VirtuoSaph® Endoscopic Vein Harvesting System Provides Conduits of Similar Quality to Those Obtained Via the Open “No-Touch” Method
Ann Arbor, Michigan — July 28, 2011 — A recent clinical study entitled "Evaluation of Endoscopic Vein Extraction on Structural and Functional Viability of Saphenous Vein Endothelium” was published in the Journal of Cardiothoracic Surgery on June 10, 2011. JCS is an open access, peer-reviewed online journal that encompasses all aspects of research in the field of cardiothoracic surgery. Dr. Hemant S. Thatte; Associate Professor of Cardiothoracic Surgery Harvard Medical School and Brigham and Women's Hospital; and Director, Cardiac Surgery Research at the VA Boston Healthcare System was the principal scientific investigator of this study.
About the Study
This study aimed to isolate vein harvesting performance from the entire coronary artery bypass grafting procedure and any other confounding factors. Previous studies have shown that endoscopic vein harvesting (EVH) causes structural and functional damage to the saphenous vein endothelium. The cause of the damage, however, may depend on the extraction technique. In order to further assess this situation, this study evaluated the effect of the VirtuoSaph Endoscopic Vein Harvesting System on the structural and functional viability of saphenous vein endothelium using multiphoton imaging, biochemical and immunofluorescence assays.
Study highlights included:
- Nineteen patients scheduled for coronary artery bypass graft (CABG) surgery were prospectively identified. Each underwent VirtuoSaph System endoscopic vein harvesting (VsEVH) for one portion of the harvesting procedure and "no-touch” open saphenous vein harvesting (OSVH) for the other portion.
- The harvesting of the saphenous vein using the VirtuoSaph System did not reveal any structural and functional cellular damage. Morphological structure, esterase activity and endothelial viability were well maintained in the VsEVH samples, and were similar to those observed in the corresponding samples harvested by the OSVH technique.
Dr. Thatte wrote that "Morphological, biochemical and immunofluorescence parameters of viability, structure and function were well preserved in VsEVH group as in OSVH group”. He goes on to say that the results of this study clearly demonstrate that endoscopic harvesting of the saphenous vein using the VirtuoSaph System does not cause structural damage to the endothelium and the smooth muscle. Further comparative study is required to examine graft patency rates at one year post operatively. Additionally, Dr. Thatte and his team are currently studying the possible negative effects of CO2 on vein structure and function.
In a post study interview, Dr. Thatte stated that "Based on this comparative study I feel assured that it's not the endoscopic vessel harvesting that is responsible for graft failure. My study gives some hope to me, and perhaps to the surgeon, that the device and the training are important. I truly believe that endoscopic vessel harvesting is an advancement that cannot be reworked; it's here to stay.”
About Terumo Cardiovascular Systems
Terumo Cardiovascular Systems Corporation manufactures and markets medical devices for the global cardiac surgery market. The company is headquartered in Ann Arbor, Michigan with manufacturing operations in Ann Arbor; Elkton, Maryland; and Ashland, Massachusetts. It is one of several subsidiaries of Terumo Corporation of Japan that is focused exclusively on cardiac and vascular specialties. Terumo CVS entered into consent decree with FDA regarding improvements to the Quality System at its Ann Arbor manufacturing facility. For more information, visit www.terumo-cvs.com.
About Terumo Corporation
Terumo Corporation is a premier global medical device company with annual sales of more than 3.4 billion dollars for the fiscal year ending March 31, 2010. Founded in 1921, the company develops, manufactures and distributes world-class medical devices, such as syringes, blood bags and IV solutions. Terumo has the biggest share of the world markets for angiography guide wires and perfusion products and is a leading developer of interventional products, such as catheters and stents. For more information, visit www.terumo.com.
Global Sr. Product Manager
Terumo Cardiovascular Systems Corp.