Kips Bay Medical Announces the First eSVS ® Mesh Implant by the Emory University Cardiothoracic Clinical Research Unit
MINNEAPOLIS--(BUSINESS WIRE)-- Manny Villafaña, Chairman and CEO of Kips Bay Medical Inc. (NAS: KIPS) , announced that on September 4, 2013, the Emory Heart & Vascular Center in Atlanta, Georgia, performed its first implant of an eSVS® Mesh. This implant was performed as part of the Kips Bay Medical eMESH I clinical feasibility trial currently being conducted for the U.S. Food and Drug Administration (FDA) in a number of preeminent cardiac surgery centers in both Europe and the United States.
The procedure was performed by Professor John D. Puskas, M.D., who is a Principal Investigator for the eMESH I clinical feasibility trial, and founder of the Cardiothoracic Clinical Research Unit within the Emory Heart & Vascular Center, who stated, "We are excited to be enrolling patients in the eMESH I clinical feasibility study. There is a great need to improve long term patency of saphenous vein grafts used in coronary artery bypass surgery and the eSVS Mesh may be a tool to help accomplish that."
Mr. Villafaña added "We are pleased to have the opportunity to work with Dr. Puskas and the Emory Heart & Vascular Center, one of the truly outstanding clinical research facilities here in the United States."
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 (IDE) to perform a pivotal trial in the United States.
About the eSVS Mesh
The eSVS Mesh is designed to be fitted like a sleeve on the outside of saphenous vein grafts to strengthen SVGs used in coronary artery bypass graft surgery. By strengthening the SVG and preventing the damaging expansion of the vein graft, the Company hopes to reduce or prevent the resulting injury which can lead to SVG failure and potentially costly and complicated re-interventions for patients undergoing CABG surgery. To strengthen an SVG, the eSVS Mesh is manufactured from nitinol wire which gives the eSVS Mesh considerable strength, while remaining highly flexible and kink-resistant. Kips Bay is currently conducting a feasibility trial for the FDA, the objective of which is to demonstrate the initial safety and performance of the eSVS Mesh. Kips Bay 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 IDE to perform a larger pivotal study which is required to demonstrate clinical effectiveness and support a request for approval to sell the eSVS Mesh in the United States. Additional information about the eSVS Mesh and the Company's feasibility trial are available at the Company's website at www.KipsBayMedical.com and in the Company's most recent annual report on Form 10-K filed with the U.S. Securities and Exchange Commission.
About the Emory University Hospital Heart & Vascular Center, Atlanta, Georgia, USA
The Emory Heart & Vascular Center in Atlanta, GA is comprised of four major areas of cardiovascular care-- cardiology, vascular surgery, cardiothoracic surgery and cardiac imaging. Emory's Heart & Vascular Center is consistently recognized by U.S. News & World Report as one of the top heart health centers in the nation. Each area is committed to providing superior cardiac and vascular patient care, promoting overall heart health, pioneering innovative clinical cardiovascular research, and training the best heart specialists and cardiologists in the world. For more information about the Emory Heart & Vascular Center, visit www.emoryhealthcare.org.
About Kips Bay Medical
Kips Bay Medical, Inc. is a medical device company focused on manufacturing and commercializing its external saphenous vein support technology, the eSVS Mesh, for use in coronary artery bypass grafting surgery. Kips Bay originally acquired the eSVS Mesh technology from Medtronic, Inc. in 2007. Additional information about Kips Bay is available at the Company's website at www.KipsBayMedical.com.
Statements contained in this release that relate to future events are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Forward-looking statements are based on current expectations of future events and often can be identified by words such as "may," "expects," "may," "believes," "could," "hopes," "objective," "potential," "future," other words of similar meaning or the use of future dates. Examples of forward-looking statements in this release include Kips Bay's expectations regarding enrollments, site activations and other aspects of its eMESH I clinical feasibility trial; and the safety, performance and benefits of the eSVS Mesh. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause Kips Bay's actual results to be materially different than those expressed in or implied by Kips Bay's forward-looking statements. For Kips Bay, such uncertainties and risks include, among others, the status of the eMESH I clinical feasibility trial, including enrollment, completion and the results; Kips Bay's future operating results and financial performance; market size and market acceptance of its eSVS Mesh technology; the ability of Kips Bay and its distributors to commercialize and sell the eSVS Mesh in Europe; its ability to obtain coverage and reimbursement from third-party payors for its eSVS Mesh technology and the extent of such coverage; the development of its distribution and marketing capabilities; and its ability to attract and retain scientific, regulatory, and sales and marketing support personnel. More detailed information on these and other factors that could affect Kips Bay's actual results are described in Kips Bay's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. Kips Bay undertakes no obligation to update its forward-looking statements.
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
KEYWORDS: United States North America Georgia Minnesota
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