MedSurge, Osyris win FDA clearance for varicose vein devices; launch laser lipolysis seminars
SEPTEMBER 5, 2008 -- The US FDA has granted 510(k) clearance for the Exotherme and Endotherme 980 devices -- for laser surgery of spider veins and saphenous veins -- to Osyris (Hellemmes, France) and MedSurge Advances (Dallas, TX). Both medical instruments run off the same platform as Lipotherme, the companies' laser lipolysis tool that is the subject of a seminar series. The seminars start tomorrow in New York and Las Vegas, and travel to Dallas, Lakewood, NJ and Atlanta.
SEPTEMBER 5, 2008 -- The US Food and Drug Administration (FDA) has granted 510(k) clearance for the Exotherme and Endotherme 980 laser instruments -- for treatment of spider veins and greater/superior saphenous veins in the legs -- to partner companies Osyris (Hellemmes, France) and MedSurge Advances (MSA; Dallas, TX). Both medical devices run off the same platform as Lipotherme (FDA approved in April), the companies' laser lipolysis ("fat splitting") liposuction-alternative product that is the subject of a seminar series this month. The one- and two-day body-shaping seminars start tomorrow in New York and Las Vegas, and will travel to Dallas, TX; Lakewood, NJ; and Atlanta, GA later this month.
The Endotherme and Exotherme products compete with devices offered by Biolitec and Diomed, which Biolitec acquired earlier this year. Endotherme treats greater saphenous/superior saphenous leg veins, while Exotherme treats teleganectasia (spider leg veins).
As their names suggest, Exotherme 980 and Endotherme 980 incorporate 980 nm continuous wave diode lasers, which can be adjusted from 6 watts to 25 watts of power. That same technology is the basis for Lipotherme, featured in MSA's one- and two-day laser lipolysis seminars that aim to help physicians integrate the body-sculpting laser lipolysis procedure into their current practice or medical spa.
The seminar schedule is:
New York, NY Sept 6
Las Vegas, NV Sept 6-7
Dallas, TX Sept 13-14
Lakewood, NJ Sept 20-21
Atlanta, GA Sept 27-28
For details, call 214-540-3343 or visit MSA's website, www.medsurgeadvances.com.
The 980 laser platform is "a highly adaptable technology that allows physicians to easily switch from performing laser lipolysis to treating greater saphenous veins and spider leg veins simply by changing hand pieces and Smartcards, the "brains" behind the technology," says Scott Day, MedSurge Advances' chairman, CEO and president.
MedSurge Advances, which calls itself the U.S.'s largest independent provider of aesthetic medicine products and services to physicians, has exclusive rights to market the Exotherme, Endotherme, and Lipotherme in the US. Osyris, manufacturer of lasers for healthcare and industrial applications, developed the technology and has been manufacturing and marketing it in Europe. The privately held partners, which have a shared ownership agreement, work together on product development.