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
MINNEAPOLIS--(BUSINESS WIRE)-- Manny Villafaña, Chairman and CEO of Kips Bay Medical Inc. (NAS: 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: www.nghs.com
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.
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 release.
Kips Bay Medical, Inc.
Manny Villafaña, 763-235-3540
Chairman and Chief Executive Officer
Manny.Villafana@KipsBayMedical.com
or
Scott Kellen, 763-235-3540
Chief Operating Officer and Chief Financial Officer
Scott.Kellen@KipsBayMedical.com
KEYWORDS: United States North America Georgia Minnesota
INDUSTRY KEYWORDS:
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