Erectile Dysfunction Improved Using PiezoWave 2t in Months

PiezoWave 2T (also referred to as PiezoWave2 or PiezoWave2T) is a medical device developed by Richard Wolf and ELvation Medical that uses piezoelectric technology to generate focused low-intensity shockwaves for extracorporeal shockwave therapy (ESWT). It is applied in various fields, including urology for treating erectile dysfunction (ED), particularly the vasculogenic type caused by impaired blood flow to the penis. This non-invasive approach is an alternative to medications like PDE5 inhibitors (e.g., Viagra) or more invasive options like injections or surgery.

Mechanism of Action
The device delivers acoustic shockwaves to the penile tissue, which stimulate biochemical signals that promote angiogenesis (the formation of new blood vessels), enhance tissue repair, and improve circulation and blood flow in the corpora cavernosa and crura of the penis. Unlike point-focused shockwave systems, PiezoWave 2T uses a linear focusing technique called Linear Shockwave Tissue Coverage (LSTC-ED®), which allows for broader and more homogeneous coverage of the target area, potentially increasing effectiveness.

Treatment Protocol
A typical regimen involves outpatient sessions without anesthesia, lasting about 15-33 minutes each. One common protocol includes:
• 4 weekly sessions.
• 4,000 shocks per session at an energy density of 0.16 mJ/mm² and a penetration depth of 10-15 mm.
• Shocks divided equally (2,000 each) between the corpora cavernosa and the crura.
• Total: 16,000 shocks over the course.

Another described schedule is twice-weekly sessions for 3 weeks, followed by a 3-week break, then repeated for another 3 weeks. Patients may continue using PDE5 inhibitors as needed during treatment. The procedure is generally painless, with no reported significant side effects like bruising or discomfort in studies. No downtime is required, allowing immediate return to normal activities.
Patient selection typically targets men with mild to moderate vasculogenic ED (e.g., IIEF-5 scores of 7-21), aged 35-70, in stable relationships, and without contraindications like neurological ED, penile abnormalities, or recent cancer treatments.

Evidence and Efficacy
Clinical data primarily comes from studies on low-intensity ESWT in general, with specific research on PiezoWave 2T showing promising results for vascular ED:

• A prospective, multicentric, placebo-controlled study (n=75 treated, n=50 placebo) using PiezoWave 2T with LSTC-ED® found significant improvements. Average International Index of Erectile Function (IIEF-5) scores rose from 14.4 to 18.6 at 1 month post-treatment, with 81% of patients achieving clinically meaningful success (based on minimal important differences). Satisfaction was high (77% satisfied or very satisfied via Treatment Satisfaction Questionnaire), and 82% would recommend it. Placebo improvements were minimal (10% by IIEF-5). No adverse effects were noted, and long-term follow-ups (up to 2 years) were planned.

• Manufacturer references indicate functional improvements lasting at least 6 months post-treatment. Another cited report discusses long-term patient satisfaction for ED and Peyronie’s disease, though specifics are limited in available summaries.

• Broader reviews and studies on similar Li-ESWT devices report efficacy in mild to moderate ED, with benefits potentially lasting up to a year. A 2025 meta-analysis on ESWT for ED (not specific to PiezoWave) suggested optimal parameters like energy density of 0.09 mJ/mm² and 1,500-2,000 pulses per session for better outcomes, though Piezo Wave's higher density (0.16 mJ/mm²) was effective in dedicated trials.

Overall, evidence supports its use for vasculogenic ED, but results are mixed across broader ESWT research, with some studies showing variable efficacy depending on patient factors like comorbidities (e.g., diabetes, hypertension). More large-scale, long-term studies are recommended to standardize protocols and confirm benefits. It’s not FDA-approved specifically for ED in all contexts, but it’s cleared for general musculoskeletal use and applied off-label or under clinical guidelines in some regions.