Merit Medical Hero Graft Instrucciones De Uso página 3

TABLE 1: Final HeRO Graft Endpoint & Performance Data
from U.S. Multi-Center Pivotal Clinical Trials
HeRO Graft HeRO Graft
Bacteremia Study Patency Study
(N=36) 3
Device/Procedure-Related 0.70/1,000 days 0.13/1,000 days
Bacteremia Rate/1,000 (1.45 Upper (0.39 Upper
Days I
Confidence Bound (UCB)) Confidence Bound (UCB))
Primary Patency at
47.2 (17/36) 48.0 (24/50)
6 Months % (n/N)
Assisted Primary
Patency at
94.4 (34/36) 88.0 (44/50)
6 Months % (n/N)
Secondary Patency at
77.8 (28/36) 78.0 (39/50)
6 Months % (n/N)
Primary Patency at 12
33.3 (12/36) 36.0 (18/50)
Months % (n/N)
Assisted Primary Patency
88.9 (32/36) 84.0 (42/50)
at 12 Months % (n/N)
Secondary Patency at 12
77.8 (28/36) 70.0 (35/50)
Months % (n/N)
1.7 ± 0.3 (N=25) 1.6 ± 0.3 (N=33)
Kt/V
Adequacy
[1.2,2.4] [0.9,2.3]
of Dialysis ±SD
74.3 ± 3.8 (N=24) 72.8 ± 6.0 (N=21)
[Min,Max] URR
[65.3,83.0] [61.0,83.8]
I. Procedure-related bacteremia was defined as any bacteremia seeded by the subject's previous tunneled dialysis catheter (cultured at the time of HeRO Graft implant), any bacteremia that may
have been seeded by a pre-existing infection elsewhere in the subject's body possibly making the subject more susceptible to bacteremia in the peri-operative period, or where there is no other
source for the bacteremia identified other than the implant procedure. Bacteremia was categorized as device-related when no other source for the infection could be identified.
TABLE 2: Final HeRO Graft Serious Device and/or Implant Procedure-Related
Adverse Events by Type from U.S. Multi-Center Clinical Trials
HeRO Graft
Bacteremia Study #
Events I /
# Subject II (%) III
(N = 38) 3
Bleeding, hemorrhage
2/2 (5.3%) 6/6 (11.5%)
or hematoma
Cardiac arrhythmia 1/1 (2.6%) 0/0 (0.0%)
Death 0/0 (0.0%) 1/1 (1.9%)
Edema
1/1 (2.6%) 0/0 (0.0%)
(includes swelling)
Pulmonary embolism 1/1 (2.6%) 1/1 (1.9%)
Infection
1/1 (2.6%) 2/2 (3.8%)
(non-bacteremia)
Stroke
0/0 (0.0%) 1/1 (1.9%)
Vascular insufficiency
due to steal syndrome 1/1 (2.6%) 2/2 (3.8%)
(includes ischemia)
Site pain 0/0 (0.0%) 1/1 (1.9%)
Trauma to major veins,
0/0 (0.0%) 1/1 (1.9%)
arteries, nerves
Wound problems
(includes wound 1/1 (2.6%) 0/0 (0.0%)
dehiscence)
Breakage or mechanical
failure (prosthesis
0/0 (0.0%) 2/1 (1.9%)
technical failure)
Other
VI 1/1 (2.6%) 8/5 (9.6%)
This table includes all enrolled HeRO Graft subjects including the 4 that did not receive the device.
I. Total number of events; II. Subjects with at least one event; III. Percent of subjects with at least one event; IV. Literature reports all deaths and not just device or procedure-related deaths; V. Graft
literature reports all infections including bacteremia or sepsis; VI 'Other' serious device and/or procedure related events included right atrial clot, hypotension with fever, non-sustained mild and
ventricular tachycardia, pneumonia, cardiogenic shock, hypoxia, hyperkalemia, hypoxemia, elevated white blood cell count.
In some instances, a direct comparison between the HeRO Graft data and the literature cannot be made because the only literature data available is reported per the overall ESRD population
vs specific catheter or graft populations. Additionally, some catheter literature data is only appropriate to report per catheter rather than per subject such as procedure related adverse events.
