CryoLife HeRo GRAFT Mode D'emploi page 8

6. Reclamp the Arterial Graft Component.
NOTE: Avoid beaded region of Arterial Graft Component.
7. Attach a syringe with heparinized saline to the Arterial Graft Component using a syringe adapter. Remove the clamp and flush
the entire HeRO Graft. Observe the DPG connection site for leakage. Reclamp the Arterial Graft Component.
Caution: If leakage is observed, check for proper connection of the Arterial Graft Component to the Venous Outflow
Component.
ARTERIAL GRAFT COMPONENT AND ARTERY CONNECTION
1. Cut the Arterial Graft Component to length, avoiding excessive tension or excess material. Verify there are no kinks, twists, or
bends in the Arterial Graft Component.
2. Perform the arterial anastomosis utilizing standard surgical techniques.
Caution: Use a small diameter tapered needle with a non-cutting edge to reduce the incidence of suture hole bleeding.
3. Remove the clamp and check the device patency utilizing standard Doppler technique.
4. Verify thrill and bruit.
5. Evaluate for steal syndrome during the implant procedure with Doppler of the radial and ulnar arteries. If steal syndrome
symptoms occur, consider surgical interventions such as:
• DRIL (distal revascularization-interval ligation) procedure
• Banding, though this may reduce the flow in the HeRO Graft
• Proximalization of the inflow
6. Close all three incision sites.
POST IMPLANT INFORMATION
1. Complete the Implant Notification Fax Form in the Patient Information Pouch and fax the completed form to the patient's dialysis
center.
2. Provide the patient with the remaining items in the Patient Information Pouch.
VASCULAR ACCESS CANNULATION
Follow KDOQI guidelines for graft assessment, preparation and cannulation.
• The Arterial Graft Component requires 2-4 weeks to incorporate prior to cannulation.
• Swelling must subside enough to allow palpation of the entire Arterial Graft Component.
• Rotation of cannulation sites is needed to avoid pseudoaneurysm formation.
• A light tourniquet may be used for cannulation as the thrill and bruit may be softer than a conventional ePTFE graft due to the
elimination of the venous anastomosis.
Post-dialysis, and following needle removal, apply moderate digital pressure at the puncture site until hemostasis is achieved. To
decrease the risk of an occlusion, do not use mechanical clamps or straps.
Caution: DO NOT cannulate the HeRO Graft within 8cm (3") of the DPG incision to avoid damage to the beaded section
of the Arterial Graft Component.
Caution: DO NOT cannulate the Venous Outflow Component.
Caution: Remove the bridging catheter as soon as possible once the HeRO Graft is ready to be cannulated to decrease
the risk of an infection related to the bridging catheter.
Caution: All bridging catheters should be cultured upon explant. In the event catheter tip cultures are positive, treat the
patient with appropriate antibiotics to decrease the risk of the HeRO Graft becoming infected.
For additional information refer to the HeRO Graft Care & Cannulation Guide in the patient information or review online at
www.herograft.com.
PERCUTANEOUS THROMBECTOMY
The HeRO Graft will require maintenance equivalent to conventional ePTFE grafts. The HeRO Graft can be up to 90cm long; thus
requiring a longer thrombectomy device to traverse the entire length of the device.
Caution: Do not use mechanical/rotational thrombectomy devices (e.g., Arrow-Trerotola PTD®) in the Venous Outflow
Component and/or connector as internal damage may occur to these components.
For specific thrombectomy instructions or guidance, please contact Customer Service for a copy of the Thrombectomy Guidelines
or it may also be found on www.herograft.com.
DEVICE EXPLANT, EXCHANGE, REVISION OR ABANDONMENT
The HeRO Graft Venous Outflow Component and connection portion should be removed if the device will not be used for
hemodialysis access. In situations where the HeRO Graft requires exchange, explant or revision, please contact Customer Service
for an instruction procedure and an Explant Return Kit. Instructions may also be found in the Frequently Asked Questions section
of www.herograft.com.
MRI INFORMATION
The HeRO Graft was determined to be 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 has demonstrated that the HeRO Graft 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
• Spatial gradient magnetic field of 720-Gauss / cm or less
MRI-Related Heating
In non-clinical testing, the device produced the following temperature rise during MRI performed for 15-min in the 3-Tesla (3-Tesla
/ 128-MHz, Excite, Software G3.0-052B, General Electric Healthcare, Milwaukee, WI) MR system: Highest temperature change
+1.6°C.
Therefore, the MRI-related heating experiments for the device at 3-Tesla using a transmit / receive radiofrequency (RF) body coil
at an MR system reported whole body averaged SAR of 3.0-W / kg (i.e., associated with a calorimetry measured value of 2.8-W
/ kg) indicated that the greatest amount of heating that occurred in association with these specific conditions was equal to or less
than +1.6°C.
Artifact Information
MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the
device. Therefore, optimization of MR imaging parameters to compensate for the presence of this device may be necessary.
Pulse Sequence
Signal Void Size:
Plane Orientation:
T1-SE T1-SE
2
7,849 mm 295 mm
Parallel Perpendicular
ENGLISH
GRE
2
9,519 mm
Parallel
8
GRE
2 2
1,273 mm
Perpendicular