Cardiovascular Systems (NSDQ:CSII) said today that it won pre-market approval from the FDA for a new ViperWire Advance coronary guidewire for orbital atherectomies using its Diamondback 360 device.
The new guidewire features a floppy, shapeable tip designed to navigate complex anatomies and reduce wire bias, the St. Paul, Minn.-based company said.
“We remain committed to expanding our portfolio of differentiated products that help physicians deliver improved outcomes for patients with complex coronary artery disease,” chairman, president & CEO Scott Ward said in prepared remarks. “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 1.0mm coronary angioplasty balloon in the U.S. market, and the Teleport microcatheter.”
“We are treating increasingly complex coronary disease in older patients with more comorbid conditions,” added Dr. Richard Shlofmitz, of Roslyn, N.Y.’s St. Francis Hospital. “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.”
“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. Mitchell Krucoff, of the Duke University Medical Center in Durham, N.C., said in a press release.