Largest Real-World Experience with Shockwave IVL in CLI Patients
At AMP 2022, Dr. Peter Soukas presented the largest set of real-world data on Shockwave IVL in CLI patients. These data include results from patient groups historically not included in other PAD studies, such as Rutherford 6 and dialysis patients, and patients with single or absent vessel run-off. These data show the significant reduction of stenosis post-IVL in these patients, the minimal complications and the consistent results across multiple vessel beds. In this presentation Dr. Soukas shares why these data are important for physicians who treat CLI, and how his calcium modification algorithm has changed over time with IVL.
Watch the data presentation here:
Watch Dr. Soukas’s interview and case examples here:
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All physicians are paid consultants of Shockwave Medical.
Important Safety Information
In the United States: Rx only
Indications for Use – The Shockwave Medical Intravascular Lithotripsy (IVL) System is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. Not for use in the coronary or cerebral vasculature.
Contraindications – Do not use if unable to pass 0.014 guidewire across the lesion • Not intended for treatment of in-stent restenosis or in coronary, carotid, or cerebrovascular arteries.
Warnings – Only to be used by physicians who are familiar with interventional vascular procedures • Physicians must be trained prior to use of the device • Use the Generator in accordance with recommended settings as stated in the Operator’s Manual
Precautions – Use only the recommended balloon inflation medium • Appropriate anticoagulant therapy should be administered by the physician • Decision regarding use of distal protection should be made based on physician assessment of treatment lesion morphology
Adverse Effects – Possible adverse effects consistent with standard angioplasty include: • Access site complications • Allergy to contrast or blood thinners • Arterial bypass surgery • Bleeding complications • Death • Fracture of guidewire or device • Hypertension/Hypotension • Infection/sepsis • Placement of a stent • Renal failure • Shock/pulmonary edema • Target vessel stenosis or occlusion • Vascular complications. Risks unique to the device and its use: • Allergy to catheter material(s) • Device malfunction or failure • Excess heat at target site
Prior to use, please reference the Instructions for Use for more information on indications, contraindications, warnings, precautions, and adverse events. www.shockwavemedical.com
Please contact your local Shockwave representative for specific country availability and refer to the Shockwave S4, Shockwave M5 and Shockwave M5+ instructions for use containing important safety information.