MINNEAPOLIS, March 17, 2014 (GLOBE NEWSWIRE) -- Kips Bay Medical, Inc. (Nasdaq:KIPS) along with Manny Villafaña, its Founder, Chairman and CEO, announced today that the United States Food & Drug Administration ("FDA") has granted an approval for Kips Bay Medical to include more U.S. patients and U.S. study sites in its "eMESH I" clinical feasibility trial of its eSVS® Mesh.
In its initial approval, the FDA indicated that it would allow a staged enrollment within the United States, starting with 15 patients at up to four sites in the United States. The FDA has now increased the approved number of U.S. patients from 15 to 27 (15 additional from the 12 enrolled to date) and increased the allowed number of U.S. sites from four to 10.
In addition, the FDA has also approved a combination of changes in the application of the eSVS Mesh to the saphenous vein graft and to the surgical implant technique for the eSVS Mesh treated graft. The changes are intended to reduce the risk of early graft occlusion, make it easier to implant the eSVS Mesh and reduce procedural costs.
"We are very pleased with this expanded approval which allows the Cleveland Clinic, the Lenox Hill Hospital and other interested U.S. sites to become active and commence enrolling patients in our eMESH I clinical feasibility trial," commented Manny Villafaña, Founder, Chairman and CEO of Kips Bay. "I am grateful for the perseverance of our team here at Kips Bay and their dedication to bringing the eSVS Mesh forward through the U.S. regulatory process."
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 ("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 intends to work with its European and U.S. sites to use its newly approved implant technique on all patients going forward and further expects to use the data from this study as the basis for requesting an investigational device exemption to conduct a larger 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.
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," "continues", "expects," "intends," "should," "will," "may," "could," "hopes," "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 expectations regarding enrollments, site activations and other aspects of its eMESH I clinical feasibility trial; the safety, performance and benefits of the eSVS Mesh and the anticipated effects of the changes in the application 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 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; its ability to attract and retain scientific, regulatory, and sales and marketing support personnel and its ability to obtain additional financing. 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. Kips Bay undertakes no obligation to update its forward-looking statements.