According to Kips Bay Medical, the first US implant of its eSVS Mesh was performed at the Northeast Georgia Heart Center in Gainesville, USA, as part of a clinical feasibility trial.
A company press release reported that the feasibility study is being conducted for the FDA at a number of preeminent cardiac surgery centres in both Europe and the USA. The procedure was performed by J Alan Wolfe, 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.”
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 favourably impact the patient’s quality of life and reduce the need for future, costly coronary re-interventions.”
Manny Villafaña, chairman and CEO of Kips Bay Medical, said: “We are excited to begin clinical study of our eSVS Mesh here in the USA. This first US implant represents another significant milestone in the development of our eSVS Mesh technology for coronary artery bypass surgery.”
According to the press release, the eMESH I clinical feasibility trial is a multi-centre, randomised study of external saphenous vein support using Kips Bay Medical’s eSVS Mesh in coronary artery bypass graft 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 support device during CABG surgery. The company expects to enrol up to 120 patients at eight European and four USsites 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 USA.