The eSVS Mesh is a highly flexible, semi-compliant, kink-resistant extravascular tubular prosthesis made of knitted nickel/titanium (nitinol) wire. The eSVS Mesh is designed for maintaining the patency of autologous vein grafts (i.e. saphenous vein) used in coronary artery bypass grafting (CABG) surgery.
Within the product box comes a packaged sterile eSVS Mesh (A) mounted on a flared, color-coded DELIVERY TUBE (B) that is threaded over a SUTURE SNARE wire (C) Two SIZING TOOLS (D) are included in separate sterile packages within the product box. See Figure 1 below.
The eSVS Mesh is indicated for maintaining saphenous vein bypass graft patency in patients undergoing coronary artery bypass graft procedures, utilizing autologous saphenous vein grafts with external diameters from 3.6 mm to 7.0 mm and double wall thicknesses less than 1.4 mm.
- Do not use this product in patients with a known infection or suspected infection in the field of operation.
- Do not use this product in patients with a known allergy to nitinol or its components (nickel and titanium).
- Do not use this product in patients with an implantable defibrillator (presently, there is insufficient data on patients with both an implanted defibrillator and an eSVS Mesh).
- Prior to use, if the sterility or integrity of the packaging is suspect or compromised, do not use the product. DO NOT RESTERILIZE.
- The eSVS Mesh is designed for single use only. DO NOT REUSE OR RESTERILIZE any unused device or unused portion of a device that has been opened to the sterile field.
- Do not use clips to ligate the side branches of the vein graft.
- The eSVS Mesh should be deployed over the entire length of the vein graft.
- Do not use more than one eSVS Mesh per vein graft.
- The eSVS Mesh should be maintained on its DELIVERY TUBE until deployment onto a vein graft. Manual attempts to remount the device on the DELIVERY TUBE can result in damage to the device.
- Do not attempt to cut the eSVS Mesh with a scalpel blade. This can result in damage to the device and the vein graft.
- Preparation of the eSVS Mesh graft for the aortic anastomotic site should be performed as described in this Instructions for Use. Failure to perform the aortic anastomotic site in the described manner can result in graft failure.
- The transmission of electrical energy during defibrillation has not been studied with the eSVS Mesh at this time. Therefore, during internal electrical defibrillation of the heart, direct contact with the eSVS Mesh should be avoided.
- The eSVS Mesh should only be used by physicians who have been trained by Kips Bay Medical, Inc. or its representatives.
- Allergic reaction to nitinol or its components (nickel and titanium).
- Possibility of damage to the vein graft that the eSVS Mesh is placed over, thereby requiring repair.
The eSVS Mesh is MR-Conditional according to the terminology specified in the American Society for Testing and Materials (ASTM) International, Designation: F2503-05. Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment. ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, Pennsylvania, 2005.
Non-clinical testing demonstrated that the eSVS Mesh is MR-Conditional. A patient with this device can be scanned safely immediately after placement under the following conditions:
- Static magnetic field of 3-Tesla or less.
- Maximum spatial gradient magnetic field of 720-Gauss/cm or less.
In non-clinical testing, the eSVS Mesh produced the following temperature rises during MRI performed for 15 min. in 1.5-Tesla (1.5-Tesla/64-MHz, Magnetom, Siemens Medical Solutions, Malvern, PA. Software Numaris/4, Version Syngo MR 2002B DHHS) and 3-Tesla (3-Tesla/128-MHz, Excite, Software G3.0-052B, General Electric Healthcare, Milwaukee, WI) MR systems, as follows:
| Highest temperature change | MRI Condition |
| +1.8°C | 1.5-T/64-MHz |
| +2.2°C | 3-T/128-MHz |
Therefore, the MRI-related heating experiments for the eSVS Mesh at 1.5-Tesla and 3-Tesla using transmit/receive RF body coils at MR system reported whole body averaged SARs of 3.8-W/kg (i.e., associated with a calorimetry value of 3.1-W/kg at 1.5-Tesla) and 3.0-W/kg (i.e., associated with a calorimetry value of 2.8-W/kg at 3-Tesla), respectively, indicated that the greatest amount of heating that occurred in association with these specific conditions was equal to or less than 1.8°C at 1.5-Tesla and 2.2°C at 3-Tesla.
MR image quality may be compromised if the area of interest is in the same area or relatively close to the position of the eSVS Mesh. The artifact size information is, as follows:
| Signal Void Size | 1,128-mm2 | 28-mm2 | 1,818-mm2 | 37-mm2 |
|---|---|---|---|---|
| Imaging Plane | parallel | perpendicular | parallel | perpendicular |
Therefore, optimization of MR imaging parameters to compensate for the presence of this device may be necessary.
