Enhanced Comfort with Radiesse® (+)
The immediate lift of wrinkles and folds, stimulation of natural collagen production, and lasting results you expect with RADIESSE are now enhanced with 0.3% lidocaine, providing a convenient, pre-mixed option for your practice.
FDA-approved Radiesse® (+) with 0.3% Integral Lidocane is an injectable opaque dermal filler. It contains a small quantity of local anesthetic (lidocaine), shown to reduce pain related to the injection. Radiesse® (+) temporarily adds volume by helping to smooth moderate to severe facial wrinkles and folds, such as nasolabial folds—the creases that extend from the corner of your nose to the corner of your mouth.
Radiesse® (+) Offers:
- Significant pain reduction for enhanced patient comfort
- Convenient, ready-to-use option now pre-mixed with powdered lidocaine
- Excellent rheological properties – a robust filler providing high elasticity (G’) and viscosity
- Controlled delivery with predictable extrusion force using the Terumo® needle
- Demonstrated efficacy and safety profile in phase 3 pivotal trial
The newest member of the RADIESSE family of fillers has just received FDA approval! RADIESSE® (+) with integral 0.3% Lidocaine (“RADIESSE® Plus“) is now available. RADIESSE® (+) provides the immediate lift of wrinkles and folds, stimulation of natural collagen production and lasting results that patients and physicians expect from RADIESSE®, as well as providing patients significant reduction in pain due to the addition of lidocaine1-4.
RADIESSE® (+) injectable implant is an opaque, dermal filler that contains a small quantity of local anesthetic (lidocaine). RADIESSE® (+) is indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds (the creases that extend from the corner of your nose to the corner of your mouth). RADIESSE® (+) is composed of calcium hydroxylapatite (CaHA) microspheres suspended in a water-based gel carrier.
RADIESSE® (+) IMPORTANT SAFETY INFORMATION
Contraindications: RADIESSE (+) injectable implant is contraindicated for patients with known hypersensitivity to any of the components, severe allergies manifested by a history of anaphylaxis, or history or presence of multiple severe allergies; and patients with bleeding disorders.
Warnings: Use of RADIESSE (+) in any person with active skin inflammation or infection in or near the treatment should be deferred until the inflammatory or infectious process is controlled. Do not overcorrect (overfill) a contour deficiency with RADIESSE (+) because the depression should gradually improve within several weeks as the treatment effect of RADIESSE (+) occurs. The safety and effectiveness for use in the lips has not been established.
Precautions: RADIESSE (+) contains calcium hydroxylapatite, radiopaque particles, that are visible on CT Scans and may be visible in standard radiography. Patients using medications that can prolong bleeding, such as aspirin or warfarin, may experience increased bruising or bleeding at the injection site.
Patients should minimize exposure of the treated area to extensive sun or heat exposure for approximately 24 hours after treatment or until any initial swelling and redness has resolved. RADIESSE (+) is for Single Patient Use Only. Do not use if needle is bent. Do not re-shield used needles. Discard needles and syringes as potential biohazards.
Safety of RADIESSE (+) beyond 3 years; in the periorbital area; with concomitant dermal therapies or other drugs or implants; in patients with susceptibility to keloid formation and hypertrophic scarring; in pregnancy, in breastfeeding females or in patients under 18 years has not been established. As with all skin-injection procedures, there is a risk of infection with RADIESSE (+). Patients with a history of herpetic eruption may experience reactivation of herpes.
Adverse Events: The most common serious adverse events with RADIESSE include necrosis, allergic reaction, edema and infection. Common adverse events with RADIESSE are generally mild in nature and short in duration and include bruising, redness, swelling, pain, itching and other local side effects. To report a problem with RADIESSE, please call Customer Service at 1.866.862.1211.
For Instructions for Use Document and complete Patient Information Guide, please click here.
Caution: Rx only.