Vascupedia Shockweek Day 2: Changing Parameters in CLTI Treatment

Tune in for session 2 of Shockweek on Vascupedia as Dr. Elias Noory treats multiple highly calcified femoropopliteal lesions with IVL. During the session, our expert panel of Drs Lorenzo Patrone, Enrique Alejandre Lafont, Bella Huasen and Thanos Saratzis discuss how IVL can overcome the pitfalls of CLTI treatment by changing vessel compliance to reduce procedural complications. Dr. Noory and the panel also share pearls of wisdom on how to optimize your IVL strategy to get the best outcomes for patients and crack the calcium conundrum.

Watch the video highlights 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.