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Revanesse Ultra - P160042

This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.

Product Name: Revanesse Ultra
PMA Applicant: Prollenium Medical Technologies, Inc.
Address: 138 Industrial Parkway North, Aurora, Ontario, Canada L4G 4C3
Approval Date: August 4, 2017
Approval Letter: https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160042a.pdf

What is it? Revanesse Ultra is a dermal filler that can improve the appearance of facial wrinkles and creases, such as smile or laugh lines (nasolabial folds). Revanesse Ultra is a clear, colorless injectable gel that consists of crosslinked hyaluronic acid (HA) made by Streptococcus bacteria.

How does it work? A doctor injects Revanesse Ultra into the facial tissue using an ultrafine needle.

When is it used? Doctors use Revanesse Ultra for patients older than 22 who want to improve the appearance of facial wrinkles folds.

What will it accomplish? Revanesse Ultra may temporarily improve the appearance of the face by adding volume to lessen the visibility of moderate to severe facial wrinkles and folds. In a clinical study of 163 patients, all patients needed one treatment to achieve the best outcome; 68 patient had reached optimal correction or were satisfied with the results at 6 months after one treatment.

Common side effects in the clinical study of Revanesse Ultra showed:

  • Swelling
  • Redness
  • Pain
  • Bruising
  • Headache
  • Tenderness
  • Lump formation
  • Itching

When should it not be used?
Revanesse Ultra is not for patients who:

  • are pregnant or breastfeeding, as the safety of these products for use during pregnancy, or in women who are breastfeeding, has not been studied
  • have a history of hypertrophic scarring or keloid formation
  • have evidence of scars at the intended treatment sites
  • have acne and / or other inflammatory diseases of the skin, such as rosacea, seborrheic dermatitis, and psoriasis,
  • have allergic history including;
    • severe allergic reactions (anaphylaxis),
    • heightened immune responses to common allergens, especially inhaled allergens and food allergens (atopy),
    • allergy to natural rubber latex,
    • allergy to hyaluronic acid products,
    • Streptococcal proteins or have plans to undergo administration of graded doses of allergens (desensitization therapy) during treatment with Revanesse Ultra.
  • have acute or chronic skin disease, such as seborrheic dermatitis or rosacea, in or near the injection sites, or any infection or unhealed wound of the face
  • are under concomitant anticoagulant therapy, antiplatelet therapy, or have a history of bleeding disorders, clotting disorders such as hemophilia or connective tissue disorders such as systemic lupus erythematosus

Additional information (including warnings, precautions, and adverse events): Summary of Safety and Effectiveness Data and labeling are available online.

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