Shockwave L6 Now Meets Your Need for Speed
2x Faster Pulsing
We're delighted to share an exciting product improvement of Shockwave L6 Peripheral IVL Catheter. Based on feedback from you, our physician and hospital partners, we've increased the pulsing speed of the Shockwave L6 from one to two pulses per second to mirror the faster pulsing speed you've enjoyed with Shockwave M5+.
Purpose-built to address challenging calcium in large vessels and now pulsing 2x faster, the new Shockwave L6 Peripheral IVL Catheter can continue to serve as a solution to treat your patients with complex, calcified arterial disease.
Appropriate Sizing Optimizes Energy Transfer
Featured Case: Calcified Bilateral Iliacs Courtesy of Dr. Paul J. Foley
63-year-old male, HTN, hyperlipidemia, smoking history, presented with debilitating exertional pain in bilateral thighs/calves, heavily calcified bilateral iliacs.
IVL sizing was based on the preoperative CTA. Shockwave L6 12.0 allowed for appropriate sizing, optimizing IVL's effectiveness.
Two Shockwave L6 12.0 were used to treat bilateral iliac stenoses. After delivering pulses, bilateral 10x39mm GORE VBX were used. Then, the physician post-dilated with a 12.0 balloon.
Dr. Paul Foley is a paid consultant of Shockwave Medical.
Case featured was performed with Shockwave L6 at 1 pulse per second.
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, carotid or cerebral vasculature.
Contraindications—Do not use if unable to pass 0.014″ (M5, M5+, S4, E8) or 0.018″ (L6) 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 thinner–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. https://discover.shockwavemedical.com/ifu
