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Clinicians evaluating shockwave therapy encounter a range of systems, including the Storz Duolith. While marketing terms can make devices sound interchangeable, the underlying technology, biological engagement, and clinical performance differ significantly. Understanding these distinctions supports more informed decisions about therapeutic value, workflow efficiency, and patient outcomes.
This article provides a clear, evidence-based comparison between SoftWave vs Storz Duolith systems to help providers make informed, clinically grounded decisions.
What the Storz Duolith Machines Claim To Be
The Storz Duolith SD1 Ultra is promoted as a modular extracorporeal shockwave therapy (ESWT) system. Clinics can configure it with a radial module, a focused module, or a combination platform integrating both. The manufacturer describes this modularity as adaptable for orthopedics, urology, and dermatology.
It is marketed as:
- A modular configuration intended for varied therapeutic applications
- Adjustable energy depth and frequency options
- Accessories such as ultrasound guidance or vibration-assisted handpieces
- Claimed use for tendinopathies, erectile dysfunction, chronic pelvic pain syndrome, Peyronie’s disease, and dermatologic conditions
However, in the United States, the FDA 510(k) for the Duolith specifically lists chronic proximal plantar fasciitis as its cleared indication. No broader musculoskeletal or urologic claims appear in the labeling (FDA Summary of Safety and Effectiveness).
Published evidence includes several studies like a single-center RCT in vasculogenic erectile dysfunction, a pilot series in plantar fibromatosis, a prospective randomized trial in chronic diabetic foot ulcers, and a prospective CPPS study. Each reported condition-specific improvements, though all were single-center investigations with limited sample sizes and follow-up durations.
READ MORE: Storz Duolith Machines Compared
SoftWave TRT: A Clinically Validated Broad-Focused System
Growing clinical literature supports the value of broad-focused shockwave therapy for its ability to simultaneously engage both superficial and deep tissues. Unlike modular systems that rely on separate radial and focused components, SoftWave TRT emits parallel, broad-focused shockwaves that penetrate wide and deep, providing consistent and uniform biological activation across multiple layers.
Technology Design
SoftWave’s patented electrohydraulic mechanism uses a parabolic reflector, generating parallel, broad-focused shockwaves that reach both superficial and deep tissue layers at once. Each pulse covers roughly 7 cm × 12 cm, a therapeutic area verified in preclinical and clinical documentation. This wide-field configuration distributes energy evenly, minimizing mechanical stress while maximizing regenerative signaling.
Its plasma-driven spark discharge ensures stable, biologically active waves from the first pulse, while SmartTrode® electrodes automatically maintain optimal output. The closed water system and auto-degas technology keep operation safe and consistent without daily maintenance.
The new SoftWave Gold Li Series continues this engineering lineage from the legacy OrthoGold, UroGold, and DermaGold systems, enhancing energy precision, coverage consistency, and ease of clinical integration for modern regenerative practices.
Regulatory Recognition
SoftWave TRT holds multiple FDA 510(k) clearances for:
- Activation of connective tissue
- Treatment of chronic diabetic foot ulcers
- Treatment of acute second-degree burns
- Temporary pain relief
- Temporary increase in local blood flow
It also carries Health Canada and CE Mark recognition across several specialties, confirming compliance with global safety and performance standards.
Clinical Evidence
SoftWave’s broad-focused electrohydraulic design engages a wide therapeutic field of approximately 7 cm × 12 cm per pulse, and legacy platforms like OrthoGold, UroGold, and DermaGold have been investigated across multiple indications. Some studies include:
- Statistically significant improvements in erectile function and penile hemodynamics were shown in a Goldstein et al., 2024 sham-controlled randomized trial evaluating low-intensity electrohydraulic therapy for men with erectile dysfunction.
- Significant pain reduction and functional improvement for chronic plantar fasciitis were reported in a Fansa et al., 2020 clinical study using medium-intensity unfocused shockwave therapy.
- Accelerated epithelialization and faster wound closure in superficial second-degree burns were confirmed in Ottomann et al., 2012 randomized phase II trial comparing shockwave treatment with standard care.
- Improved wound healing and scar remodeling outcomes in plastic and reconstructive applications were reviewed in Wigley et al., 2022, summarizing multiple clinical trials and confirming a favorable safety profile.
- Reduction in limb volume and symptom severity in late-stage breast-cancer–related lymphedema was documented in Joos et al., 2020, supporting shockwave therapy as a non-invasive adjunct for chronic edema management.
Collectively, these findings demonstrate that SoftWave’s broad-focused shockwave technology promotes effective tissue regeneration and pain relief across diverse clinical indications while maintaining excellent tolerability and safety.
