Overview
Dr. Omar Davis used Diamondback 360® Peripheral Orbital Atherectomy System and JADE® PTA Balloons via the superficial femoral artery access to successfully treat a patient with rest pain and recurrent ulcers in their right lower extremity.
Dr. Omar Davis used Diamondback 360® Peripheral Orbital Atherectomy System and JADE® PTA Balloons via the superficial femoral artery access to successfully treat a patient with rest pain and recurrent ulcers in their right lower extremity.
The patient is a 54-year-old male with end-stage renal disease, diabetes, and hypertension. He sought care due to rest pain and recurrent ulcers in his lower right extremity.
The patient’s left groin was sterilized and prepped for access. Using ultrasound guidance, the left femoral artery was located and accessed. A 5 Fr sheath was inserted and then used for the initial angiogram runs. Intravascular ultrasound was used to gather information about vessel size, stenosis, and disease morphology.
The angiogram showed 80% stenosis in the superficial femoral artery (SFA); the right anterior tibial artery (ATA) showed 60% stenosis at the ankle; the right posterior tibial artery (PTA) showed 100% proximal occlusion and 90% occlusion at the ankle into the plantar artery. The peroneal artery was not visible.
Dr. Davis selected the Diamondback 360 Peripheral Orbital Atherectomy System (OAS) with a 1.5 Classic Crown. Dr. Davis performed multiple passes through the SFA at low, medium, and high speeds. All disease was treated within the approved device best practices until the device crown could advance and retract smoothly. After the OAS treatment of the SFA, a .014 6.0 mm x 150 mm JADE PTA Balloon was placed and inflated at 10 atmospheres for three minutes.
The Diamondback 360 was then used to treat the proximal PTA using passes at low, medium, and high speeds. The device was also used for multiple passes in the distal PTA at low speed only due to vessel size. After OAS treatment, a 014 2.0 mm x 120 mm JADE PTA Balloon was used in the distal percutaneous transluminal angioplasty. It was inflated at 12 atmospheres for three minutes. Then a .014 3.0 mm x 240 mm JADE PTA Balloon was inflated in the proximal PTA at 12 atmospheres for three minutes.
Post-OAS and PTA arteriograms confirmed the success of the treatment, and no residual stenosis was noted.
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 and the Diamondback 360® Peripheral Orbital Atherectomy Systems 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.