Vascular News: Clinical & Economic Value of IVL

The COVID-19 pandemic has brought a significant focus on important clinical and economic factors such as hospital length-of-stay and hospital resource utilization.  Hospitals have been forced to innovate in order to maximize the availability of these resources while treating critical patients. 


For some procedures, Shockwave IVL has offered an opportunity to safely, effectively and predictably treat patients, which also minimizes the complications and recovery time that sometimes necessitate longer or more intensive hospital stay.  And in the COVID-19 pandemic, those factors – safety, efficiency, predictability, and getting patients in, out, and back on their feet as fast as possible – are more valuable than ever.


In a new Vascular News supplement, an excellent panel of peripheral interventionalists discuss the clinical and economic value of utilizing Shockwave IVL for a broad range of procedures.


Read the Vascular News supplement here.


Vascular News Supplement Title Page July 2020


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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.


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