Valley’s Research Center Participates in International Trial of New Bypass DeviceInnovative Design May Improve Safety; Decrease the Risk of Complications

Jan. 13, 2015

Ridgewood NJ, The Valley Hospital Heart and Vascular Institute is one of 17 preeminent cardiac surgery centers in the United States and Europe selected to participate in a clinical feasibility trial of a new implant designed to support vein grafts used in performing a cardiac bypass procedure. The trial is included among a robust list of clinical trials currently underway through The Valley Hospital Okonite Research Center.Alex Zapolanski, M.D., Director of Cardiac Surgery, and Juan B. Grau, M.D., Director of Cardiac Translational Research and site principal investigator of the trial at Valley, recently performed their first implant of an eSVS® Mesh as part of the Kips Bay Medical eMESH I clinical feasibility trial.

The Company expects to enroll up to 120 patients at 10 European and seven U.S. sites. In addition to The Valley Hospital, the U.S. sites include the Cleveland Clinic, Emory University Hospital Heart and Vascular Center, the Mayo Clinic, the Lenox Hill Hospital, Northeast Georgia Medical Center and the Texas Heart Institute.

“After completing my first case, I found the eSVS Mesh to be remarkably easy to implant and feel very comfortable with the device,” Dr. Zapolanksi said.  “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.”

An estimated 82 million Americans suffer from one or more types of cardiovascular disease. It is the cause of 1 out of every 6 deaths in the U.S., and every year more than 395,000 Americans undergo coronary artery bypass surgery to mitigate its effects.

The Kips Bay Medical eSVS Mesh is designed to address the limitations of saphenous vein grafts used in coronary artery bypass graft (CABG) surgery. The eSVS Mesh is fitted like a sleeve on the outside of saphenous vein grafts to strengthen the grafts. By strengthening the graft and preventing the damaging expansion of the vein graft, Kips Bay hopes to reduce or prevent the resulting injury which can lead to graft failure and potentially costly and complicated re-interventions for patients undergoing CABG surgery. This innovative design is also intended to ensure that blood flow is faster and more laminar, by reducing the diameter mis-match between the graft and target artery.

For more information about open clinical trials, including trials at The Valley Hospital, please visitwww.clinicaltrials.gov.