Kips Bay Medical Announces the First eSVS® Mesh Implant by the Mayo Clinic
MINNEAPOLIS -- May 02, 2013
Manny Villafaña, Chairman and CEO of Kips Bay Medical, Inc. (NASDAQ:KIPS)
announced that on April 30, 2013, the Mayo Clinic performed its first implant
of an eSVS^® Mesh at its Rochester, Minnesota facility. This implant was
performed as part of the Kips Bay Medical eMESH I clinical feasibility trial
currently being conducted for the U.S. FDA in a number of preeminent cardiac
surgery centers in both Europe and the United States.
Mr. Villafaña stated “We are honored to have such a prestigious center as the
Mayo Clinic participating in our eMESH I trial.”
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 coronary
artery bypass graft (“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 support device during 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 the filing of
a request for an investigational device exemption to perform a pivotal trial
in the United States.
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 on the outside of 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. Statements in this release regarding the eSVS
Mesh as the Company expecting to enroll up to 120 patients at eight European
and four U.S. sites and the use of the data from this study as the basis for
filing a request for an investigational device exemption to perform a pivotal
trial in the United States are examples of forward-looking statements. These
forward-looking 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 release.
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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