Streetinsider.com reported recently that the FDA issued a letter to Medicis, the maker of Dysport®, notifying the company that data presented in the 510(k) application to market the LipoSonix system was insufficient. According to the FDA, Medicis must file a new submission with additional information before LipoSonix can be marketed in the U.S. The FDA's letter to Medicis offered guidance as to the additional information needed to obtain 510(k) clearance. Medicis plans to pursue a meeting with the FDA to present the additional data and to formulate the next steps. The letter from the FDA did not request nor highlight any missing safety data and acknowledged that the agreed primary endpoint of the clinical trial was achieved.
LipoSonix technology uses ultrasound energy to destroy fat cells without harming the skin. The destroyed fat tissue is transported to the liver where it is processed as energy. The treated fat is permanently removed, leaving the patient with a slimmer, more contoured body.
According to Medicis, the LipoSonix system is unlike body contouring technologies because it is highly targeted and has the ability to concentrate energy at specific depths of abdominal fat. By doing so, underlying tissues and non-targeted areas are not damaged.
Results are typically seen in about 8 to 12 weeks. LipoSonix is currently available in Canada, France, Germany, England and Spain.
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