PROCEDURE ACCESSORIES
Accessory Component Kit
In addition to the , some vascular access surgical instruments may be required.
Vascular access surgical instruments including, but not limited to, the following:
• 5F micro-puncture set
• Various 0.035" guidewires at least 150cm in length
• Heavy duty scissors
• Heparinized saline
• 4 x 4 sterile gauze pads
• Various subcutaneous tissue & skin sutures
• Radiographic contrast fluid
• Tissue tunneler set with 6 mm & 7 mm bullet tips
Arterial Graft
• Various atraumatic vascular clamps (for the
Component)
• Standard vessel loops
• Syringe & syringe adapter
• Sterile surgical lubricant
• Access needles
PATIENT SELECTION CONSIDERATIONS
The following patient considerations should be evaluated prior to initiating the implant procedure:
1. Ensure proper patient selection via vessel mapping.
a) If vessel mapping indicates that a viable fistula or graft can be placed, consider these options first.
b) The target artery must have an ID of at least 3 mm to provide adequate arterial inflow to support the graft.
2. Verify the ejection fraction is greater than 20%.
ENGLISH
Catheter ePTFE Graft
(N=50) 3 Literature Literature
2.3/1,000 0.11/1,000
7 6
50% 7 58% 7
92% 7 68% 7
55% 7 76% 7
36% 42%
7 7
Not Reported 52%
7
37% 7 65% 7
1.29 -1.46 3 1.37-1.62 3
65-70 3 70-73 3
HeRO Graft
Patency Study
# Events/
# Subject (%) Catheter
(N = 52) 3 Literature 3
79/4209 (1.9%)
per Catheter
30/432 (6.9%)
of ESRD subjects
21% (249/1200)
IV
5/86 (5.8%)
per Catheter
28/686 (4.1%)
of ESRD subjects
1.6/1,000 days
0.08-0.088/per year
in ESRD subjects
Not Applicable
Not Reported
101/2823 (3.6%)
per Catheter
Not Reported
278/2214 (12.6%)
per subjects
Not Reported
4
3. Verify the systolic blood pressure is at least 100 mmHg.
4. Obtain screening blood cultures to rule out asymptomatic bacteremia prior to HeRO Graft implant for any patient dialyzing on a catheter; treat patient
with antibiotics per culture outcome and ensure infection is resolved prior to HeRO Graft implant procedure.
KDOQI Adequacy 5. Swab the patient's nose prior to HeRO Graft implant for potential methicillin resistant staphylococcus aureus; treat accordingly.
of Hemodialysis
Guidelines
Not Applicable
Not Applicable
Not Applicable
Not Applicable
Not Applicable
6. As with conventional grafts, HeRO Graft may occlude in patients with:
Not Applicable • A small brachial artery (e.g., ID less than 3mm)
• Insufficient arterial inflow or inflow stenosis
Not Applicable • A history of clotted accesses for unknown reasons
• A coagulability disorder or medical condition that is associated with clotting (i.e., cancer)
1.4 target 2
• Insufficient anticoagulation or non-compliance with anticoagulation medication
• Systemic low blood pressure or severe hypotension following fluid removal post dialysis
70 target 2
• A kinked graft
• Incomplete thrombus removal in previous interventions
• Intra-graft stenosis at site of multiple punctures
• An event such as mechanical compression (i.e., spring loaded hemostasis clamps)
Thrombosis is the most common cause of vascular access dysfunction. Missed hemodialysis sessions significantly increase the number of thrombosis
episodes in AVFs and AVGs.
HeRO GRAFT IMPLANT PROCEDURE GAINING VENOUS ACCESS
1. Equip a standard operating room with fluoroscopic and ultrasound guidance and prep the patient according to standard surgical guidelines for a vascular access
procedure.
ePTFE Graft
2. Pre-plan the surgical implant utilizing a surgical marker to indicate appropriate incisions and tunneling paths. Draw the HeRO Graft routing path in a soft C
Literature 3
configuration on the upper arm.
