See what Superiority looks like… The First Level 1 Evidence in Calcified PAD

In DISRUPT PAD III, we included the complex, torturous, calcified lesions and risky patients that other studies avoid.  Review the results for yourself and see what superior looks like.

 

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View or Download the Infographic PDF Here

 

 

DISRUPT PAD III Infographic Image

 

 


 

 

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

 

true false See what Superiority looks like… The First Level 1 Evidence in Calcified PAD Click Here To View

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