eSVS
Animation
Animation
See how to prepare a saphenous vein bypass graft and implant the eSVS Mesh technology.
(MKT-40029.001)
Discover the Benefits of External Saphenous Vein Support
The eSVS Mesh is an extravascular nitinol (nickel titanium alloy) prosthesis placed over the patient’s saphenous vein graft (SVG) during coronary artery bypass surgery (CABG). The eSVS Mesh is intended to maintain long-term SVG graft patency by minimizing undesirable wall stress on the vein so as to avoid the formation of intimal hyperplasia or excessive tissue that can lead to vessel narrowing, reduced blood flow and potential closure of the SVG graft.
Click Here to view Manny's Physician Presentation
Caution: Investigational Device Limited by Federal (or United States) law to investigational use
This device is commercially available for use in select international markets
Media Gallery
View angiogram sets that compare saphenous vien grafts fitted with the eSVS Mesh versus control grafts.
Clinical Case
The eSVS Mesh Deployment, Oliver Reuthebuch, M.D. Universitatsspital Basel
(MKT-40028.001)
"...advancing, refining, and improving cardiac surgery."
Manny Villafaña
- Co-Inventor of the first lithium pacemaker and Founder of CPI/Guidant Corporation
- Co-Inventor of the St. Jude heart valve and Founder of St. Jude Medical Inc.
- Co-Inventor the ATS heart valve and Founder of ATS Medical
- Co-Founder of the Lillehei Surgical Society
- Recipient "Living Legend of Medicine" Award
- USA Master Entrepreneur Award
- Minnesota Business Hall of Fame
- NY Ellis Island Medal of Honor Recipient
- Boys & Girls Club of America Hall of Fame
- Kips Bay Medical is his seventh public company
6 Months Histology
Cross-Section Non-Mesh (Baboon) Vein
Cross-Section Non-Mesh (Baboon) Vein
6 Months Histology Cross-Section
eSVS Mesh (Baboon) Supported Vein
eSVS Mesh (Baboon) Supported Vein
Control (lower) and eSVS Mesh (upper) Vein Implants (Sheep)
The eSVS Mesh was extensively tested in various animals models to demonstrate feasibility of the concept:
- In a series of experimental models two vein bypasses were placed on the heart; one without support and one supported with the eSVS Mesh
- Animals were then followed up with angiography at various time-points
180 Days Sheep Gross Pathology/Histology
Venous graft treated with eSVS MESH
Untreated venous graft - "control"
eSVS® Mesh External Saphenous Vein Support Study
Clinical Study Status July 21st, 2009
Clinical Study Status July 21st, 2009
7 International Sites Enrollment started August 2008 90 Patients All implants successful| CENTER | SITE PI | NUMBER OF PATIENTS ENROLLED |
|---|---|---|
| National University Hospital, Singapore |
Prof. Dr. Uwe Klima A/Prof. Dr. Theo Kofidis |
21 |
| University of Capetown, South Africa |
A/Prof. Dr. Johan Brink | 20 |
| Schleswig-Holstein University Hospital, Kiel, Germany |
Prof. Dr. Med. Jochen Cremer | 25 |
| Hospital Universitario 12 De Octubre, Madrid, Spain |
Prof. Dr. Jose Maria Cortina | 5 |
| Hospital Regional De Sion, Sion, Switzerland |
Dr. Frank Stumpe | 9 |
| Prince Charles Hospital, Brisbane, Australia |
Dr. Trevor Fayers | 2 |
| Auckland City Hospital Auckland, New Zealand |
Dr. Parma Nand | 8 |
6 Months CT Scan (Human)
IVUS Interpretation eSVS Mesh and Control Vein
Segments 14 months Post Implant
(Single Frame at Mid Graft)
Control Vein LCX
eSVS Mesh Vein RCA
CE Mark Approval May, 2010
