Iliac artery calcium is particularly difficult to manage both safely and effectively with most endovascular tools and often requires costly and risky adjunctive procedures or surgical intervention, increasing morbidity and cost.
Check out these videos from EVToday where an all-star lineup of Drs. Frank Arko, Ehrin Armstrong, Mazin Foteh and Andrew Holden discuss the clinical and economic value of using Shockwave IVL in aortoiliac occlusive disease for both PAD and EVAR/TEVAR access!
The Challenges of Iliac Calcium with Dr. Frank R. Arko III
Dr. Frank R. Arko III presents, “Managing Calcification in Aortoiliac Disease and Challenging EVAR/TEVAR Access with IVL: A Vascular Surgeon’s Perspective.”
Intravascular Lithotripsy and its Application in Iliac Disease with Dr. Ehrin J. Armstrong
Dr. Ehrin J. Armstrong presents, “Introduction to Shockwave Intravascular Lithotripsy and its Application in Iliac Disease.”
IVL Experience in EVAR & TEVAR Access with Dr. Mazin I. Foteh
Dr. Mazin I. Foteh presents, “Treatment of Calcified Iliac Stenosis using Intravascular Lithotripsy to Facilitate Percutaneous Aortic Intervention.”
IVL Experience in Iliac Occlusive Disease with Prof. Andrew Holden
Prof. Andrew Holden presents, “Shockwave Intravascular Lithotripsy in Aorto-Iliac Occlusive Disease (AIOD).”
For more great cases and discussions like these, follow @ShockwaveIVL on Twitter!
Important Safety Information
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
Indication 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