PAD: Cardiovascular Systems wins FDA nod

Cardiovascular Systems (NSDQ:CSII) said yesterday it won FDA 510(k) clearance for its ViperWire advance peripheral guide wire with flex tip for use with peripheral orbital atherectomy systems, used to treat peripheral artery disease.

The next-generation ViperWire has reduced tip stiffness and comparable torque transfer, as well as improved trackability through the peripheral arteries, the St. Paul, Minn.-based company said.

The new iteration of the device also has a nitinol support coil and a larger proximal core, Cardiovascular Systems said.

“We designed the ViperWire advance with flex tip to improve ease-of-use for our peripheral orbital atherectomy systems when treating complex calcified lesions. By improving the predictability and deliverability of the guide wire, physicians will now have more confidence in their ability to navigate tortuous peripheral anatomy and address PAD in a traditionally difficult-to-treat patient population,” CEO David Martin said in a press release.

Cardiovascular Systems said it plans to release the device in August.

In April,  Cardiovascular Systems won 510(k) clearance from the FDA for a new iteration of its Diamondback 360 peripheral orbital atherectomy device.

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.

 

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