold and this new tissue provides the long-term support.
Is a Galatea scaffold reimbursable?
Clinical studies show that within 3 years, anywhere from 15-40% of patients undergo another surgery to revise their results. The most commonly cited reason for these re-operations is the re-occurrence of the sagging or drooping.
Physicians have integrated the use of a Galatea scaffold in procedures where patients have weakened tissue and require soft tissue support to achieve the desired surgical outcome. Galatea scaffolds aid in the support, repair, and elevation of weakened tissue and promote strong tissue ingrowth, providing mechanical support to the surgical site. Having soft tissue reinforcement immediately after surgery can be used to help support newly lifted and tightened tissue and potentially prevent re-sagging.
Does a Galatea scaffold interfere with future diagnostic tests such as mammograms?
Clinical data show that there is no visibility of the Galatea scaffold at one year of follow up with ultrasound and mammogram. At that point, the scaffold has integrated well into the tissues and is typically not even detectable by the radiologist.