Technology | Guidewires | October 21, 2019

FDA Approves Coronary ViperWire Advance With Flex Tip

U.S. approval of nitinol atherectomy guide wire expands Cardiovascular Systems’ portfolio of products targeting complex coronary disease

FDA Approves Coronary ViperWire Advance With Flex Tip

October 21, 2019 — Cardiovascular Systems Inc. recently announced U.S. Food and Drug Administration (FDA) premarket approval (PMA) of the new ViperWire Advance Coronary Guide Wire with Flex Tip (ViperWire Advance with Flex Tip).

ViperWire Advance with Flex Tip is the latest advancement to CSI’s coronary Diamondback 360 orbital atherectomy system. Diamondback treats calcific coronary artery disease by both safely reducing superficial lesions and creating fractures of deep calcium, facilitating stent delivery, expansion and wall apposition for low restenosis rates.

ViperWire Advance with Flex Tip offers a combination of 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. Together, these benefits can enable physicians to access and effectively treat challenging lesions.

“We are treating increasingly complex coronary disease in older patients with more comorbid conditions,” commented Richard Shlofmitz, M.D., chairman, Department of Cardiology at St. Francis Hospital in Roslyn, N.Y. “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.”

Mitchell Krucoff, M.D., professor of medicine at Duke University Medical Center in Durham, N.C., said, “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.”

For more information: www.csi360.com

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