- 1 pouch containing an eSVS Mesh (25 cm length, and either 3.5, 4.0, or 4.5 mm in diameter) mounted on a color-coded, flared DELIVERY TUBE
- 1 SUTURE SNARE for use in loading the eSVS Mesh onto a vein
- 2 small pouches each containing a SIZING TOOL for use in determining acceptable wall thickness and selection of eSVS Mesh diameter
STERILIZATION
The eSVS Mesh is sterilized by ethylene oxide. The contents of the package are sterile as long as the pouch is undamaged, unopened and the directions concerning storage and expiration date are followed.
STORAGE
No special storage conditions required.
EXPIRATION
The Use By date is indicated on the front of each package box and on the inner pouches. Do not utilize a device beyond the Use By date.
OPENING THE PACKAGE
Before use, the product box must be opened and the contents removed. The inner pouch containing one SIZING TOOL should be peeled open first and the contents presented to the user under aseptic conditions.
1. Harvest the vein graft per standard clinical practice (e.g. open incision, bridged incision, endoscopic). Remove excess connective tissue from the outer surface.
2. Cannulate the proximal end of the vein graft (the proximal end is defined as the end that will be anastomosed to the aorta). Cut the vein graft to the desired graft length plus at least 2 cm excess.
3. Remove any clips from the side branches of the vein graft. Trim off excess side branch length.
4. Ligate or oversew the side branches using 7-0 polypropylene suture.
5. Inflate the vein graft with heparinized blood or physiologic crystalloid solution using sufficient pressure to check for leaks and overcome spasm.
6. Repair any leaks in the vein graft with 7-0 polypropylene suture.
The SIZING TOOL included in each product box is used to determine if the saphenous vein wall thickness is acceptable and defines the saphenous vein graft diameter range to be used with each device size. The table below indicates the saphenous vein graft size used with each device size:
| eSVS Mesh Inside Diameter |
Saphenous Vein Graft Outside Diameter | |||
|---|---|---|---|---|
| Minimum | % Diameter Reduction |
Maximum | % Diameter Reduction |
|
| 3.5 mm | 3.6 mm | 3 | 4.1 mm | 15 |
| 4.0 mm | 4.2 mm | 5 | 5.4 mm | 26 |
| 4.5 mm | 5.5 mm | 18 | 7.0 mm | 36 |
| 2X Wall Thickness |
≤ 1.4 mm for All Device Sizes | |||
To determine if the saphenous vein wall thickness is acceptable:
1. Empty the saphenous vein of all fluid and air.
2. With the SIZING TOOL at a 90° angle to the saphenous vein, attempt to slide the emptied saphenous vein into the 2X WALL slot on the SIZING TOOL.
To determine the size of eSVS Mesh to use:
1. Confirm that the saphenous vein has acceptable wall thickness, as described above. If it does, inflate the vein graft with heparinized blood or physiologic crystalloid solution using sufficient pressure to completely fill, but not over-distend, the vein graft.
2. Insert the inflated vein graft into each slot of the SIZING TOOL in a caliper-like manner moving from smallest to largest sizing slot (excluding 2X WALL slot). The smallest slot in which the vein graft fits without any diameter deformation identifies by size and color the size of eSVS Mesh to use. If the vein graft fits into the smallest slot on the SIZING TOOL without deformation or is deformed by the largest slot on the tool, do not use the eSVS Mesh on the vein graft.
- Empty the vein graft of all fluid and air.
- Ligate the distal end of the vein graft with a heavy tie or suture (2-0 or larger) leaving a suture tail longer than the length of the eSVS Mesh DELIVERY TUBE.
- Push the ends of the eSVS Mesh toward the center of the DELIVERY TUBE.
- Pass the SUTURE SNARE through the lumen of the DELIVERY TUBE. Hook the long suture tail with the SUTURE SNARE and pull the suture through the lumen of the DELIVERY TUBE.
NOTE: Take care to ensure that the SUTURE SNARE is drawing the suture tail into the FLARED END of the DELIVERY TUBE. The eSVS Mesh can only be delivered onto a saphenous vein over the FLARED END of the DELIVERY TUBE.
- Wet the vein graft and the inside of the DELIVERY TUBE with physiologic crystalloid solution.
- Have an assistant firmly hold or anchor the proximal end of the vein graft. Grasp the end of the long suture tail and pull the vein graft taut ensuring that it lies without twist.
- With the thumb and forefinger of the opposite hand, grasp the end of the DELIVERY TUBE furthest from the vein graft and push the DELIVERY TUBE over the vein graft to the proximal cannula tip. Avoid any twisting or excessive stretching of the vein.
- Push 2-3 mm of the eSVS Mesh off the FLARED END of the DELIVERY TUBE and over the cannula tip.
- Secure the end of the eSVS Mesh to the cannula tip with heavy suture.
