October 26, 2016
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Smaller-size directional atherectomy system for PAD receives FDA clearance

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Medtronic announced that a smaller size of its directional atherectomy device has been cleared by the FDA to be used in patients with peripheral artery disease.

The system (HawkOne) is now available in a 6F size, according to a press release from the company.

The system can treat patients with multilevel PAD above and below the knee, is capable of treating calcified lesions, and has a preloaded flush tool, which improves cleaning time by up to 55% compared with an older technology, according to the release.

“Considering the complex disease pattern seen in below-the-knee PAD, traditional treatment options such as placement of permanent stents or treatment with a balloon may not be ideal for achieving long-term results. Directional atherectomy, on the other hand, is an established intervention that not only restores patency but also maximizes luminal gain while keeping future treatment options open,” Brian DeRubertis, MD, associate professor of surgery at David Geffen School of Medicine, University of California, Los Angeles, said in the release. “The new, smaller HawkOne 6F device further adds to the versatility of this directional atherectomy system and enables us to treat a larger set of patients with more complex lesions, including patients with challenging calcified lesions.”

Disclosure : DeRubertis reports consulting and speaking for Abbott Vascular, Boston Scientific and Medtronic.