This is a half-baked system that is definitely not safe, and is of questionable efficacy. Johns Hopkins Doc Hugh Calkins, who served as pitchman for the device, has a long history of putting profits before public safety. His earlier mercenary efforts on behalf of industry are chronicled here: http://collateral-damage.net. Greed and corruption of the sort demonstrated by Calkins in the evolution of this procedure is at the heart of what’s wrong with American medicine.