Merit Medical HERO GRAFT Mode D'emploi page 12

DEVICE EXPLANT, EXCHANGE, REVISION OR ABANDONMENT
The HeRO Graft Adapter, Support Seal (if applicable), and Venous Outflow Component 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 at 1-800-356-3748
for information and an Explant Return Kit. Instructions may also be found on www.merit.com/hero.
SUMMARY OF HeRO GRAFT CLINICAL EXPERIENCE
The HeRO Graft was evaluated in a prospective clinical study to demonstrate that the device raises no new concerns of safety and effectiveness when
used as indicated in patients requiring long-term hemodialysis.
The HeRO Graft was studied in two different patient populations. One was a prospective literature controlled study of HeRO Graft / implant
procedure-related bacteremia rates in catheter-dependent subjects (the "bacteremia study"),
patency in upper arm graft-eligible subjects compared to subjects receiving an ePTFE control graft (the "patency study").
Fourteen (14) institutions treated 86 subjects with the HeRO Graft. Subjects were required to return for post-operative evaluation at three-month
intervals for a minimum of 12 months. Endpoint and performance results are summarized in Table 3.
The study results show that the rate of device / procedure-related bacteremia associated with the HeRO Graft is statistically lower than reported
in the literature for tunneled catheters and comparable to that reported in the literature for conventional ePTFE grafts. HeRO Graft patency and
adequacy of dialysis are significantly improved compared to catheter literature and comparable to graft literature.
The HeRO Graft has an associated safety profile that is comparable to existing graft and catheters used for hemodialysis. In this study, no new
concerns of safety and effectiveness for a long-term vascular access device were observed. There were no unanticipated events. Serious HeRO Graft
and / or procedure-related adverse events by type are summarized in Table 4.
Device-related adverse events occurred at a frequency comparable to both the catheter and graft literature with the exception of bleeding.
six (6) bleeding events in the patency study, two (2) were indirectly related to the HeRO Graft implant procedure; in the first patient, coagulopathy
was caused by other conditions and bleeding was not unexpected, and in the second patient, a heparin administrative error occurred. Three (3)
bleeding events were directly attributed to an earlier generation 22F HeRO Graft Venous Outflow Component, which required an internal jugular
venous cut-down. The sixth bleeding event was related to a HeRO Graft explant procedure. There was one (1) device-related death in the patency
study due to device-related sepsis complications, a known vascular access complication reported in the literature.
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.
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.
Table 4 Footnotes: 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.
TABLE 3: Final HeRO Graft Endpoint & Performance Data
from U.S. Multi-Center Pivotal Clinical Trials
HeRO Graft
Bacteremia Study
(N=36)
5
0.70/1,000 days
(1.45 Upper
Confidence Bound (UCB)) Confidence Bound (UCB))
47.2 (17/36)
94.4 (34/36)
77.8 (28/36)
33.3 (12/36)
88.9 (32/36)
77.8 (28/36)
1.7 ± 0.3 (N=25)
[1.2,2.4]
74.3 ± 3.8 (N=24) 72.8 ± 6.0 (N=21)
[65.3,83.0]
TABLE 4: 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)
5
2/2 (5.3%)
1/1 (2.6%)
0/0 (0.0%)
1/1 (2.6%)
1/1 (2.6%)
1/1 (2.6%)
0/0 (0.0%)
1/1 (2.6%)
0/0 (0.0%)
0/0 (0.0%)
1/1 (2.6%)
0/0 (0.0%)
1/1 (2.6%)
ENGLISH
HeRO Graft
Catheter
Patency Study
Literature
(N=50)
5
0.13/1,000 days
(0.39 Upper 2.3/1,000
48.0 (24/50) 50%
88.0 (44/50) 92%
78.0 (39/50) 55%
36.0 (18/50) 36%
84.0 (42/50) Not Reported
70.0 (35/50) 37%
1.6 ± 0.3 (N=33)
1.29 -1.46
[0.9,2.3]
65-70
[61.0,83.8]
HeRO Graft
Patency Study
# Events/
# Subject (%)
(N = 52)
5
6/6 (11.5%)
0/0 (0.0%)
1/1 (1.9%)
0/0 (0.0%)
1/1 (1.9%)
2/2 (3.8%)
1/1 (1.9%)
2/2 (3.8%)
1/1 (1.9%)
1/1 (1.9%)
0/0 (0%)
2/1 (1.9%)
8/5 (9.6%)
12
and the other was a randomized study of HeRO Graft
5
5
6, 7
ePTFE Graft
Literature
8 0.11/1,000
9
58%
8 8
68%
8 8
8 76% 8
8 42% 8
52%
8
65%
8 8
1.37-1.62
5 8
70-73
5 8
Catheter
Literature
5
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
Of the
6, 7
KDOQI Adequacy
of Hemodialysis
Guidelines
10
Not Applicable
Not Applicable
Not Applicable
Not Applicable
Not Applicable
Not Applicable
Not Applicable
1.4 target
70 target
ePTFE Graft
Literature
5
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