Kips Bay Medical Announces the First U.S. Implant in the eMESH I Clinical Feasibility Trial

  Kips Bay Medical Announces the First U.S. Implant in the eMESH I Clinical
  Feasibility Trial

Business Wire

MINNEAPOLIS -- February 5, 2013

Manny Villafaña, Chairman and CEO of Kips Bay Medical Inc. (NASDAQ:KIPS)
announced that on February 5, 2013, the first U.S. patient was implanted with
the eSVS^® Mesh at the Northeast Georgia Heart Center in Gainesville, Georgia.
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. The
procedure was performed by J. Alan Wolfe, MD who stated, “Our first implant of
the eSVS Mesh graft went very smoothly and the patient is doing well and
recovering normally. I am very impressed by the ease of use and excellent
handling characteristics of the eSVS Mesh.” Dr. Wolfe further commented,
“Bypass graft closure is the most significant problem that we find in patients
with atherosclerotic disease. The eSVS Mesh device is designed to prevent
saphenous vein grafts from closing. I believe that it holds the potential to
favorably impact the patient’s quality of life and reduce the need for future,
costly coronary re-interventions.”

Mr. Villafaña added “We are excited to begin clinical study of our eSVS Mesh
here in the United States. This first U.S. implant represents another
significant milestone in the development of our eSVS Mesh technology for
coronary artery bypass surgery.

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 (“SVG”) 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 Northeast Georgia Heart Center, Gainesville, Georgia, USA
Northeast Georgia Heart Center (NGHS) is the state's leader in cardiac care.
The physicians at The Heart Center are consistently recognized as some of the
top cardiovascular physicians in the country. It is through their leadership
and collaboration that Northeast Georgia Medical Center has been recognized as
the #1 heart hospital in the State of Georgia for the last seven years
running, according to HealthGrades © nationally recognized organization to
rank healthcare facilities based on outcomes for a variety of diagnoses and
procedures. Our cardiologists have the experience that leads to expertise. We
perform more than 5,000 cardiac procedures and consult more than 30,000
patients each year. Patients and families can trust the unsurpassed experience
the physicians at The Heart Center provide. Our physicians remain on the
forefront of prevention and disease management by our participation in
clinical research and trials. We contribute at a global level to the
advancement of cardiovascular treatments. For more information on NGHS please
go to:

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

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. Statements in this release regarding the eSVS
Mesh as a tool to improve clinical outcomes 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 U.S. 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


Kips Bay Medical, Inc.
Manny Villafaña, 763-235-3540
Chairman and Chief Executive Officer
Scott Kellen, 763-235-3540
Chief Operating Officer and Chief Financial Officer
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