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eSVS® Mesh

The eSVS Mesh is designed to improve the long-term outcome of CABG procedures by addressing limitations of unsupported saphenous veins. The eSVS Mesh is fitted like a sleeve on the outside of a saphenous vein graft to strengthen the vein and to give that vein graft the physiological attributes of an artery by;


  • Strengthening the vein graft to prevent vessel expansion and the resulting damage
  • Reducing vein graft diameter (radial constriction), leading ot a more uniform lumen and faster, arterial-like blood flow through the graft
  • Matching typical compliance (pulsing) of an artery.

 

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 Villafa├▒a


  • 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
 

CONCEPT


The eSVS Mesh is designed to be placed over a saphenous vein graft so as to provide the physiological attributes of an artery by...
 
 
  1. Providing radial constriction (approx. 25%), leading to arterial like flow velocities and shear stresses within the graft
  2. Matching the typical compliance of an artery


 
6 Months Histology
Cross-Section Non-Mesh (Baboon) Vein





 
6 Months Histology Cross-Section
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

30 Days Sheep Angiogram

Untreated Venous Graft - "Control"
Venous Graft Treated with eSVS Mesh





 

90 Days Sheep Angiogram

Untreated Venous Graft - "Control"
Venous Graft Treated with eSVS Mesh



 

180 Days Sheep Gross Pathology/Histology







 Venous graft treated with eSVS MESH
 
 
 
  Untreated venous graft - "control"
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eSVS® Mesh External Saphenous Vein Support Study
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

Angiographic Results
Control vs. eSVS Mesh at 9 Months (Human)

 
Untreated Venous Graft - "Control"
Venous Graft Treated with eSVS Mesh

 

Angiographic Results
Control vs. eSVS Mesh at 9 Months (Human)

Untreated Venous Graft - "Control"
Venous Graft Treated with eSVS Mesh

 

Angiographic Results Venous Graft Treated with eSVS Mesh
Same Patient at 10 and 24 Months

10 months
24 months

 

Angiographic Results Venous Graft Treated with eSVS Mesh
Same Patient at 9 and 36 Months

9 months
36 months

 

Angiographic Results Venous Graft Treated with eSVS Mesh
Same Patient at 9 and 36 Months

9 months
36 months

 
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


US Centers Indicating Interest in Participating
in Kips Bay Medical FDA Clinical Trials



Site Location Surgeons
Cleveland Clinic Cleveland, Ohio Dr. Joseph Sabik
Texas Heart Institute Houston, Texas Dr. Billy Cohn
Emory University Atlanta, Georgia Dr. John Puskas
Mayo Clinic Rochester, Minnesota Dr. Hartzell Schaff
University of California
Medical Center
San Diego, California Dr. Stuart Jamieson
Dr. Michael Madani
Beth-Israel Medical Center New York, New York Dr. Robert Tranbaugh
Lenox Hill Hospital New York, New York Dr. Mani Subramanian
Dr. Nirav Patel
Wisconsin Heart Hospital Milwaukee, Wisconsin Dr. Sam Balkhy