Coronary ViperWire Advance® With Flex Tip Receives FDA Approval

Friday, October 18, 2019

Cardiovascular Systems, Inc. has announced U.S. Food and Drug Administration (FDA) PMA approval 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 is the only atherectomy device to treat 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 Dr. Richard Shlofmitz, Chairman, Department of Cardiology at St. Francis Hospital in Roslyn, NY. “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. Mitchell Krucoff, Professor of Medicine at Duke University Medical Center in Durham, NC, 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.”

Scott Ward, CSI’s Chairman, President and Chief Executive Officer, said, “We remain committed to expanding our portfolio of differentiated products that help physicians deliver improved outcomes for patients with complex coronary artery disease. The U.S. launch of the new ViperWire Advance with Flex Tip is a key addition to our complex coronary offering that includes the Diamondback 360® Coronary Orbital Atherectomy System with GlideAssist®, the Sapphire® balloon portfolio, including the only 1.0 mm coronary angioplasty balloon in the U.S. market, and the Teleport® microcatheter.”

 

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