Medtronic receives CE Mark for directional atherectomy system for PAD patients

Medtronic announced on Jan. 24 that it had received a CE Mark in Europe for its HawkOne 6F directional atherectomy system for patients with peripheral artery disease (PAD).

In October, the FDA approved the system in a 6 French size. The FDA originally approved the system in November 2014.

More than 200 million people worldwide and 12 million people in the U.S. have PAD, according to Medtronic. Patients with PAD have arteries in the legs that are narrowed or blocked by plaque.

“Directional atherectomy is an established treatment modality for patients with complex PAD to restore patency, maximize luminal gain and preserve future treatment options,” Thomas Zeller, MD, head of the department of angiology at Universitäts-Herzzentrum Freiburg in Bad Krozingen, Germany, said in a news release. “The new smaller HawkOne 6F size is an advanced option to treat patients with multi-level PAD, addressing lesions of various length, morphology, and location, particularly those below the knee.”

Medtronic gained access to the HawkOne when it acquired Covidien for approximately $50 billion in January 2015. The company’s directional atherectomy portfolio also includes the TurboHawk and SilverHawk systems.

The company said that directional atherectomy could also be used an adjunctive treatment before using Medtronic’s IN.PACT Admiral drug-coated balloon.