Stay Calm…Stay Transfemoral

Transfemoral access represents the gold standard for TAVI, with TF access showing a significant reduction in complications and mortality in comparison to alternative access strategies, which add additional complexity and risk to the procedure. Despite the wide acceptance that the transfemoral route provides the safest access for patients, the approach can be hindered by calcified iliac arteries inhibiting delivery of large bore devices by restricting the luminal diameter and reducing vessel compliance. If calcium is not treated adequately prior to TAVI delivery, this can lead to complications such as flow limiting dissection, vessel rupture and unsuccessful delivery of the implant.


Watch as Dr Ole De Backer of Rigshospitalet, Copenhagen walks you through how Intravascular Lithotripsy (IVL) has expanded the boundaries of transfemoral TAVI. During this tutorial series Dr De Backer will provide a detailed explanation of why, how and when IVL can be utilised to improve procedural safety and outcomes for patients undergoing transfemoral TAVI where calcium proves to be an inhibiting factor.


Why Take the Transfemoral Route? IVL Pre TAVI Tutorial Chapter 1 




Unique Mechanism of Action to Treat Calcium: IVL Pre TAVI Tutorial Chapter 2 




The Copenhagen Experience: IVL Pre TAVI Tutorial Chapter 3 




How to Use IVL to Facilitate TF Access: IVL Pre TAVI Tutorial Chapter 4 




IVL in Practice, Patient Selection and Cases: IVL Pre TAVI Tutorial Chapter 5 




In addition to the tutorial series, check out the recent publication from Frontiers of Cardiovascular Medicine, which provides a comprehensive overview from Copenhagen of how IVL is simplifying extremely challenging transfemoral access in TAVI: 




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Important Safety Information


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.


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.


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