76/1587 (4.8%)
3. If choosing to utilize an existing tunneled catheter tract, use standard over-the-wire exchange techniques to remove catheter.
30/432 (6.9%) Accessory Component Kit
4. Open the
of ESRD subjects
Caution: Use a separate tray for removal of the existing tunneled catheter to aid in sterile preservation.
18.6% (327/1754)
IV
Culture any catheters removed at time of implant.
32/222 (14.4%)
Caution: Suture the tract closed from the existing catheter to HeRO Graft tract.
28/686 (4.1%)
Caution: Cover any catheter extensions with antimicrobial incise drape covering to protect the sterile area.
of ESRD subjects
Caution: Plan for increased bacteremia risk after an ipsilateral HeRO Graft placement or with femoral
9.8% V (260/2663)
bridging catheters and treat prophylactically with antibiotics knowing patients are at higher
infection risk.
0.08-0.088/per year
in ESRD subjects
Caution: Apply antibiotic ointment to the bridging catheter exit site.
5. Prophylactically treat the patient in the peri-operative period with antibiotics based upon the patient's bacteremia history:
47/1229 (3.8%)
• Ancef or combination Vancomycin and Gentamycin for native stick Venous Outflow Component placement
• Vancomycin and Gentamycin for over-the-wire exchange of a tunneled cuffed dialysis catheter
Not Reported
• Vancomycin and Gentamycin for femoral catheter placement and atypical HeRO Graft placement
7/93 (7.5%)
6. Using ultrasound guidance, gain percutaneous access to the venous system utilizing a 5F micropuncture set and standard Seldinger technique.
Caution: Use of the HeRO Graft was clinically studied utilizing the Internal Jugular vein. Central venous
3/129 (2.3%)
access through any other veins, for example, the subclavian vein, has NOT been studied and may
increase the risk of adverse events not encountered in the clinical trial. When using the subclavian
vein for venous access, a more lateral percutaneous approach might mitigate the risk of clavicle
Not Reported
crush or occlusion of the Venous Outflow Component. Consideration should be made to follow these
Not Reported patients with clavicle imaging to monitor the potential of interaction of the clavicle and first rib
with the Venous Outflow Component.
7. Using fluoroscopic guidance, advance a 0.035" guidewire, at least 150cm in length, to the inferior vena cava (IVC).
Caution: Maintain wire placement throughout the implantation of the Venous Outflow Component.
8. If performing venography to diagnose venous anatomy, select a appropriately sized introducer sheath.
9. Create a small incision at the exit site of the guidewire to aid in placement of the introducer sheath.
IMPLANTING THE VENOUS OUTFLOW COMPONENT
1. For patients undergoing general anesthesia, consider Trendelenburg position. Additionally, anesthesia personnel should force a positive breath to reduce the
potential for air embolus during implant.
NOTE:
For conscious sedation patients, utilize the Valsalva maneuver to reduce air embolus potential.
2. Based upon venous anatomy, determine if serial dilation is required. If so, utilize the 12F and 16F dilators as needed for pre-dilation of the venous tract prior to
inserting the 20F introducer.
NOTE:
Balloon angioplasty may also be required for severely stenosed anatomy.
NOTE:
Do not bend introducer sheath or dilator or use them to bypass stenosis.
3. Insert the short 20F introducer from the
accesses.
NOTE:
Use of the shorter introducer may help prevent kinking since it cannot be advanced as far into the vessel.
4. Advance the dilator and sheath together over the guidewire into the vessel using a twisting motion.
NOTE:
Do not insert the sheath/dilator too far. The tabs must extend well outside the body.
Venous Outflow Component
5. Open the
Venous Outflow Component
6. Flush the
7. Apply sterile surgical lubricant to the 10F delivery stylet and advance through the silicone Luer End of the
ENGLISH
8
using aseptic technique and prep the contents for use.
9
Accessory Component Kit
over the guidewire. The long 20F introducer may be used if needed for atypical
using aseptic technique.
with heparinized saline.
5
Venous Outflow Component
.