Cardiovascular Systems (CSI) has announced FDA PMA approval of its ViperWire Advance coronary guidewire with Flex Tip (ViperWire Advance with Flex Tip). A press release reports that the ViperWire Advance with Flex Tip is the latest advancement to CSI’s coronary Diamondback 360 orbital atherectomy system. It adds that the new guidewire offers a combination of flexible nitinol core with a shapeable floppy tip to help physicians navigate in complex anatomy. Additionally, the flexible nitinol body can reduce wire bias during atherectomy.
Richard Shlofmitz (St Francis Hospital, Roslyn, USA) says: “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.”
Scott Ward, CSI’s chairman, president and CEO, says: “We remain committed to expanding our portfolio of differentiated products that help physicians deliver improved outcomes for patients with complex coronary artery disease. The US 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 1mm coronary angioplasty balloon in the US market, and the Teleport microcatheter.”