Overview
Dr. Amit Srivastava used the 2.00 Max Crown and JADE® PTA Balloon Catheter via radial artery access to successfully treat Critical Limb Ischemia of the left lower extremity in a 93-year-old patient.
Dr. Amit Srivastava used the 2.00 Max Crown and JADE® PTA Balloon Catheter via radial artery access to successfully treat Critical Limb Ischemia of the left lower extremity in a 93-year-old patient.
The patient was a 93-year-old male with a past medical history significant for Peripheral Arterial Disease. History includes below-the-knee amputation and left fem-pop bypass grafting, hypertension, hyperlipidemia, and prior tobacco abuse. He was status post-intervention for occlusion of his left fem-pop bypass graft approximately six months prior to presentation. He presented with a nonhealing, necrotic left great toe wound. This was refractory to conservative care and wound care. He was compliant with clopidogrel monotherapy and compliant with wound care management. Given the rapid progression of his left great toe wound, he presented to the hospital for further evaluation and management.
On examination, the patient had a non-palpable left common femoral pulse with strongly palpable right common femoral pulse. Pedal pulses were nonpalpable in the left lower extremity with a necrotic great toe. Successful treatment of the common femoral artery lesion was accomplished using the Diamondback 360® Peripheral Orbital Atherectomy System — Exchangeable Series and the New 2.00 Max Crown.
Given this constellation of findings, the decision was made for transradial angiography and intervention to minimize procedural access site risk. The right radial artery was accessed under ultrasound guidance, and a 119 cm sheath was advanced into the left external iliac artery. Angiography confirmed occlusion of the left common femoral artery with widely patent left fem-pop bypass graft and single vessel runoff to the left foot via the peroneal artery. The tibioperoneal trunk also had severe (80-90%) stenosis.
The total occlusion was successfully crossed with a crossing catheter and guidewire. Once true luminal placement was confirmed in the left fem-pop bypass graft via injection through the transit catheter, a ViperWire Advance® Peripheral Guide Wire was advanced into the distal left peroneal artery. The Diamondback 360® Peripheral Orbital Atherectomy System – Exchangeable Series with a 2.00 Max Crown was selected and crossed the total occlusion at low and medium speeds with unobstructed reconstitution of flow into the left lower extremity. This was followed by prolonged 3 mm angioplasty to the left tibioperoneal trunk and prolonged 6 mm balloon angioplasty to the fem-pop bypass graft as well as the left common femoral artery with JADE® Non-Compliant PTA Balloon Catheters. Excellent procedural results were noted with brisk runoff to the left foot via the peroneal artery, which reconstitutes dorsal as well as plantar flow into the left foot with excellent digital perfusion. The left common femoral artery was noted to be widely patent without residual flow-limiting stenosis.
The patient underwent subsequent amputation of the left great toe, and the surgical site healing was excellent.
The JADE PTA Balloon Catheter is manufactured by OrbusNeich Medical Company Limited.
Distributed by CSI.
Caution: Federal law (USA) restricts the sale of these devices to sale by, or on the order of, a physician.
JADE is a registered trademark of OrbusNeich Medical Company Limited. ©2022 OrbusNeich Medical Company Limited or its affiliates. G-70-1906 Rev01
Indications Statement: The Diamondback 360® Peripheral Orbital Atherectomy System – Exchangeable Series is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy. The OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The system is a percutaneous orbital atherectomy system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.
Contraindications: The Systems are contraindicated for use in coronary arteries, bypass grafts, stents, or where thrombus or dissections are present.
Adverse Events: Although the incidence of adverse events is rare, potential events that can occur with atherectomy include: pain, hypotension, CVA/TIA, death, dissection, perforation, distal embolization, thrombus formation, hematuria, abrupt or acute vessel closure, or arterial spasm.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
Results may vary.
Suggestions on case studies offered by the physician are based on their experience using the Diamondback 360® Peripheral Orbital Atherectomy System – Exchangeable Series and are their opinion. Medical decisions for your patients are to be based upon their condition and your medical judgment. CSI does not recommend or endorse any particular course of treatment or medical choice. Before using any medical device, including those demonstrated or referenced in this case study, review all relevant Instructions for Use with particular attention to the indications, contraindications, warnings and precautions, and steps for use of the device.
CSI, Diamondback, Diamondback 360, and ViperWire Advance are registered trademarks of Cardiovascular Systems. ©2022 Cardiovascular Systems, Inc. All Rights Reserved.
OrbusNeich and Jade are registered trademarks of OrbusNeich Medical Company Limited. ©2022 OrbusNeich. All rights reserved. G-70-2163