CryoLife HeRo GRAFT Mode D'emploi page 4

Device/Procedure-Related
Bacteremia Rate/1,000 Days I
Primary Patency at
6 Months % (n/N)
Assisted Primary Patency at
6 Months % (n/N)
Secondary Patency at
6 Months % (n/N)
Primary Patency at 12
Months % (n/N)
Assisted Primary Patency at
12 Months % (n/N)
Secondary Patency at 12
Months % (n/N)
Kt/V
Adequacy
of Dialysis ±SD
[Min,Max]
URR
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
Bleeding, hemorrhage or
hematoma
Cardiac arrhythmia
Death
Edema
(includes swelling)
Pulmonary embolism
Infection
(non-bacteremia)
Stroke
Vascular insufficiency
due to steal syndrome
(includes ischemia)
Site pain
Trauma to major veins,
arteries, nerves
Wound problems
(includes wound
dehiscence)
Breakage or mechanical
failure (prosthesis
technical failure)
Other
VI
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
In addition to the Accessory Component Kit, 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
• Various atraumatic vascular clamps (for the Arterial
Graft 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.
TABLE 1: Final HeRO Graft Endpoint & Performance Data
from U.S. Multi-Center Pivotal Clinical Trials
HeRO Graft
Bacteremia Study Patency Study
(N=36)
3
0.70/1,000 days 0.13/1,000 days
(1.45 Upper (0.39 Upper
Confidence Bound Confidence Bound
(UCB)) (UCB))
47.2 (17/36) 48.0 (24/50)
94.4 (34/36) 88.0 (44/50)
77.8 (28/36) 78.0 (39/50)
33.3 (12/36) 36.0 (18/50)
88.9 (32/36) 84.0 (42/50)
77.8 (28/36) 70.0 (35/50)
1.7 ± 0.3 (N=25) 1.6 ± 0.3 (N=33)
[1.2,2.4] [0.9,2.3]
74.3 ± 3.8 (N=24) 72.8 ± 6.0 (N=21)
[65.3,83.0] [61.0,83.8]
Adverse Events by Type from U.S. Multi-Center Clinical Trials
HeRO Graft
Bacteremia Study #
Events I /
# Subject II (%) III
(N = 38)
3
2/2 (5.3%) 6/6 (11.5%)
1/1 (2.6%) 0/0 (0.0%)
0/0 (0.0%) 1/1 (1.9%)
1/1 (2.6%) 0/0 (0.0%)
1/1 (2.6%) 1/1 (1.9%)
1/1 (2.6%) 2/2 (3.8%)
0/0 (0.0%) 1/1 (1.9%)
1/1 (2.6%) 2/2 (3.8%)
0/0 (0.0%) 1/1 (1.9%)
0/0 (0.0%) 1/1 (1.9%)
1/1 (2.6%) 0/0 (0.0%)
0/0 (0.0%) 2/1 (1.9%)
1/1 (2.6%) 8/5 (9.6%)
ENGLISH
HeRO Graft
Catheter
(N=50) Literature
3
2.3/1,000
7
50%
7
92%
7
55%
7
36%
7
Not Reported
37%
7
1.29 -1.46
3
65-70
3
HeRO Graft
Patency Study
# Events/
# Subject (%)
(N = 52)
3
4
ePTFE Graft
Literature
0.11/1,000
6
58%
7
68%
7
76%
7
42%
7
52%
7
65%
7
1.37-1.62
3
70-73
3
Catheter
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
KDOQI Adequacy
of Hemodialysis
Guidelines
Not Applicable
Not Applicable
Not Applicable
Not Applicable
Not Applicable
Not Applicable
Not Applicable
1.4 target
2
70 target
2
ePTFE Graft
Literature
3
76/1587 (4.8%)
30/432 (6.9%)
of ESRD subjects
18.6% (327/1754)
IV
32/222 (14.4%)
28/686 (4.1%)
of ESRD subjects
9.8% (260/2663)
V
0.08-0.088/per year
in ESRD subjects
47/1229 (3.8%)
Not Reported
7/93 (7.5%)
3/129 (2.3%)
Not Reported
Not Reported