Medical device firm Cardiovascular Systems has received approval from the US Food and Drug Administration (FDA) for its new 4 French (4 Fr) 1.25 Solid Diamondback 360 Peripheral Orbital Atherectomy System (OAS) to treat peripheral artery disease (PAD).
Diamondback Peripheral 145cm systems are available in two crown designs, including the 1.25mm Solid Crown, and 1.25mm Micro Crown, which provide a smaller profile and a more flexible shaft for improved ease of use.
The approval is applicable for both the 145cm systems, comprising new 1.25mm Diamondback 360 Solid Crown that is 4 Fr sheath compatible and modified 1.25mm Diamondback 360 Micro Crown that is 4 Fr sheath compatible.
Cardiovascular Systems president and CEO David Martin said: "Last year we secured FDA clearance for our 60cm peripheral devices which opened up access sites in the foot, allowing physicians to treat challenging lesions in the lower leg.
"This new clearance further expands our 4 Fr, low-profile product portfolio, with longer and enhanced devices. Physicians now have the ability to treat PAD below the knee through as small as 4 Fr access sites in the groin, or to treat the upper leg from foot access sites."
The Stealth 360 and Diamondback 360 Peripheral Orbital Atherectomy Systems are percutaneous orbital atherectomy systems, which are developed for used as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and stenotic material from artificial arteriovenous dialysis fistulae.