PAD III on incathlab: Results, Cases & Significance

Following the excitement of the PAD III RCT results presented at VIVA in November, a rock star faculty of Prof. Gunnar Tepe, Prof. Thomas Zeller, Dr. Arne Schwindt and Dr. Lorenzo Patrone assembled for an incathlab session to discuss the study results and how IVL offers superior vessel preparation over conventional PTA in severely calcified PAD lesions.

During the webinar the results of the PADIII RCT were reviewed, and then followed by an interactive Q&A session and case review, which illustrated how this differentiated data set can be translated into the real world management of calcific lesions.

The webinar replay is available below, we hope you enjoy the content and feel free to reach out to us with any questions you have arising from the topics discussed.

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