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May 4, 2017
FDA Approves CSI's Replacement Saline Infusion Pump
May 5, 2017—Cardiovascular Systems, Inc. (CSI) announced that the US Food and Drug Administration (FDA) has approved the company's premarket approval application supplement for a redesigned saline pump used as part of the company’s Diamondback 360 orbital atherectomy systems (OAS).
The 70057-03 Saline Infusion Pump will replace CSI’s 7-10014 Saline Infusion Pump, which the company voluntarily recalled on April 17, 2017. The company anticipates replacing all recalled units by no later than August 31, 2017.
CSI's OAS devices treat calcified and fibrotic plaque in arterial vessels throughout the heart and legs. In 2013, CSI received premarket approval from the FDA to market its coronary OAS device as a treatment for severely calcified coronary arteries. The FDA granted 510(k) clearance for the use of the OAS in peripheral arteries in August 2007.
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