CMS Confirms Coverage of Kerecis Fish-Skin Products by Medicare
November 14, 2024
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Kerecis MariGen is intact fish-skin for the management of chronic wounds such as diabetic wounds, pressure ulcers, vascular ulcers, and draining wounds commonly treated in hospital-based outpatient departments.
The Kerecis fish-skin grafts contain fat, protein, elastin, glycans and other natural skin elements and are supplied in multiple shapes, variants and sizes.
The product classifies as a medical device and consist of a full thickness fish-skin that has been processed using Kerecis’ proprietary EnviroIntact™ method. The product is not subject to the May 31, 2021, FDA 351 regulation.
• 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
| wdt_ID | wdt_created_by | wdt_created_at | wdt_last_edited_by | wdt_last_edited_at | SKU | Product Description | Product Sizing | Total Units |
|---|---|---|---|---|---|---|---|---|
| 1 | avista | 27/02/2024 22:00 | hagustsson | 17/07/2024 10:36 | 50200S16B0D | MariGen 16 mm, diameter circular | 16 mm, diameter circular | 2 |
| 2 | avista | 27/02/2024 23:33 | hagustsson | 28/02/2024 14:35 | 50200S00B0D | MariGen 1.75×1.75 cm | 1.75 x 1.75 cm | 4 |
| 3 | avista | 27/02/2024 23:33 | hagustsson | 28/02/2024 14:35 | 50200S01B0D | MariGen 3×3.5 cm | 3 x 3.5 cm | 11 |
| 4 | avista | 27/02/2024 23:34 | hagustsson | 28/02/2024 14:35 | 50200S02B0D | MariGen 3×7 cm | 3 x 7 cm | 21 |
| 5 | avista | 27/02/2024 23:34 | hagustsson | 28/02/2024 14:35 | 50200S05B0D | MariGen 5×7 cm | 5 x 7 cm | 35 |
| 6 | avista | 27/02/2024 23:35 | hagustsson | 28/02/2024 14:35 | 50200S04B0D | MariGen 7×7 cm | 7 x 7 cm | 49 |
| 7 | avista | 27/02/2024 23:35 | hagustsson | 28/02/2024 14:36 | 50200S03B0D | MariGen 7×10 cm | 7 x 10 cm | 70 |
| wdt_ID | wdt_created_by | wdt_created_at | wdt_last_edited_by | wdt_last_edited_at | SKU | Product Description | Product Sizing | Total Units |
|---|---|---|---|---|---|---|---|---|
| 1 | avista | 27/02/2024 22:00 | avista | 27/02/2024 23:50 | 50200P00B0D | MariGen Micro 4 sq cm | 4 cm2 | 4 |
| 2 | avista | 27/02/2024 23:33 | avista | 27/02/2024 23:50 | 50200P01B0D | MariGen Micro 8 sq cm | 8 cm2 | 8 |
| 3 | avista | 27/02/2024 23:33 | avista | 27/02/2024 23:51 | 50200P02D0D | MariGen Micro 19 sq cm | 19 cm2 | 19 |
| 4 | avista | 27/02/2024 23:34 | avista | 27/02/2024 23:51 | 50200P04D0D | MariGen Micro 38 sq cm | 38 cm2 | 38 |
| wdt_ID | wdt_created_by | wdt_created_at | wdt_last_edited_by | wdt_last_edited_at | SKU | Product Description | Product Sizing | Total Units |
|---|---|---|---|---|---|---|---|---|
| 1 | avista | 27/02/2024 22:00 | hagustsson | 28/02/2024 14:57 | 50200F01B0D | MariGen 3×3.5 cm fenestrated | 3 x 3.5 cm, fenestrated | 11 |
| 2 | avista | 27/02/2024 23:33 | hagustsson | 28/02/2024 14:57 | 50200F02B0D | MariGen 3×7 cm fenestrated | 3 x 7 cm, fenestrated | 21 |
| 8 | hagustsson | 28/02/2024 14:58 | hagustsson | 28/02/2024 14:58 | 50200F03B0D | MariGen 7×10 cm fenestrated | 7 x 10 cm, fenestrated | 70 |
| wdt_ID | wdt_created_by | wdt_created_at | wdt_last_edited_by | wdt_last_edited_at | SKU | Product Description | Product Sizing | Total Units |
|---|---|---|---|---|---|---|---|---|
| 1 | avista | 27/02/2024 22:00 | hagustsson | 30/09/2024 14:57 | 50200N11B0D | MariGen Expanse 7×8 cm meshed 2:1 | 7 x 8 cm | 56 |
| 2 | avista | 27/02/2024 23:33 | hagustsson | 30/09/2024 14:58 | 50200N13B0D | MariGen Expanse 8×10 cm meshed 2:1 | 8 x 10 cm | 80 |
| 3 | hagustsson | 27/09/2024 09:31 | hagustsson | 27/09/2024 09:31 | 50200N42B0D | MariGen Expanse 2×2 cm meshed 2:1 | 2×2 cm | 4 |
| 4 | hagustsson | 27/09/2024 13:27 | hagustsson | 27/09/2024 13:27 | 50200N43B0D | MariGen Expanse 3×3 cm meshed 2:1 | 3×3 cm | 9 |
| 5 | hagustsson | 27/09/2024 13:28 | hagustsson | 27/09/2024 13:28 | 50200N44B0D | MariGen Expanse 4×4 cm meshed 2:1 | 4×4 cm | 16 |
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 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 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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