Acellular tissue engineered vessel

Administration Surgically implant SYMVESS under appropriate aseptic conditions. Follow the steps below for implantation of SYMVESS: When handling SYMVESS, avoid using excessive force, which may lead to SYMVESS damage. To avoid damage or contamination, always use sterile gloves and atraumatic instruments when handling SYMVESS.

Always protect SYMVESS from damage by heavy or sharp instruments. When necessary, a SHEATH TUNNELER may be used to safely deliver SYMVESS through subcutaneous or other tissues. Create a tissue tunnel that closely matches SYMVESS diameter (6 mm tunneller is recommended, but 8 mm tunneller is acceptable). A KELLY-WICK OR NON-SHEATHED TUNNELLER IS NOT RECOMMENDED FOR USE WITH SYMVESS .

During the tunneling process, ensure that SYMVESS does not kink or twist within the tunnel. A twisted or kinked vessel will result in compromised flow and performance, thereby increasing the risk of thrombosis and failure. It is recommended to keep the inner silicone tube in place within SYMVESS until any tunneling process is complete.

Lubricate the lumen of the tunneller sheath with saline solution and then gently push SYMVESS with the silicone tube through the sheath (alternatively SYMVESS can be grasped by or secured to the inner sheath rod and pulled through the sheath). After the tunneling sheath is removed, the inner silicone tube is removed from SYMVESS.

THE INNER SILICONE TUBE MUST BE REMOVED BEFORE CREATING AN ANASTOMOSIS ( FIGURE 9 ) Figure 9: Remove the inner silicone tube within the lumen of SYMVESS BEFORE creating an anastomosis. Following standard surgical procedures, the appropriate length to use for SYMVESS must be carefully determined. SYMVESS DOES NOT ELONGATE UNDER PRESSURE.

Since SYMVESS does not elongate, the length must allow SYMVESS to adequately reach both anastomoses. SYMVESS should either be tunneled or held at the site of implantation so that the length to adequately reach both anastomoses is clear. The patient’s body size and posture, and the range of the motions likely to be encountered around the anatomical region of the implantation should be considered when determining length.

Choosing the appropriate length of SYMVESS may prevent kinking, twisting, or damaging SYMVESS after implantation. Failure to carefully cut SYMVESS may cause damage and result in failure at the anastomosis site or reduced suture retention strength. Cut SYMVESS with sharp vascular scissors as one would trim a human blood vessel prior to implantation.

SYMVESS can be held with atraumatic instruments or sterile gloves while cutting with vascular scissors. The anastomosis must be precise, and with meticulous attention to detail. SYMVESS may be anastomosed end-to-end or end-to-side with the patient’s vessels. An end-to-side anastomosis may accommodate size discrepancies between the host vessel and SYMVESS.

Use of an appropriate anastomotic angle may minimize stresses upon SYMVESS which may reduce kinking and/or mechanical disruptions of SYMVESS, recipient or donor vessel, and/or suture lines. Use of non-crushing vascular (atraumatic) clamp is recommended on SYMVESS to avoid mechanical damage or disruption to SYMVESS. AVOID REPEATED, LOCALIZED CLAMPING OR EXCESSIVE CLAMPING ON ANY SECTION OF SYMVESS.

Use only 5-0 or 6-0 non-absorbable, monofilament suture with size selected based on the nature of the anastomosis. Use of a suture size larger in diameter than 5-0 or smaller in diameter than 6-0 for anastomosis creation with SYMVESS may reduce suture retention. A suture bite depth of 2.0-2.5mm is recommended to ensure suture retention.

Flush static blood from the lumen of SYMVESS while completing the second anastomosis. Failure to do so may result in thrombosis of the vessel. Undue anastomotic bleeding may occur if gaps are present between SYMVESS and the host vessel. Use appropriate suture placement and avoid undue tension on the suture line. Topical hemostatic agents may be used to minimize anastomotic bleeding if desired, therefore, the use of these agents will be at the surgeon’s discretion.

Inspect the operative site carefully prior to closure. Ensure that SYMVESS is covered by healthy muscle and/or soft tissue. Ensure that there are no twists, kinks, redundancy, before and during the tissue closure portion of the case. It may be necessary to clear or release tissue to avoid SYMVESS impingement. At the conclusion of the operation, inspect the circulation to ensure that perfusion to the distal vascular bed has not been compromised and assess for risk of compartment syndrome following revascularization.

Surgical interventions are permissible and up to the surgeon’s discretion. PERCUTANEOUS INTERVENTIONS SHOULD ONLY USE BALLOONS THAT DO NOT EXCEED 6MM IN DIAMETER . Larger diameter balloons used for angioplasty or thrombectomy procedures may result in tearing of the SYMVESS wall or development of pseudoaneurysm. Mechanical thrombectomy devices other than balloons have not been studied with SYMVESS in the trauma setting and therefore are not recommended.

Figure Q