This new FDA clearance was issued after a 65-patient prospective multicenter clinical trial demonstrated Renuvion to be safe and effective for delivery of energy under the skin during cosmetic procedures on the neck and chin.
This represents a monumental moment for our Company as we revolutionize the cosmetic surgery market by bringing transformative solutions to our customers. We are excited that Renuvion is now available to surgeons and patients seeking a new, clinically-proven treatment option to improve the appearance of lax, or loose, skin.
Results from IDE Clinical Study #G190152 where Renuvion was the only technology used.
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- Renuvion APR Handpiece is intended for the delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue during open surgical procedures.
- The Renuvion APR Handpiece is indicated for use in subcutaneous dermatological and aesthetic procedures to improve the appearance of lax (loose) skin in the neck and submental region.
- The Renuvion APR Handpiece has general indications for use as well as indications to improve the appearance of lax skin in the neck and submental region only.
- The Renuvion APR Handpiece has not been cleared or approved for use with liposuction or in combination with any aesthetic procedure.
- As with any aesthetic procedure, individual results may vary.
- As with all energy devices there are inherent risks associated with its use.
- Risk associated with the use of the Renuvion APR may include: helium embolism into the surgical site due to inadvertent introduction into the venous or arterial blood supply system, unintended burns (deep or superficial), pneumothorax, temporary or permanent nerve injury, ischemia, fibrosis, infection, pain, discomfort, gas buildup resulting in temporary and transient crepitus or pain, bleeding, hematoma, seroma, subcutaneous induration, pigmentation changes, increased healing time, scarring, asymmetry and/or unacceptable cosmetic result.
- Expected clinical side effects may include discomfort/pain, edema, erythema, ecchymosis, hypoesthesia, touch sensitivity, itching, temporary weight gain, temporary numbness/tingling, subcutaneous nodules or lumps (transient migratory firmness), temporary and/or transient crepitus.
- Please see the instructions for use for more detailed information.