Cardiovascular Systems (St. Paul, Minnesota) won the CE Mark to begin introducing its Stealth 360º Orbital Atherectomy System to the European market. Intended for clearing plaque out of peripheral arteries, the device spins a rod with an attached scraper which, like a sandpaper, removes the build-up from the vessel walls while preventing damage to soft tissue. This procedure hopefully allows for an easier insertion of an angioplasty balloon, while keeping its inflation pressure down to prevent damage to the treated vessel.
The system was approved in the U.S. three years ago.
From the announcement:
Stealth 360º will be available in Europe with a 0.014” guide wire platform, and crown sizes of 1.25mm, 1.50mm, 1.75mm and 2.00mm. The system consists of the following main components: Orbital Atherectomy Device, Saline Pump, Atherectomy guide wire and Atherectomy lubricant—all of which received CE Mark.
“Securing CE Mark for Stealth 360º greatly expands our market opportunity and is an important milestone toward benefiting patients in Europe suffering from PAD—especially those with critical limb ischemia, (CLI) who have been underserved by other treatment options,” said David L. Martin, CSI president and chief executive officer. “A determining factor for CLI is calcium buildup in leg arteries, particularly small vessels below the knee. Our technology, with its unique mechanism of action, has demonstrated it can safely and effectively treat this complex disease, with lasting results.”
Flashback: FDA Approves Cardiovascular CSI’s Stealth 360 System for Treatment of Peripheral Arterial Disease…
Product page: Stealth 360…
Press release: Cardiovascular Systems Receives CE Mark for Stealth 360® Peripheral Orbital Atherectomy System…
