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LipoSonix Ultrasound System Approved by FDA

September 12th, 2011 Shiv Gaglani Plastic Surgery


The same fundamental technology that allows expectant mothers to see their babies may now be used to help those same mothers lose the extra layers of fat after the pregnancy.

Ultrasound basically relies on the fact that sound waves get propagated, reflected, and absorbed in different ways depending upon the medium, such as fluid (e.g. amniotic or blood; shows up as dark spots) and tissue. If you turn up the intensity and focus those sound waves – a technique appropriately known as high intensity focused ultrasound (HIFU) –  you can actually heat up the tissue and thermally ablate it.  HIFU has already been used to destroy prostate tumors, fix atrial fibrillation, attack uterine fibroids, and deliver drugs across the blood brain barrier.

And now in the US it can also be used for body sculpting, by ablating subcutaneous fat. The FDA just recently approved Medicis‘ Liposonix system in the US for non-invasive waist circumference reduction. We previously covered the Liposonix system in 2007 as well as in August of this year when a clinical study showing the system’s promise was published. Below is a video that demonstrates how the system works:

Here are some details of study results from Medicis’ press release:

The LIPOSONIX system was evaluated in a multicenter, randomized, sham-controlled, single blind study. Treatment with the LIPOSONIX system was shown to be superior to a sham control in reducing waist circumference, meeting the pre-specified primary endpoint of the study. The 59 J/cm2 treatment group demonstrated an approximately 1 cm greater waist circumference reduction as compared to sham. On average, the mean change in waist circumference of approximately 2.6 cm (1 inch) compared to baseline was demonstrated in the 59 J/cm2 treatment group. This could equal one dress or pant size.

The safety of treatment with the LIPOSONIX system was assessed through 24 weeks post-treatment. Safety was assessed by monitoring adverse events, results from a pre-specified battery of blood tests and physical examinations. The adverse events resulting from treatment with the LIPOSONIX system during this study included procedural pain, post-procedural pain, bruising and swelling. These were mostly mild, short-lived in duration and resolved without incident. There were no serious adverse events or unanticipated adverse device effects related to treatment with the investigational device.

Press release: Medicis Announces FDA Clearance of LIPOSONIX(R) System…

Product page: LipoSonix

Shiv Gaglani

Shiv Gaglani is an MD/MBA candidate at the Johns Hopkins School of Medicine and Harvard Business School. In addition to curating the Smartphone Physical (www.smartphonephysical.org), he also contributes regularly to CardioSource World News and Emergency Physicians Monthly. He is interested in developing scalable, tech-based solutions for medicine and education; to this end he is the co-founder of the medical education tech start-up, Osmosis (www.osmosis.org).  More about Shiv: http://about.me/sgaglani

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