ST. PAUL, Minn.--(BUSINESS WIRE)--Cardiovascular Systems, Inc. (CSI) (Nasdaq: CSII) today announced that the U.S. Food and Drug Administration (FDA) has approved its premarket approval application (PMA) 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.
About Cardiovascular Systems, Inc.
Cardiovascular Systems, Inc., based in St. Paul, Minn., is a medical device company focused on developing and commercializing innovative solutions for treating vascular and coronary disease. The company’s Orbital Atherectomy Systems treat calcified and fibrotic plaque in arterial vessels throughout the leg and heart in a few minutes of treatment time, and address many of the limitations associated with existing surgical, catheter and pharmacological treatment alternatives. The U.S. FDA granted the first 510(k) clearance for the use of the Orbital Atherectomy System in peripheral arteries in August 2007. In October 2013, the company received FDA approval for the Coronary Orbital Atherectomy System. To date, over 308,000 of CSI’s devices have been sold to leading institutions across the United States.
Certain statements in this news release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and are provided under the protection of the safe harbor for forward-looking statements provided by that Act. For example, statements in this press release regarding the recall of one type of its Saline Infusion Pump, including the timing of the replacement of all recalled units, are forward-looking statements. These statements involve risks and uncertainties that could cause results to differ materially from those projected, including, but not limited to, future actions by the FDA and other regulatory bodies; CSI’s failure to adequately assess the cause and effect of the issues with the Pump that led to the recall; the ability of CSI to adequately modify the Pump design in order to prevent this issue from happening in the future; the ability of CSI to obtain sufficient components from suppliers to manufacture replacement Pumps; the ability of CSI to replace the affected Pumps in a timely and effective manner; the potential that CSI may subsequently discover additional Pumps subject to recall; customer reactions to the recall; the effect on CSI’s reputation of the recall; the possibility that this recall could subject CSI to claims or proceedings that may adversely impact its business and financial condition; and other factors detailed from time to time in CSI’s SEC reports, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. CSI encourages you to consider all of these risks, uncertainties and other factors carefully in evaluating the forward-looking statements contained in this release. As a result of these matters, changes in facts, assumptions not being realized or other circumstances, CSI's actual results may differ materially from the expected results discussed in the forward-looking statements contained in this release. The forward-looking statements made in this release are made only as of the date of this release, and CSI undertakes no obligation to update them to reflect subsequent events or circumstances.