Comparison Overview: SoftWave vs Storz Duolith
| Clinical / Technical Parameter | Storz Duolith SD1 Ultra | SoftWave TRT (Gold Li Series) |
|---|---|---|
| Technology Type | Modular ESWT system with separate focused and radial modules | Integrated broad-focused electrohydraulic system |
| Energy Generation | Electromagnetic (focused) and pneumatic (radial) | Electrohydraulic, plasma-driven spark discharge |
| Energy Range | 0.01–1.24 mJ/mm2 (adjustable per module) | Consistently operates in the regenerative safe zone (0.01–0.19 mJ/mm2) to prevent tissue trauma |
| Therapeutic Field Size | Narrow focal point or limited radial surface | Broad planar field of approximately 7 cm × 12 cm per pulse for wide, uniform tissue engagement |
| Depth of Penetration | Radial: superficial (~2 cm); Focused: deeper targets (~6 cm) | Simultaneous superficial + deep tissue activation within a single pulse (7 cm wide × 12 cm deep) |
| Design Architecture | Modular; requires switching or combining handpieces | Single closed-loop system with SmartTrode® self-adjusting electrodes and auto-degas water management |
| Energy Delivery Consistency | Operator-dependent calibration and manual water maintenance | Automated calibration ensuring consistent, contamination-free wave production |
| Safety Features | Manual water handling and degassing; precision required to avoid overexposure | Closed-loop water circuit, auto-degas, and built-in safety limits that prevent catabolic energy levels |
| Regulatory Scope (U.S.) | FDA cleared for chronic proximal plantar fasciitis | Multiple FDA 510(k) clearances: connective-tissue activation, diabetic ulcers, burns, pain relief, blood-flow increase |
| Clinical Evidence Base | Small, condition-specific studies (ED, plantar fasciitis, CPPS) | Multiple peer-reviewed studies and institutional collaborations (UCLA, Baylor, UCI, Mayo Clinic, Jefferson Health) |
| Comfort / Tolerability | Focused mode may cause discomfort; anesthesia sometimes used | Typically anesthesia-free; broad energy dispersion improves patient comfort |
| Intended Use |
Radial: tendinopathies, soft tissue disorders Focused: Chronic pelvic pain syndrome, Peyronie’s disease, deep tissue treatments |
Multispecialty regenerative system for orthopedic, wound-care, and urologic applications |
Table: Summary of general design, safety, and performance characteristics based on published and regulatory information.
Key Considerations When Evaluating Shockwave Devices
When assessing shockwave platforms for clinical use, it is important to compare core performance criteria, biological reliability, and regulatory validation rather than marketing terminology alone.
- Therapeutic Field Coverage – Broader, uniform fields improve treatment consistency and efficiency.
- Depth of Penetration – Evaluate whether the system engages both superficial and deep tissues in one application.
- Biological Consistency – Independent data confirming uniform acoustic delivery are critical.
- Patient Tolerability – Comfort and minimal downtime enhance adherence to therapy.
- Regulatory and Clinical Validation – Systems with multiple FDA clearances and peer-reviewed data provide higher confidence in safety and efficacy.
- Operational Simplicity – Calibration and workflow efficiency influence long-term usability.
Evaluating these parameters allows clinicians to select a platform that aligns with their specialty focus, patient population, and procedural workflow, whether a narrow focused/radial system or a newer broad-focused electrohydraulic model such as SoftWave TRT’s Gold Li Series.
Clinical Summary Where Storz Duolith Fits and Where Broad-Focused Systems Excel
The Storz Duolith remains a focused/radial ESWT system with published data for select indications such as erectile dysfunction and plantar fasciitis. It represents a condition-specific tool suited for localized therapeutic targets.
In contrast, SoftWave TRT, through its broad-focused, electrohydraulic design, covers larger treatment zones efficiently and reproducibly. Its capacity to activate multiple layers of tissue simultaneously and its multiple FDA clearances makes it suitable for musculoskeletal, vascular, neurologic, wound-care applications, and more. Wi
Clinicians seeking versatility, reduced operator variability, and greater patient comfort will find SoftWave’s technology aligned with the demands of multidisciplinary regenerative care.
Advancing Clinical Outcomes with SoftWave TRT
SoftWave TRT continues to advance regenerative care through validated clinical results and precision engineering. The Gold Li Series, built on more than two decades of scientific refinement, delivers consistent outcomes in orthopedic, wound-healing, and urologic applications. Trusted and chosen by leaders in medicine and champions in collegiate and professional sports like Mayo Clinic, UCSF, Thomas Jefferson University, and Baylor College of Medicine, SoftWave reflects the confidence of the world’s top clinicians.
Join the growing network of physicians integrating this proven technology into their practice.
Become a provider or schedule a demo today to see how SoftWave TRT can expand your clinical capabilities and enhance patient outcomes.
FAQs
What are Storz shockwave machines used for
Storz markets Duolith systems for musculoskeletal, urologic, and dermatologic applications. In the United States their cleared indication is chronic proximal plantar fasciitis after failed conservative care. Use in other conditions is considered off-label.
Is SoftWave a type of focused or radial shockwave
SoftWave is neither focused nor radial. It uses a patented electrohydraulic design that produces a broad-focused planar field covering about 7 cm × 12 cm per pulse. This architecture engages superficial and deep tissues at the same time with uniform energy delivery.
How does SoftWave compare clinically to other ESWT systems
SoftWave holds multiple FDA 510(k) clearances that include activation of connective tissue, increased local blood flow, temporary pain relief, treatment of chronic diabetic foot ulcers, and treatment of acute second-degree burns. The large treatment zone enables efficient coverage and consistent biological activation. Published studies with legacy platforms in orthopedic, wound, and urologic care report improvements in pain, function, perfusion, and healing.
Which device is more comfortable and efficient for patients, SoftWaveTRT or Storz?
Patient experience depends on energy delivery and field size. SoftWave’s broad-focused planar field disperses energy over a larger area, which is typically well tolerated without anesthesia and can reduce session count through wider tissue engagement. Modular focused or radial systems often require more precision targeting and may be less comfortable at higher focal intensities.
