CSI's Coronary ViperWire Advance With Flex Tip Gains FDA Approval

September 24, 2019—Cardiovascular Systems, Inc. (CSI) announced FDA premarket approval of the company's ViperWire Advance coronary guide wire with Flex Tip, which is the latest advancement in CSI’s coronary Diamondback 360 orbital atherectomy system (OAS).

According to CSI, ViperWire Advance with Flex Tip is designed to access and effectively treat challenging lesions. The device features a flexible nitinol core with a shapeable floppy tip to help physicians navigate in complex anatomy. In addition, the flexible nitinol body can reduce wire bias during atherectomy.

The Diamondback OAS treats calcific coronary artery disease by both safely reducing superficial lesions and creating fractures in deep calcium, facilitating stent delivery, expansion, and wall apposition with low restenosis rates.

In CSI's announcement, Richard Shlofmitz, MD, commented, “We are treating increasingly complex coronary disease in older patients with more comorbid conditions. Many of these patients have calcified coronary lesions which can lead to poor outcomes. Enhancing trackability and performance of atherectomy with ViperWire Advance with Flex Tip will help me more effectively treat calcific disease.” Dr. Shlofmitz is Chairman, Department of Cardiology at St. Francis Hospital in Roslyn, New York.

Mitchell Krucoff, MD, added, “With a shapeable floppy tip and flexible nitinol body, ViperWire Advance with Flex Tip will help physicians efficiently gain lesion access in complex anatomy and reduce wire bias during treatment. This can be a game changer for patient care.” Dr. Krucoff is Professor of Medicine at Duke University Medical Center in Durham, North Carolina.