MINNEAPOLIS, Nov. 11, 2014 (GLOBE NEWSWIRE) -- Manny Villafaña, Chairman and CEO of Kips Bay Medical, Inc. (OTCQB:KIPS), announced that on November 4, 2014, cardiac surgeons at The Valley Hospital’s Heart and Vascular Institute in Ridgewood, New Jersey, performed their 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 Alex Zapolanski, M.D., Director of Cardiac Surgery at The Valley Hospital and Clinical Professor of Surgery, Columbia University College of Physicians and Surgeons; and Juan B. Grau, M.D., Director of Cardiac Translational Research at The Valley Hospital and Associate Professor of Surgery, Columbia University College of Physicians and Surgeons and site principal investigator; at the Valley Hospital Heart and Vascular Institute. Dr. Zapolanski commented, “After completing my first case, I found the eSVS Mesh to be remarkably easy to implant and feel very comfortable with the device. I am pleased that we are able to be part of the eMESH I trial and it is my hope that this device will open the door to improved long-term outcomes for CABG surgery patients.”
The eMESH I clinical feasibility trial is a multi-center, randomized study of external saphenous vein graft (SVG) support using Kips Bay Medical’s eSVS Mesh in coronary artery bypass grafting (CABG) surgery. The objective of the trial is to demonstrate to the FDA the initial safety and performance of the eSVS Mesh for use as an external SVG support device during CABG surgery. If the trial is successful, the Company intends to use the data from this study as the basis for the filing of a request for an investigational device exemption, or IDE, to perform a larger pivotal study.
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. 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 ten European and seven U.S. sites and, if the trial is successful, intends 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 and quarterly report on Form 10-Q filed with the U.S. Securities and Exchange Commission.
About the Valley Hospital
The Valley Hospital is a fully accredited, acute care, not-for-profit hospital serving more than 440,000 people in 32 towns in Bergen County and adjoining communities. The Valley Hospital is part of Valley Health System that also includes Valley Home Care and Valley Medical Group. The Valley Hospital is affiliated with the New York-Presbyterian Healthcare System. Known throughout northern New Jersey for its medical and technical excellence, Valley is a leader in the field of cardiology services. The service includes a full range of diagnostic and interventional cardiac treatment services, including cardiac surgery, coronary angioplasty and electrophysiology studies. At the forefront of the development of new techniques in open heart surgery, Valley offers Off-Pump Coronary Artery Bypass (OPCAB), one of the newest procedures available today.
For more information about The Valley Hospital, visit www.valleyhealth.com.
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.
Forward-Looking Statements Safe Harbor
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 “believes,” “expects,” “continues,” “intends,” “should,” “will,” “may,” “can be,” “believes,” “could,” “hopes,” “anticipates,” “objective,” “future,” other words of similar meaning or the use of future dates. Examples of forward-looking statements in this release include Kips Bay’s plans and expectations regarding enrollments, patients required to complete its trial 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, in particular, the status of the eMESH I clinical feasibility trial, including enrollment, completion and the results; and its need for, and ability to obtain, additional financing; and the terms of any such additional financing, which could be highly dilutive and adversely affect the rights of its current stockholders. If Kips Bay is unable to obtain additional financing when needed or if its eMESH I clinical feasibility trial is not successful, the Company may not be able to continue as a going concern and may be forced to cease operations. Other uncertainties and risks that may cause Kips Bay’s actual results to be materially different than those expressed in or implied by Kips Bay’s forward-looking statements include, among others, Kips Bay’s future operating results and financial performance; surgeon acceptance of the 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 the eSVS Mesh technology and the extent of such coverage; the development of its distribution and marketing capabilities; and its ability to retain and attract 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.
Contact:
Kips Bay Medical, Inc.
Manny Villafaña, Chairman and Chief Executive Officer, +1-763-235-3540
Email: Manny.Villafana@KipsBayMedical.com
or
Scott Kellen, Chief Operating Officer and Chief Financial Officer, +1-763-235-3540
Email: Scott.Kellen@KipsBayMedical.com
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