Shockwave IVL for CLTI Patients at CX22
Calcified lesions in CLTI patients pose a number of hurdles for endovascular therapy including acute and sub-acute recoil, flow-limiting dissections and distal embolization. In this presentation from Charing Cross 2022 Dr. Thulasidasan shares how Shockwave IVL has improved his treatment for CLTI patients with low complications and increased durability. Dr. Thulasidasan walks through case examples with IVL in CLTI patients and states how the data supporting IVL backs up what he’s seeing in practice.
Got Five Minutes? Watch Dr. Thulasidasan’s Presentation.
Want to Dive in Deeper? Watch the Full Symposium.
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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.