Is Acoustic Wave Therapy for ED FDA Approved?

A revolutionary treatment called acoustic wave therapy has been developed to treat the root cause of erectile dysfunction (ED). This therapy, which has been approved by the FDA, involves the application of a device to the skin that uses vibrating acoustics or pulsating waves to widen blood vessels and increase blood flow, which is essential for men to perform better. The FDA has approved shock wave therapy as a form of treatment for some medical conditions, and one of its uses is to mitigate the effects of ED. Class 2 shockwave therapy devices are regulated by the FDA and cannot be used outside of a clinical trial. One of the main concerns about shockwave therapy is its cost, as it is still a procedure that is not approved by the FDA.

However, some of its benefits, such as improving blood flow and connective tissue damage, are FDA-approved indications. As shockwave therapy has not yet gained FDA approval, there is no standard treatment for it in relation to ED. On the bright side, it is different from other treatment options for ED, as it offers a possible cure. Doctors may refer to shockwave therapy for ED as low-intensity extracorporeal shock wave treatment (LI-ESWT).A trial revealed that shockwave therapy worked well to restore erectile function in men with mild to moderate vasculogenic ED. Research on the use of shock wave therapy in Peyronie's disease has shown that it can improve penile pain, but not curvature.

The energy from shockwave therapy stimulates the growth of new blood vessels through a process called angiogenesis. Patients who wish to receive shockwave therapy for ED should be encouraged to seek and enroll in clinical trial opportunities. There is a zero-point medical literature that supports the use of this type of shock wave therapy for erection problems. Studies have also shown that low-energy shockwave therapy can improve the response to oral medications for erectile dysfunction. Hatzichristodoulou, who conducted the first prospective placebo-controlled study of shockwave therapy in patients with Peyronie's disease as a medical student about 17 years ago, says there are three placebo-controlled studies available worldwide on this treatment modality and all show that shockwave in Peyronie's disease is effective in treating penile pain, but it does not improve or correct the curvature of the penis. Penile shockwave therapy remains experimental, as it is a relatively new therapy with no long-term data. According to a company spokesman, GAINSWave is a marketing organization that educates consumers and increases public awareness about low-intensity shockwave therapy for erectile dysfunction.