With the number of bogus remedies and treatments floating around, claiming to provide relief for various ailments, the FDA really has its work cut out for it. I mean, can you imagine trying to wade through the swamp of snake oil that exists out there just to find the stuff that isn’t a total scam? One particularly interesting new device that just gained FDA approval is a historic milestone, being the very first treatment device that uses shock waves to promote healing.
Sanuwave’s Dermapace system is a handheld want attached to a larger central unit that work in tandem to expedite healing in patients who suffer from diabetic foot ulcers. The gadget is the first of its kind to score FDA approval and was approved through the FDA’s “de novo premarket review pathway,” which helps to push new technologies through to market in cases where no similar devices have preceded it.
Sanuwave put the Dermapace system was put through a pair of double-blind studies to prove its effectiveness, using a total of 336 patients as test subjects. Patients were given the typical treatment for their foot ulcers, which included wound dressings and upkeep, along with either a fake shock wave therapy with a non-working system or the Dermapace treatment. Patients who received the real shock wave therapy demonstrated a significantly higher wound closer rate vs their peers who received the fake treatment (44% vs 30%).
The system appears to work as advertised, and the FDA gave it the thumbs up to be marketed as an optional treatment for diabetic foot ulcers, but shock wave therapy itself is hardly new. Similar devices have been used in veterinary medicine for some time, and pet owners can often opt to have surgery wounds on their animals treated with shock wave instruments in order to speed up the healing process by promoting the growth of blood vessels in tissue.
Of course, scoring approval for the devices to be used on humans is an entirely different ballgame, and Sanuwave has taken the lead in the field for the moment. With the Dermapace system now officially blessed by the FDA, it’s likely that similar systems will follow in its footsteps.