Kips Bay Medical Announces FDA Approval of Additional US Study Patients
MINNEAPOLIS -- January 23, 2013
Kips Bay Medical, Inc. (NASDAQ:KIPS) along with Manny Villafaña, its Founder,
Chairman and CEO, announced today that the United States Food & Drug
Administration (“FDA”) has granted approval for additional US patients to be
enrolled in Kips Bay Medical’s “eMESH I” clinical feasibility trial of its
In its initial approval, the FDA indicated that it would allow a staged
enrollment within the United States, starting with five patients at up to four
sites in the United States. The FDA has now increased the approved number of
patients from five to fifteen(15).
As previously reported, Kips Bay Medical will provide six month follow-up
angiograms on the first ten patients, from the U.S. and Europe combined, for
the FDA to review. If the FDA determines that these angiograms are acceptable,
Kips Bay Medical expects to receive the approval from the FDA to enroll the
remaining U.S. patients.
The eMESH I clinical feasibility trial is a multi-center, randomized study of
external saphenous vein support using Kips Bay Medical’s eSVS Mesh in CABG
Surgery. The objective of this study is to demonstrate the initial safety and
performance of the eSVS Mesh for use as an external saphenous vein graft
(“SVG”) support device during coronary artery bypass (“CABG”) surgery. The
Company expects to enroll up to 120 patients at eight European and four U.S.
sites and further expects to use the data from this study as the basis for a
pivotal trial in the U.S.
About Kips Bay Medical
Kips Bay Medical, Inc., founded in 2007 and headquartered in Minneapolis,
Minnesota, is a medical device company focused on manufacturing and
commercializing its external saphenous vein support technology, or eSVS Mesh,
for use in coronary artery bypass grafting surgery. The eSVS Mesh is a nitinol
mesh sleeve that, when placed over a saphenous vein graft during CABG surgery,
is designed to improve the structural characteristics and long-term
performance of the saphenous vein graft. Additional information about Kips Bay
Medical, Inc. can be found at www.KipsBayMedical.com.
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 Kips Bay Medical expectations of further approvals and patient
enrollments are forward-looking statements. These statements involve risks and
uncertainties which could cause results to differ materially from those
projected, including but not limited to the risks detailed from time to time
in Kips Bay Medical’s SEC reports, including its most recent annual report on
Form 10-K and subsequent quarterly reports on Form 10-Q. Kips Bay Medical
encourages you to consider all of these risks, uncertainties and other factors
carefully in evaluating the forward-looking statements contained in this
Kips Bay Medical, Inc.
Manny Villafaña, +1-763-235-3540
Chairman and Chief Executive Officer
Scott Kellen, +1-763-235-3540
Chief Operating Officer and Chief Financial Officer
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