DUBLIN, June 24, 2019 /PRNewswire/ -- Allergan plc (NYSE:
AGN) today announced CoolTone device received FDA clearance for
improvement of abdominal tone, strengthening of the abdominal
muscles, and development for firmer abdomen. CoolTone is also
indicated for strengthening, toning and firming of buttocks and
thighs.
"As the global leader in medical aesthetics and body contouring,
Allergan invests in the ongoing innovation and advancement of safe
and effective non-surgical aesthetic solutions," said Brad Hauser, Vice President, R&D and General
Manager, Body Contouring, Allergan. "We do this by developing
differentiated technology, such as the CoolTone device, that helps
meet the needs of our customers."
Using magnetic muscle stimulation (MMS), CoolTone technology
penetrates into the muscle layers and induces involuntary muscle
contractions. The body responds to these contractions by
strengthening its muscle fibers, resulting in improved muscle
conditioning. Whether targeting abdomen, buttocks or thighs,
CoolTone strengthens, tones and firms the muscles in the treated
area, resulting in a more defined and toned appearance. CoolTone
has 50 percent more magnetic intensity than the leading competitor
(1.35 T versus 0.9 T) at the point of contact.* The clinical
significance of this data has not been established.
"By partnering with Allergan, I can offer my patients additional
options in body contouring solutions," said Dr. Grant Stevens, Founder and Medical Director of
Marina Plastic Surgery, Co-Founder and Chief Medical Officer of
Orange Twist, and Chairman of the USC-Marina Aesthetic Surgery Fellowship.
"CoolSculpting®, for non-surgical fat reduction, is one
of the most requested treatments in my practice, and now I can
introduce my patients to CoolTone for muscle toning, strengthening
and firming of the abdomen, buttocks and thighs."
Allergan is now taking orders for the CoolTone device, and first
units will ship early in the fourth quarter of this year.
*Based on performance testing measuring magnetic field expressed
in tesla (T) over the applicator surface.
About the CoolTone Device
CoolTone uses magnetic muscle stimulation, or MMS technology, to
penetrate into the muscle layers and induce involuntary muscle
contractions. The body's response to these contractions is to
strengthen its muscle fibers, resulting in improved muscle
conditioning. CoolTone is FDA-cleared to strengthen, tone and firm
the muscles of the abdomen, buttocks and thighs and is the latest
addition to the Allergan body contouring portfolio of products. For
more information about CoolTone, visit
www.CoolTonebyCoolSculpting.com.
Indications for CoolTone
The CoolTone device is indicated for improvement of abdominal
tone, strengthening of the abdominal muscles, and development for
firmer abdomen. CoolTone is also indicated for strengthening,
toning and firming of buttocks and thighs.
Important Safety Information for CoolTone
CoolTone should not be used in the head or heart area. CoolTone
treatment is contraindicated in placing the active applicator over
metal or electronic implants/devices in the treatment area like
cardiac pacemakers, cochlear implants, intrathecal pumps, implanted
defibrillators, implanted neurostimulators, drug pumps, and hearing
aids. CoolTone is also contraindicated in placing the active
applicator over menstruating uterus, over areas of the skin that
lack normal sensation, and for patients with fever, malignant
tumor, hemorrhagic conditions, epilepsy, recent surgical procedure
application in the area of growth plate, pulmonary insufficiency,
pregnancy, sensitivity or allergy to latex.
CoolTone should be used with caution in patients with Grave's
disease, active bleeding disorders or seizure disorders.
Women who are close to menstruation may find that it comes
sooner or cramping is increased or intensified with CoolTone
treatments, therefore it is recommended to not undergo treatment
during this time of the month.
Ensure that persons with pacemakers are not present in vicinity
of the device during treatment.
The patient must not be left unattended during treatment.
Adverse effects may include, but are not limited to muscular
pain, temporary muscle spasm, temporary joint or tendon pain, and
local erythema or skin redness.
Consult the CoolTone User Manual for a complete list of
Contraindications, Warnings, Precautions, and potential side
effects. Treatment applications that deviate from the guidelines
are not recommended.
