Minnesota’s Cardiovascular Systems (NSDQ:CSII) won 510(k) clearance from the FDA for a new, smaller iteration of its Diamondback 360 peripheral orbital atherectomy device
The federal safety watchdog cleared the 4-French 1.25 Solid Diamondback 360 device to treat peripheral artery disease, including 2 smaller access sheaths for the minimally invasive therapy, Cardiovascular systems 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," president & CEO David Martin said in prepared remarks. "This new clearance further expands our 4Fr low-profile product portfolio, with longer and enhanced devices. Physicians now have the ability to treat PAD below the knee through as small as 4Fr access sites in the groin, or to treat the upper leg from foot access sites."
Last December, Cardiovascular Systems closed enrollment in the Japanese arm of a trial of its coronary atherectomy device, which it hopes to use to back approval bids in both countries.
The company won CE Mark approval in the European Union in November for its Stealth 360 atherectomy system to treat severe peripheral artery disease.
Cardiovascular Systems announced last August that it was recalling some of its Diamondback 360 devices due to the risk that a component could fracture during the procedure and cause an embolism.
