CMS Confirms Coverage of Kerecis Fish-Skin Products by Medicare
November 14, 2024
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Managing challenging chronic and acute wounds
Shield® is intact fish skin indicated for the management of chronic and acute wounds such as diabetic foot ulcer wounds, pressure ulcers, vascular ulcers, post-Moh’s surgical wounds, and draining wounds commonly treated in physician’s private offices.
The grafts contain fat, protein, elastin, glycans and other natural skin elements, and are fenestrated to allow adequate wound drainage for appropriate wound moisture at the wound bed. Shield products are integrated with a silicone contact layer to protect the wound and for added workflow efficiency.
Shield products are classified as medical devices, and consist of intact fish skin that has been processed using Kerecis’ proprietary EnviroIntact™ method. The products are not subject to the May 31, 2021, FDA 351 regulation.
Shield Standard features a borderless silicone contact layer protecting the 50 mm intact fish skin. It allows for cutting the fish skin and protective silicone to easily fit inside the wound edges and prevents the product from tenting over deeper wounds.
To extend life by supporting the body’s own ability to regenerate.
Shield is super easy to bill using our A code… it’s easy to just stick, bandage, and go! In fact, we can see a couple more patients per day because of the time it saves us!
– Natalie
Physician Assistant in Florida
Optimum application of biologic solutions is dependent on the right environment, including:
Timely Graft Removal. Biologics are highly active in the wound bed, so providers need to prevent the graft from getting stuck in a covering dressing, or being accidentally removed by someone on the care team.
Similarly, providers need to avoid the risk of exudate getting stuck under the graft or dressing: Diabetic Foot Ulcers (DFUs) and other lower extremity wounds may have increased exudate initially when biologic grafts are used, so ensuring the exudate doesn’t get trapped under the graft or dressing is essential for best outcomes.
Time is everything for healthcare providers. Gathering the ideal contact layer or covering dressing is not just time consuming, it can be infeasible in certain situations.
“Shield helps to protect the wound environment while speeding up the preparation and application process…”
Shield use in Wound Management
The Solution: Shield is specially designed to help address these challenges.
A protective “shield” directly on the fish skin graft helps ensure the fish skin does not get stuck in covering dressings, and allow for optimal drapability so it conforms to the wound. The contact layer on Shield Adhesive helps keep the graft in place for the initial placement, then separate from the graft and allow for removal of the silicone without pulling away the graft.
Exudate management is the cornerstone of all good wound care. A silicone without proper exudate control could trap fluids and risk pooling of exudate, infections or hematomas forming. To help reduce this risk, Shield products have specially-designed fenestration lines in the fish skin graft, and extra large pores in the silicone. This allows for maximum fish skin contact with the wound, and maximum drainage while still providing protective coverage.
All included in a single product, Shield helps to protect the wound environment while speeding up the preparation and application process, helping to ensure patients get the best possible outcome from their fish skin graft application.
From the town of Isafjordur in northwest Iceland, Kerecis develops, manufactures, and sells patented fish skin soft tissue regeneration products that have regulatory approval in the United States, Europe and several other jurisdictions.
• Partial and full thickness wounds
• Pressure ulcers
• Chronic vascular ulcers
• Diabetic ulcers
• Trauma wounds, including abrasions, lacerations and skin tears
• Surgical wounds, including donor site/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence
• Draining wounds
The product derives from a from a fish source and should not be used in patients with a known allergy to fish or sensitivity. Note that fish-allergy is not the same as shellfish-allergy. The Shield product also contains silicone and should not be used for patient with silicone sensitivity.
The product and its variations are not available in all countries and may be known under different trade names. Products, product names, indications and claims vary between jurisdictions. Contact your Kerecis representative if you have questions about the availability of Kerecis products in your area.
Always make sure to check with your local health care professional and read the actual printed package information prior to use. Information on this website might not be current and might not be an accurate reflection of current product labeling.
This website is not intended to provide diagnosis, treatment or medical advice. Products, services, information and other content provided on this website, including information that may be provided on directly or by linking to third-party websites, are provided for informational purposes only. Information on this website should not be considered as a substitute for advice from a healthcare professional.
Consult with a physician or other healthcare professional regarding any medical or health related diagnosis or treatment options.
A surgeon must always rely on his or her own professional clinical judgment when deciding whether to use a particular product when treating a particular patient. Kerecis does not dispense medical advice and recommends that surgeons be trained in the use of any particular product before using it in surgery.
The information presented on this website are intended to demonstrate the Kerecis product offerings. A surgeon must always refer to the package insert, product label and/or instructions for use before using any Kerecis product.
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