unanswered questions, including which patients are ideal candidates and which protocol and devices are best. Without answers, offering the ED treatment outside research settings is questionable medicine, some urologists say.”
Even so, the article continues, the treatment is widely used in Europe. It is further noted that there are some machines which deliver a very shallow shock wave, which are classified as Class 1 devices and don’t require FDA approval, but are seen by many as largely ineffective. Class 2 devices, which have a great deal more promise, are only FED-approved for clinical trials.
Overall, there are issues of cost, poorly designed studies, confusion over Class 1 and 2 devices and dubiousness regarding the actual safety and efficacy of the treatment, although promising data does indeed exist. A word to the wise: Speak with your healthcare provider or urologist first, especially before purchasing a device online. In other words: Caveat emptor—buyer beware.