Overview
Dr. Omar Davis used the Diamondback 360® Peripheral Orbital Atherectomy System and the JADE® PTA Balloon to successfully treat rest pain and claudication of the left lower extremity.
Patient History
The patient is a 73-year-old male with diabetes, end–stage renal disease, hypertension, hyperlipidemia, and peripheral artery disease. He presented with a history of rest pain and claudication of both lower extremities. He underwent a recent intervention for the right lower extremity, which has improved symptoms and is optimistic that intervention on the left side will also help.
Treatment Summary
The patient’s left groin was sterilized and prepped for access. The left common femoral artery was located with ultrasound assistance and accessed. A 5 Fr sheath was placed. Intravascular ultrasound (IVUS) was then used to assess vessel size, disease, and morphology. Imaging showed 80% stenosis of the left popliteal artery. The left anterior tibial artery (ATA) and posterior tibial artery (PTA) were both 100% stenosed. The peroneal artery was patent. IVUS imaging showed severely calcified plaque throughout.
Dr. Davis selected the Diamondback 360 Peripheral Orbital Atherectomy System (OAS) with a 1.5 Classic Crown. After the IVUS, a ViperWire Advance® Peripheral Guide Wire was inserted. The popliteal artery was treated at low, medium, and high speeds. Then, the left ATA was treated at low, medium, and high speeds after the stenosis was crossed with the guidewire and catheter. After OAS treatment, a 3.0 mm x 240 mm JADE PTA Balloon was inflated in the ATA at 14 atmospheres for three minutes, and a second JADE Balloon was inflated in the popliteal artery at 12 atmospheres for two minutes.
After the completion of the procedure, the patient showed no significant residual stenosis.
Key Takeaways
- Patient presented with 100% left ATA and PTA stenosis, and IVUS showed severe calcified plaque throughout.
- Vessels in left extremity were successfully treated with the Diamondback 360 Peripheral OAS and the JADE PTA Balloon.
Case Study At a Glance
Category
Access
Lesion Location
CSI Device
OAS Crown
Technique / Support
Imaging
Image Gallery
Before Treatment
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Before Treatment
JADE PTA Balloon
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JADE PTA Balloon
Post-intervention
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Post-intervention
Indications and Important Safety Information
JADE® PTA Balloon
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
Diamondback 360® Peripheral Orbital Atherectomy System
Indications Statement: The Diamondback 360® Peripheral Orbital Atherectomy System 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.
ViperWire Advance® and ViperWire Advance® with Flex Tip Coronary Guide Wires
Indications Statement: The Diamondback 360® Coronary Orbital Atherectomy System (OAS) is a percutaneous orbital atherectomy system indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions.
Contraindications: The OAS is contraindicated when the ViperWire Advance® Coronary Guide Wire cannot pass across the coronary lesion or the target lesion is within a bypass graft or stent. The OAS is contraindicated when the patient is not an appropriate candidate for bypass surgery, angioplasty, or atherectomy therapy, or has angiographic evidence of thrombus, or has only one open vessel, or has angiographic evidence of significant dissection at the treatment site and for women who are pregnant or children.
Warnings/Precautions: Performing treatment in excessively tortuous vessels or bifurcations may result in vessel damage; The OAS was only evaluated in severely calcified lesions, A temporary pacing lead may be necessary when treating lesions in the right coronary and circumflex arteries; On-site surgical back-up should be included as a clinical consideration; Use in patients with an ejection fraction (EF) of less than 25% has not been evaluated.
See the instructions for use before performing Diamondback 360 Coronary Orbital Atherectomy System procedures for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential adverse events.
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 and the JADE® PTA Balloon 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.
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Printed from https://csi360.com/case-studies/successful-treatment-of-left-ata-pta-and-left-popliteal-artery-with-the-diamondback-360-peripheral-orbital-atherectomy-system-and-the-jade-pta-balloon/ on 05/30/2023
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