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Allergan Aesthetics, an ABBVie company (NYSE: ABBV), today announced the successful completion of its acquisition of Soliton, Inc. (NASDAQ: SOLY). The addition of Soliton and its technology complements Allergan Aesthetics' portfolio of non-invasive body contouring treatments to now include a proven treatment for the appearance of cellulite.
The RESONIC ™ device initially received U.S. Food and Drug Administration (FDA) 510(k) clearance for the short-term improvement in the appearance of cellulite, and that clearance has now been expanded to long-term improvement up to one year. In recent clinical data submitted to the FDA, RESONIC ™ demonstrated significant improvement in the appearance of cellulite and 97.6% of participants (n=67) found there was good improvement in the appearance of cellulite at 52-weeks post-treatment.
"We welcome the Soliton team to Allergan Aesthetics and the opportunity to offer health care providers and their patients a new, non-invasive option to reduce the appearance of cellulite," said Carrie Strom , President, Global Allergan Aesthetics and Senior Vice President, AbbVie. "In a recent survey of aesthetics consumers, cellulite was cited as a top 5 aesthetic concern, and this technology offers a new approach to treatment."
RESONIC ™ has also received FDA 510(k) clearance for use in conjunction with laser for black ink tattoo removal in Fitzpatrick Skin Type I-III patients. For full safety information, please visit www.RESONIC.com/ISI .
About Allergan Aesthetics
At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consistently provide our customers with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch. For more information, visit www.AllerganAesthetics.com .
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com .
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RESONIC™ IMPORTANT SAFETY INFORMATION
RESONIC Uses
RESONIC™ (Rapid Acoustic Pulse device) is indicated for use as an accessory to the 1064 nm Q-Switched laser for black ink tattoo removal in Fitzpatrick Skin Type I-III patients. The RESONIC device is also indicated for long-term improvement in the appearance of cellulite as supported by clinical data demonstrating treatment benefits up to 1 year of observation. The most common side effects may include mild to moderate temporary redness of the treatment site, mild pain, heat, and pinpoint redness.
General Side Effects and Contraindications
- The most common side effects may include mild to moderate temporary redness of the treatment site, mild pain, heat, and pinpoint redness.
- RESONIC is not for everyone, including those who are pregnant or planning to become pregnant during their treatment course.
- RESONIC should not be used over areas with metal or plastic implants/devices, such as vascular stents or hip or knee implants, or placed over an active skin disorder, including but not limited to rashes, extensive scarring, and psoriasis.
- Tell your doctor about your medical history, including whether you have any active electronic implants, such as pacemakers, defibrillators, cochlear implants, nerve/brain stimulators, or drug pumps, as RESONIC should not be used if you are currently using one of those medical devices.
- You have a medical disorder that would delay the wound healing or immune response, such as blood disorder, diabetes, inflammatory disease, etc.
- Let your doctor know if you have had a surgical procedure within the last 3 months.
- Your results and experience may vary, so it is important to talk to your healthcare provider about whether RESONIC is right for you.
Cellulite-Specific Side Effects & Contraindications
- RESONIC is not recommended if you are a current smoker, or if you have a tattoo or former tattoo at or near the treatment area.
Tattoo-Specific Side Effects & Contraindications
- Other side effects may occur that are related to the laser treatment.
- RESONIC is not recommended if you have undergone prior tattoo removal on the tattoo you want treated. If you have an amateur, self-applied, or layered tattoo, be sure to get approval from your healthcare provider before treating.
- Moderate to heavy tanning on and around the tattoo to be treated should be evaluated and approved for treatment by your healthcare provider.
SOURCE AbbVie
