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PHOENIX - Using noninvasive cryolipolysis for fat-layer reduction in the flanks and back fat pads caused no serious adverse events and no reports of skin damage or pigment changes up to 6 months after treatment, results from a large multicenter study showed.
Side effects included "mostly erythema and edema, numbness/tingling, and a little blanching," Dr. A. Jay Burns said at the annual meeting of the American Society for Laser Medicine and Surgery. "Occasionally there was bruising on the treatment site as well, but all side effects resolved by 6 months."
Invented by Dr. Dieter Manstein and Dr. R. Rox Anderson at Massachusetts General Hospital and Harvard Medical School in Boston, cryolipolysis is noninvasive way to cool fat cells to induce lipolysis without damage to other tissue. Pleasanton, Calif.-based Zeltiq currently owns exclusive rights to the technology and markets a cryolipolysis device known as the Zeltiq system.
The Zeltiq system is cleared in the European Union and Canada for noninvasive fat-layer reduction through cold-assisted lipolysis. It is also cleared by the Food and Drug Administration for various applications related to skin cooling during dermatologic treatments, with a pending application for noninvasive fat-layer reduction. The system is available for sale on a limited basis to physicians in the European Union, Canada, and the United States and other selected international markets.
At the meeting, Dr. Burns reported side effect data from two prospective, controlled clinical studies in which researchers at 16 centers used the Zeltiq system to treat 341 patients on their flanks and back fat pads. Efficacy was evaluated by ultrasound, comparison of pre- and post-treatment photographs, and physician assessment. Final follow-up occurred at 6 months or less.
"There were no reports of serious adverse effects, and all side effects were transient," said Dr. Burns, a plastic surgeon in Dallas who is also with the University of Texas Southwestern Medical Center. The most common post-treatment side effect was erythema, followed by hypoesthesia/tingling, edema, bruising, temperature sensation, blanching, and pressure at the treatment site.
PHOENIX - Using noninvasive cryolipolysis for fat-layer reduction in the flanks and back fat pads caused no serious adverse events and no reports of skin damage or pigment changes up to 6 months after treatment, results from a large multicenter study showed.
Side effects included "mostly erythema and edema, numbness/tingling, and a little blanching," Dr. A. Jay Burns said at the annual meeting of the American Society for Laser Medicine and Surgery. "Occasionally there was bruising on the treatment site as well, but all side effects resolved by 6 months."
Invented by Dr. Dieter Manstein and Dr. R. Rox Anderson at Massachusetts General Hospital and Harvard Medical School in Boston, cryolipolysis is noninvasive way to cool fat cells to induce lipolysis without damage to other tissue. Pleasanton, Calif.-based Zeltiq currently owns exclusive rights to the technology and markets a cryolipolysis device known as the Zeltiq system.
The Zeltiq system is cleared in the European Union and Canada for noninvasive fat-layer reduction through cold-assisted lipolysis. It is also cleared by the Food and Drug Administration for various applications related to skin cooling during dermatologic treatments, with a pending application for noninvasive fat-layer reduction. The system is available for sale on a limited basis to physicians in the European Union, Canada, and the United States and other selected international markets.
At the meeting, Dr. Burns reported side effect data from two prospective, controlled clinical studies in which researchers at 16 centers used the Zeltiq system to treat 341 patients on their flanks and back fat pads. Efficacy was evaluated by ultrasound, comparison of pre- and post-treatment photographs, and physician assessment. Final follow-up occurred at 6 months or less.
"There were no reports of serious adverse effects, and all side effects were transient," said Dr. Burns, a plastic surgeon in Dallas who is also with the University of Texas Southwestern Medical Center. The most common post-treatment side effect was erythema, followed by hypoesthesia/tingling, edema, bruising, temperature sensation, blanching, and pressure at the treatment site.
PHOENIX - Using noninvasive cryolipolysis for fat-layer reduction in the flanks and back fat pads caused no serious adverse events and no reports of skin damage or pigment changes up to 6 months after treatment, results from a large multicenter study showed.
Side effects included "mostly erythema and edema, numbness/tingling, and a little blanching," Dr. A. Jay Burns said at the annual meeting of the American Society for Laser Medicine and Surgery. "Occasionally there was bruising on the treatment site as well, but all side effects resolved by 6 months."
Invented by Dr. Dieter Manstein and Dr. R. Rox Anderson at Massachusetts General Hospital and Harvard Medical School in Boston, cryolipolysis is noninvasive way to cool fat cells to induce lipolysis without damage to other tissue. Pleasanton, Calif.-based Zeltiq currently owns exclusive rights to the technology and markets a cryolipolysis device known as the Zeltiq system.
The Zeltiq system is cleared in the European Union and Canada for noninvasive fat-layer reduction through cold-assisted lipolysis. It is also cleared by the Food and Drug Administration for various applications related to skin cooling during dermatologic treatments, with a pending application for noninvasive fat-layer reduction. The system is available for sale on a limited basis to physicians in the European Union, Canada, and the United States and other selected international markets.
At the meeting, Dr. Burns reported side effect data from two prospective, controlled clinical studies in which researchers at 16 centers used the Zeltiq system to treat 341 patients on their flanks and back fat pads. Efficacy was evaluated by ultrasound, comparison of pre- and post-treatment photographs, and physician assessment. Final follow-up occurred at 6 months or less.
"There were no reports of serious adverse effects, and all side effects were transient," said Dr. Burns, a plastic surgeon in Dallas who is also with the University of Texas Southwestern Medical Center. The most common post-treatment side effect was erythema, followed by hypoesthesia/tingling, edema, bruising, temperature sensation, blanching, and pressure at the treatment site.