- While maintaining tautness on the vein graft, deploy the eSVS Mesh by pulling the DELIVERY TUBE straight away from the cannula tip (Caution: Do not twist the DELIVERY TUBE or the vein graft). This action fully extends the knit of the eSVS Mesh as it rides over and off the end of the DELIVERY TUBE. Should the eSVS Mesh become stuck on the DELIVERY TUBE, cease pulling the tube and push the remaining eSVS Mesh up the tube towards the deploying end until it becomes slightly compressed. Resume deployment by pulling the DELIVERY TUBE away from the cannula tip. Continue pulling the DELIVERY TUBE until the eSVS Mesh is completely deployed.
- With the eSVS Mesh fully deployed, clamp the distal end of the vein graft with a small locking hemostatic forceps (e.g. mosquito or Kelly). Cut off any excess eSVS Mesh and discard.
- Inflate the vein graft with heparinized blood or physiologic crystalloid solution until the vein graft wall is fully pressed against the eSVS Mesh.
- Dry the external surface of the eSVS Mesh/vein graft with a sterile lap sponge or towel.
- The method of oversewing/ligation of the side branches of the vein graft may increase the risk of bleeding, therefore, use TISSEEL Fibrin Sealant as an adjunct to hemostasis. Prepare 2-5 ml of TISSEEL along with the accessory components and equipment for gas assisted application per Manufacturer’s Instructions for Use. Take preparation time into account.
- Apply a thin layer of TISSEEL fibrin sealant to the surface of the eSVS Mesh/vein graft, ensuring that all areas containing side branches are coated.
- Allow the TISSEEL to cure 3-5 minutes, per the TISSEEL Instructions for Use.
- Remove the hemostatic forceps and cut the distal end of the eSVS Mesh/vein graft with scissors to the desired angle for coronary anastomosis.
NOTE: The vein graft edge may retract slightly into the eSVS Mesh. Trim back the edge of the eSVS Mesh, if necessary, to ensure the vein graft edge is even with, or extends slightly beyond the eSVS Mesh edge.
- Flush the graft well with heparinized blood or physiologic crystalloid solution to expel any possible debris from the eSVS Mesh/vein graft lumen.
- Anastomose the eSVS Mesh/vein graft to the target coronary artery using standard suturing technique. One row of eSVS Mesh should be incorporated into the suture line of the anastomosis.
- Clamp the eSVS Mesh/vein graft, as necessary, using an atraumatic spring clamp (e.g. bulldog). Do not clamp the eSVS Mesh/vein graft with a locking forceps.
- Cut the eSVS Mesh/vein graft to length so that it lies without tension or twist. Cut the proximal end of the eSVS Mesh/vein graft to the desired angle for aortic anastomosis.
NOTE: The vein graft edge may retract slightly into the eSVS Mesh. Trim back the edge of the eSVS Mesh, if necessary, to ensure the vein graft edge is even with, or extends slightly beyond the eSVS Mesh edge. Ensure no trimmings fall into the eSVS Mesh/vein graft lumen. CAUTION: Ensure that the “heel” of the eSVS Mesh/vein graft has a longitudinal notch or slit, the length of which is equal to or greater than the diameter of the graft. Also ensure that the diameter/circumference of the trimmed graft opening is at least 20% larger than the aortic opening, in order to form an adequate “hood” at the site of the proximal anastomosis. Failure to do so can result in a “flattening” of the graft at the proximal anastomotic site, which may compromise the graft lumen.
- Anastomose the eSVS Mesh graft to the aorta using standard suturing technique. One row of eSVS Mesh should be incorporated into the suture line of the anastomosis.
- Remove air from the eSVS Mesh/vein graft using standard technique.
KIPS BAY MEDICAL, Inc. warrants that reasonable care has been used in the design and manufacture of this instrument. This warranty is in lieu of and excludes all other warranties not expressly set forth herein, whether express or implied by operation of law or otherwise, including, but not limited to, any implied warranties of merchantability of fitness for a particular purpose. Handling, storage, cleaning and sterilization of this instrument as well as other factors relating to the patient, diagnosis, treatment, surgical procedures, and other matters beyond KIPS BAY MEDICAL’s control directly affect the instrument and the results obtained from its use. KIPS BAY MEDICAL’s obligation under this warranty is limited to the repair or replacement of this instrument and KIPS BAY MEDICAL shall not be liable for any incidental or consequential loss, damage, or expense directly or indirectly from the use of this instrument. KIPS BAY MEDICAL neither assumes, nor authorizes any other person to assume for it, any other or additional liability or responsibility in connection with this instrument. KIPS BAY MEDICAL assumes no liability with respect to instruments reused, reprocessed or resterilized and makes no warranties, express or implied, including but not limited to merchantability or fitness for a particular purpose, with respect to the instrument.
Caution: Investigational Device Limited by Federal (or United States) law to investigational use
This device is commercially available for use in select international markets
* Tisseel/Tissucol are registered Trademarks of Baxter Healthcare Corp. For full prescribing information please see: http://www.tisseel.com/us/pdf/2012-0125_PI_TISSEEL_.pdf
