VIVA is always one of the best peripheral meetings every year, and we’re especially excited this year because we’ve got something new to show you: Shockwave S4.
Shockwave S4 is our IVL catheter designed to treat BTK calcium. It’s got a longer shaft length (135cm), lower profile (5Fr), hydrophilic coating to cross those challenging lesions and offered in smaller balloon diameters designed to treat infrapopliteal lesions. We’ve had the S4 out in Limited Release for a few months, running it through its paces, and we’re very encouraged by what we heard.
One of the best ways to learn about IVL for CLI is to attend our symposium on Wednesday, November 6th, where a Rockstar panel of IVL experts will discuss the application of IVL in multi-level disease, including initial experience with the S4 BTK catheter. Looking forward to seeing you there!
Be sure to drop by our booth to chat and learn more about Shockwave M5, Shockwave S4 and their broad applications across the peripheral vasculature. We’re seeing lots of use in the iliacs, CFA, SFA/Pop and BTK and would love to talk to you about it. We’ve also seen some great cases treating the iliacs in advance of EVAR & TEVAR to avoid access complications.
For those that aren’t going to the meeting, we’re going to be featuring as much content and data presentations as possible on our Twitter handle – @ShockwaveIVL – so stayed tuned for live updates from Vegas.
Remember, What Happens in Vegas…Is Easily Transferable To Your Cath Lab.
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
