Case Courtesy of Dr. Mazin Foteh

69M with HTN, CAD, DM with CLTI and non-healing wound on his right heel. Patient had PAD in all three vessels but the Posterior Tibial was targeted for treatment for wound healing. PT was 100% occlusive throughout various segments of vessel. The patient was non-compressible and had an initial toe pressure of 57. Dr. Foteh used Shockwave E8 as standalone therapy to treat. He used 2.5 mm Shockwave E8  for distal PT and 3.5 mm Shockwave E8 for proximal PT. Post-procedure, the patient had toe pressure of 87 with no complications.

Testimonial

Shockwave E8 delivered tremendously. I am surprised how well it tracked without pre-dil and I love the length and efficient energy through entire balloon.


Dr. Mazin Foteh is a paid consultant of Shockwave Medical.

Peripheral IVL  

Shockwave M5+, Shockwave M5, Shockwave S4, Shockwave L6 and Shockwave E8 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. www.shockwavemedical.com/ifu