Overview
Dr. Omar Davis uses the Diamondback 360® Peripheral Orbital Atherectomy System and a JADE® PTA Balloon to successfully treat the superficial femoral artery and peroneal arteries in a patient with small vessel anatomy.
Dr. Omar Davis uses the Diamondback 360® Peripheral Orbital Atherectomy System and a JADE® PTA Balloon to successfully treat the superficial femoral artery and peroneal arteries in a patient with small vessel anatomy.
The patient is a 64-year-old male with end-stage renal disease, hyperlipidemia, and peripheral artery disease. The patient complained of worsening rest pain and claudication that interfered with daily activities. According to the patient, while both legs were impacted, the right leg was worse than the left.
To determine the levels of stenosis, a bilateral lower extremity angiogram was performed, along with a selective arterial angiogram of the right lower leg.
Access to the left common femoral artery was attained via ultrasound, and a 5 Fr sheath was used for the initial angiogram. Intravascular ultrasound (IVUS) was used to determine the degree of stenosis and vessel sizes. The left superficial femoral artery (SFA) was found to be 80% stenotic. The right anterior tibial artery (ATA) and posterior tibial artery (PTA) were patent. And the right peroneal artery had proximal 90% stenosis.
Dr. Davis selected the Diamondback 360 Peripheral Orbital Atherectomy System with a 1.5 Classic Crown for treatment and performed multiple passes at low, medium, and high speeds through the SFA. The peroneal artery was treated with two passes at low speed due to the size of the vessel, at 2.0 mm, which IVUS confirmed. All stenoses and disease were treated with the Diamondback 360 until the crown could advance and retract smoothly.
The JADE PTA Balloon was selected for additional treatment, and a 014 2.0 mm x 80 mm JADE PTA Balloon was inflated at 12 atmospheres for three minutes. Then a 5.0 mm x 240 mm JADE® PTA Balloon was inflated at 14 atmospheres for three minutes.
Post treatment imaging showed no remaining significant stenosis, and three-vessel runoff was achieved to the right foot.
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 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 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.