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Shockwave therapies are being adopted more widely in vascular intervention, especially for the management of calcified coronary and peripheral disease. Among these options is Shockwave Medical IVL, a catheter-based approach designed to prepare challenging calcified lesions before stent placement. As adoption expands, clinicians rely on evidence and safety data to guide patient selection and procedural planning.
What is Shockwave Medical IVL and How It Works
Shockwave Medical IVL is a catheter-based system that combines balloon dilation with lithotripsy to treat heavily calcified vascular lesions. Low-pressure balloon inflation delivers sonic waves into the vessel wall, creating microfractures in superficial and deep calcium. This improves vessel compliance and supports effective stent expansion, especially in lesions with significant calcium burden. Indications include calcified coronary stenotic lesions and peripheral arterial disease in vessels such as the iliac, femoral, popliteal, and below-the-knee arteries. The system holds FDA clearance for certain coronary uses and international approvals for peripheral beds.
Procedural workflow often starts with IVUS or OCT to evaluate calcium arc, thickness, and morphology. An IVL balloon is then positioned, pulses are applied at low pressure, and stenting or adjunctive ballooning follows as needed. Predilatation or adjunctive tools may be necessary in tortuous anatomy or nodular calcium.
Clinical Evidence Supporting Shockwave IVL
Coronary evidence begins with feasibility and mechanistic studies. Studies reported high device and clinical success with effective stent delivery in heavily calcified lesions, and optical coherence tomography described circumferential microfracture with compliance gain (Brinton et al., 2019; Kereiakes et al., 2021). Early real-world experience documented angiographic success without major procedural complications in the initial cohort (Wong et al., 2020).
Peripheral data demonstrate benefit in femoropopliteal and iliac vessels. Another study by Tepe et al. (2022) showed superior procedural success versus angioplasty and favorable one- and two-year patency in randomized follow-up. The IVLIAC registry in calcified iliac occlusive disease reported high primary patency with low stenting rates and few complications across four centers (Fazzini et al., 2025).
The literature supports Shockwave IVL as a plaque-modifying modality that improves vessel preparation in coronary and peripheral calcification. Outcomes align with the indications and product information provided for Shockwave Medical IVL systems.
Shockwave Medical IVL Safety Profile
Intravascular lithotripsy has shown a generally favorable safety profile in both coronary and peripheral applications. Procedural risks such as dissection, perforation, abrupt closure, or no-reflow have been reported at low frequencies, and major adverse cardiovascular events occur at rates comparable to other calcium-modifying strategies. An Observational Study indicated modest residual narrowing with measurable lumen gain, supporting its use in heavily calcified disease.
Another Observational Study reported similarly low complication rates, with no significant signal for abrupt closure or distal embolization. Residual stenosis varies by vessel type and calcium severity, and more complex morphologies may require additional energy delivery or adjunctive tools. Longer-term durability and outcomes in higher-risk groups remain less well defined, and further comparative studies are needed to establish its role relative to other modalities.
Introducing SoftWave Therapy: A Broad-Focused Approach to Tissue Healing
While Shockwave Medical IVL is specific to vascular calcification, SoftWave Therapy is a shockwave technology used for many indications. Its distinct, broad-focused shockwave applicator design enables treatment of musculoskeletal conditions, wounds, and connective tissue disorders, extending shockwave therapy into specialties outside of vascular intervention.
Using a patented reflector-based applicator, it delivers broad-focused shockwaves that cover an area up to 12 cm deep and 7 cm wide, reaching both superficial and deep tissues in a single treatment zone. This approach ensures more uniform energy distribution without causing microtrauma, while activating biological processes such as angiogenesis, connective tissue stimulation, modulation of inflammatory pathways, and wound epithelialization.
Supported by medical research, SoftWave Therapy has received multiple FDA 510(k) clearances for connective tissue activation, chronic wound and burn care, and musculoskeletal pain. It is also licensed in Canada for a wide range of soft tissue and regenerative uses. Clinicians in orthopedics, sports medicine, physical therapy, urology, and podiatry have integrated SoftWave into practice to support tissue repair and recovery where vascular IVL is not applicable.
Learn more about the Best Shockwave Therapy Machine for Providers.
Expand Your Clinical Capabilities with SoftWave Therapy
Shockwave Medical IVL has demonstrated strong performance in treating vascular calcification with low complication rates and consistent outcomes. Its role remains tied to vascular applications, but non-vascular conditions such as musculoskeletal injuries, wounds, and soft tissue pain require different approaches.
SoftWave Therapy devices address those needs. Its broad-focused applicator and regulatory clearances make it suitable for soft-tissue repair, chronic wounds, and pain management. Clinicians seeking a versatile system may consider SoftWave when treating a host of conditions alongside vascular care or referrals.
Become a SoftWave Provider or schedule a demo to discover how this technology can support your patients’ recovery and expand your practice.
