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How IVL Can Enable Transfemoral TAVR Access in Patients With Calcified Iliacs
This episode of Cath Lab Conversations features Dr. Chandan Devireddy, Interventional Cardiologist and Associate Professor, Emory University School of Medicine, and Dr. Karim Al-Azizi, Interventional Cardiologist and Structural Heart Disease Specialist, Baylor Scott & White Health. In this episode, Dr. Devireddy and Dr. Al-Azizi discuss their experience with intravascular lithotripsy, or IVL, for treating calcified iliacs prior to transcatheter aortic valve replacement (TAVR) procedures to preserve transfemoral access as the primary option. You. can also listen to this episode on Spotify and Apple Podcasts!
This episode is sponsored by Shockwave Medical. For more information, visit shockwavemedical.com.
Disclaimers
Dr. Devireddy and Dr. Al-Azizi are paid consultants for Shockwave Medical and opinions expressed are those of the speaker and not necessarily those of Shockwave Medical.
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 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. www.shockwavemedical.com
Please contact your local Shockwave representative for specific country availability and refer to the Shockwave S4 and Shockwave M5 instructions for use containing important safety information.