About the CoolSculpting Treatment
CoolSculpting is a non-surgical, clinically proven
treatment that selectively reduces unwanted fat using a patented
cooling technology. Cleared by the FDA, CoolSculpting works by
gently cooling targeted fat cells in the body to induce a natural,
controlled elimination of fat cells without affecting surrounding
tissue, and the treated fat cells are gone for good. In 2019,
CoolSculpting was recognized for the sixth consecutive year by
NewBeauty as a Choice Award winner. Millions of CoolSculpting
treatments have been performed in more than 80 countries.
CoolSculpting is available through a network of
CoolSculpting Centers worldwide. Dermatologists, plastic
surgeons and aesthetic specialists that offer CoolSculpting can be
found at www.coolsculpting.com.
Indications for CoolSculpting
The CoolSculpting procedure is FDA-cleared for the treatment of
visible fat bulges in the thigh, abdomen and flank, along with bra
fat, back fat, underneath the buttocks (also known as banana roll),
and upper arm in patients with a Body Mass Index (BMI) of ≤30 and
in submental and submandibular areas in patients with a BMI of
≤46.2. It is also FDA-cleared to affect the appearance of lax
tissue with submental area treatments.
Important Safety Information for CoolSculpting
CoolSculpting is contraindicated in patients with
cryoglobulinemia, cold agglutinin disease, or paroxysmal cold
hemoglobinuria.
Ask your patient about any medical conditions including recent
surgery, pre-existing hernia, and any known sensitives or
allergies.
During the procedure patients may experience sensations of
pulling, tugging, mild pinching, intense cold, tingling, stinging,
aching, and cramping at the treatment site. These sensations
subside as the area becomes numb. Following the procedure, typical
side effects include temporary redness, swelling, blanching,
bruising, firmness, tingling, stinging, tenderness, cramping,
aching, itching, or skin sensitivity, and sensation of fullness in
the back of the throat after submental or submandibular area
treatment.
Rare side effects may also occur. Paradoxical hyperplasia
(visibly enlarged tissue volume in the treated area) may develop
2-5 months after treatment and requires surgical intervention for
correction.
As with any medical procedure, a consultation should be done by
a licensed healthcare professional to determine if the patient is a
candidate for treatment. Consult the CoolSculpting System User
Manual for a complete list of Contraindications, Warnings,
Precautions, and potential side effects. Treatment applicators that
deviate from the guidelines are not recommended.
About Allergan plc
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a global pharmaceutical
leader focused on developing, manufacturing and commercializing
branded pharmaceutical, device, biologic, surgical and regenerative
medicine products for patients around the world. Allergan markets a
portfolio of leading brands and best-in-class products primarily
focused on four key therapeutic areas including medical aesthetics,
eye care, central nervous system and gastroenterology. As part of
its approach to delivering innovation for better patient care,
Allergan has built one of the broadest pharmaceutical and device
research and development pipelines in the industry.
With colleagues and commercial operations located in
approximately 100 countries, Allergan is committed to working with
physicians, healthcare providers and patients to deliver innovative
and meaningful treatments that help people around the world live
longer, healthier lives every day.
For more information, visit Allergan's website
at www.Allergan.com.
Forward-Looking Statement
Statements contained in this press release that refer to future
events or other non-historical facts are forward-looking statements
that reflect Allergan's current perspective on existing trends and
information as of the date of this release. Actual results may
differ materially from Allergan's current expectations depending
upon a number of factors affecting Allergan's business. These
factors include, among others, the difficulty of predicting the
timing or outcome of FDA approvals or actions, if any; the impact
of competitive products and pricing; market acceptance of and
continued demand for Allergan's products; the impact of uncertainty
around timing of generic entry related to key products, including
RESTASIS®, on our financial results; risks associated
with divestitures, acquisitions, mergers and joint ventures; risks
related to impairments; uncertainty associated with financial
projections, projected cost reductions, projected debt reduction,
projected synergies, restructurings, increased costs, and adverse
tax consequences; difficulties or delays in manufacturing; and
other risks and uncertainties detailed in Allergan's periodic
public filings with the Securities and Exchange Commission,
including but not limited to Allergan's Annual Report on Form 10-K
for the year ended December 31, 2018
and Allergan's Quarterly Report on Form 10-Q for the period ended
March 31, 2019. Except as expressly
required by law, Allergan disclaims any intent or obligation to
update these forward-looking statements.
CONTACTS:
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Allergan:
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Investors:
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Manisha Narasimhan,
PhD
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Media:
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Rodman
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SOURCE Allergan plc