Late-Breaking News at VIVA22: Real-World Patients, Real-World Results
In a late-breaking clinical trial session at VIVA22, Dr. Ehrin Armstrong presented the final 1,373 patient cohort data from the Disrupt PAD III Observational Study (OS). PAD III OS represents the largest prospective ‘real-world’ evidence for the treatment of complex, heavily calcified peripheral artery disease. Building on the interim results presented at VIVA21, this larger patient data set reinforces the predictability of IVL and its ability to consistently modify calcium across vessel beds, challenging lesions, and complex patients (CLI, dialysis, and female patients). These real-world outcomes mirror the previously reported PAD III Randomized-Controlled Trial showing that IVL safely and effectively modifies challenging calcium in complex patients.
Check-out the presentation below and hear from Dr. Armstrong on the importance of the largest prospective ‘real-world’ data set in the treatment of heavily calcified PAD.
View the press release here:
Watch the data presentation here:
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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.