Company Distributes Product and Is Coordinating Recall with
Manufacturer
No Material Effect on CSI Financial Results Is Expected
ST. PAUL, Minn.--(BUSINESS WIRE)--Nov. 16, 2009--
Cardiovascular Systems, Inc. (CSI) (Nasdaq: CSII) has announced a
voluntary recall of all lots of the ViperSheathTM Sheath
Introducer on behalf of Thomas Medical due to reports about stretching
or fracture of the sheath during use. CSI initiated the nationwide
recall on November 2, 2009.
The ViperSheathTM Sheath Introducer is a product developed
and manufactured by Thomas Medical Products, Inc., and distributed by
CSI. It is a long-coil reinforced, kink-resistant catheter sheath that
facilitates percutaneous, or through the skin, entry of an intravascular
device.
Thomas Medical initiated this recall due to the possibility of fractures
in the device. In the event of a device fracture, separated segments of
the device may require unplanned open surgery to remove the retained
segments or control bleeding. Since this device is coil reinforced, any
separation of the cannula (a flexible tube inserted into the body) has
the potential to expose portions of the coil, creating the potential for
vessel dissection or perforation.
If a procedure has been completed successfully using this product, no
further action needs to be taken. To date, CSI is aware of three
instances where a ViperSheathTM Sheath Introducer encountered
the issues related to this recall. No permanent patient injuries have
been reported. In these instances, successful surgical interventions
were performed to retrieve a portion of the sheath. CSI has notified all
customers by FedEx about the recall and is arranging for the return of
all products. Customers with questions may contact CSI at 1-877-274-0360.
The recall encompasses products distributed from March 25, 2009 to
October 21, 2009, and includes the following lot ranges and catalog
numbers:
-
Lot range: S28117 through S29174
-
Catalog numbers: VPR-ISH 5 X 85, VPR-ISH 6 X 85, VPR-ISH 7 X 85,
VPR-ISH 5 X 45, VPR-ISH 6 X 45, VPR-ISH 7 X 45
CSI is working with Thomas Medical, which has apprised the U.S. Food and
Drug Administration (FDA) of this action. Any adverse events with the
use of this product and/or quality problems should be reported via the
FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch,
HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the
MedWatch Web site at www.fda.gov/medwatch.
CSI does not expect the voluntary recall to have a material effect on
its financial results. The product accounts for less than one percent of
CSI’s current revenue.
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 the ViperSheath product,
CSI's expectation that the ViperSheath recall will not have a material
effect on its financial results, and procedures completed using the
ViperSheath product, 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, negative
reaction to the recall, a decline in the use of the other products CSI
manufactures, sells or distributes, litigation or FDA action relating to
the recall, CSI's actual financial results, general economic conditions
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.
About Cardiovascular Systems, Inc.
Cardiovascular Systems, Inc., based in St. Paul, Minn., is a medical
device company focused on developing and commercializing interventional
treatment systems for vascular disease. The company’s Diamondback 360®
PAD System treats calcified and fibrotic plaque in arterial vessels
throughout the leg, and addresses many of the limitations associated
with existing surgical, catheter and pharmacological treatment
alternatives. In August 2007, the U.S. FDA granted 510(k) clearance for
the use of the Diamondback 360° as a therapy for PAD (peripheral
arterial disease), and CSI commenced a U.S. product launch in September
2007. Since then, more than 600 hospitals across the United States have
adopted the system.
For more information visit the company’s Web site at www.csi360.com.
Source: Cardiovascular Systems, Inc.
For Cardiovascular Systems, Inc.
Product
Recall
Roger Hamilton, 651-259-1645
rhamilton@csi360.com
or
Investor
Relations
651-259-2800
investorrelations@csi360.com
or
Padilla
Speer Beardsley:
Marian Briggs, 612-455-1742
mbriggs@psbpr.com
or
Nancy
A. Johnson, 612-455-1745
njohnson@psbpr.com