Vascupedia Shockweek Day 3: Change Compliance to Change the Game in Endograft Delivery

Calcified hostile access can be an exclusion criteria for endograft delivery and has been associated with both perioperative and long term morbidity and mortality…this is changing! Join the discussion between Drs Bosiers, Fazzini and Isernia and hear how IVL is changing the boundaries in their daily practice for endograft delivery by changing vessel compliance, providing excellent luminal gain and improving patient safety, simplifying the challenges raised by hostile calcified access.

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.