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.
Safe Harbor
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.