Overview
Dr. Omar Davis used the Diamondback 360® Peripheral Orbital Atherectomy System and JADE® PTA Balloons to successfully treat the right lower extremity.
Dr. Omar Davis used the Diamondback 360® Peripheral Orbital Atherectomy System and JADE® PTA Balloons to successfully treat the right lower extremity.
The patient, an 83-year-old male, presented with bilateral lower extremity claudication and rest pain. He had recently undergone atherectomy and angioplasty of his left anterior tibial artery, resulting in significant symptom relief. However, symptoms persisted in the lower right extremity, and he sought treatment.
Access via the left groin was prepared; the left common femoral artery was located with ultrasound guidance and accessed. A 5 Fr sheath was used for the initial arteriogram. Due to the recent procedure on the right lower extremity, contrast media was rationed and monitored. The 5 Fr sheath was removed and replaced with a 90 cm 6 Fr sheath.
The arteriogram showed 100% occlusion of the right anterior tibial artery (ATA), with collateral flow and reconstitution at the ankle. Both the right posterior tibial artery (PTA) and peroneal artery showed 90% distal stenosis.
Dr. Davis selected the Diamondback 360 Peripheral Orbital Atherectomy System with a 1.5 Classic Crown and a ViperWire Advance® Peripheral Guide Wire. Attempts to cross the chronic total occlusion of the ATA were unsuccessful, causing the wire to go extravascular in these attempts. The PTA was wired successfully and was treated with the 1.25 Classic Crown at low, medium, and high speeds. Then the PTA was treated with a 014 2.5 mm x 240 mm JADE PTA Balloon inflated at 12 atmospheres for three minutes. After the treatment, no significant residual stenosis was noted.
The 1.25 Diamondback 360 Classic Crown was used, and the ViperWire Advance Peripheral Guide Wire was retrieved and redirected down the right peroneal artery, crossing the stenosis. Multiple passes were made at low, medium, and high speeds. Then the right peroneal artery was treated with a 014 3.0 mm x 120 mm JADE PTA Balloon. The balloon was inflated at 14 atmospheres for three minutes, after which there was no significant residual stenosis found.
Final imaging, as well as the comparison of pre- and post-operative images, showed no significant residual stenosis.
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.
The JADE PTA Balloon is a registered trademark of OrbusNeich Medical Company Limited. ©2022 OrbusNeich Medical Company Limited or its affiliates. G-70-2134 Rev01
Indication: The Diamondback 360® Peripheral Orbital Atherectomy Systems are percutaneous orbital atherectomy systems indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and stenotic material from artificial arteriovenous dialysis fistulae.
Important Safety Information: The Systems are contraindicated for use in coronary arteries, bypass grafts, stents, or where thrombus or dissections are present. 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 System and the JADE® PTA Balloon 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.