FDA Approves Cardiovascular Systems’ Replacement Saline Infusion Pump
May 04 2017 - 11:50AM
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 HarborCertain 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20170504006248/en/
Cardiovascular Systems, Inc.Jack Nielsen,
651-202-4919j.nielsen@csi360.comorPadillaMatt Sullivan,
612-455-1709matt.sullivan@padillaco.com
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