Medtronic wins FDA nod for lower-profile HawkOne atherectomy device

Medtronic (NYSE:MDT) said today it won FDA 510(k) clearance for a new lower profile version of its HawkOne directional atherectomy system, designed for treating patients with peripheral artery disease.

The Fridley, Minn.-based company’s HawkOne is a directional atherectomy device designed to treat severely calcified lesions in the blood vessels of the lower extremities. The device removes plaque from the vessel walls to restore healthy blood flow.

“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. 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,” Dr. Brian DeRubertis of UCLA said in prepared remarks.

The win grants clearance to Medtronic for a 6 French size, designed to treat patients with multi-level PAD both above and below the knee. The company touted the tool as easy to use, saying it has a preloaded flush tool to improve cleaning time.

“The expansion of our HawkOne system provides physicians with more options to optimize directional atherectomy as an approach to PAD management, particularly for lesions below the knee. The HawkOne 6F clearance, as well as the recent approval of our 150mm length IN.PACT Admiral drug-coated balloon and clearance of the Trailblazer angled support catheter, reflects our commitment to a full portfolio of products to meet the needs of patients and physicians,” peripheral biz GM & veep Mark Pacyna said in a press release.

The device won 510(k) clearance from the FDA in November 2014, just a few months before Medtronic closed the largest merger in medtech history.

Earlier this month, Medtronic released new economic analysis data from the Fire and Ice trial comparing cryoballoon catheter ablation with radiofrequency ablation, touting advantages of cryoballoon treatment over RF.

Data from the trial was presented at the Asia Pacific Heart Rhythm Society’s Scientific Sessions in Seoul. Primary results from the trial were published in The New England Journal of Medicine, with secondary anaylses published in theEuropean Heart Journal.

The medical giant said that data from the trial indicated that cryoballoon treatment resulted in trial period cost savings due to fewer cardiovascular rehospitalizations and repeat ablations.

The post Medtronic wins FDA nod for lower-profile HawkOne atherectomy device appeared first on MassDevice.

from MassDevice http://ift.tt/2dDHR5Q