Morris FISH Device User Manual
F I S H ™ S
Introducer
Closure Patch
Vessel Dilator
Guide wire
DEVICE P
FEMORAL INTRODUCER S HEATH & HEMOSTASIS
DEVICE
INSTRUCTIONS FOR USE
Read instructions before use.
Caution:
‘Federal law restricts this device for use by or on the order of a physician (or allied healthcare
professionals authorized by or under the direction of such physicians) who have been trained by an
authorized representative of MI, Inc. in the use of the FISH™ Device.”
CONTENTS:
Sheath with
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SYSTEM COMPONENTS / DESCRIPTION
A. Introducer Sheath with Closure Patch
The Femoral Introducer Sheath and Hemostasis Device (FISH™ Device) facilitates percutaneous entry of an
intravascular device and aids in reducing time to hemostasis and ambulation for femoral arterial access. French
sizes of the FISH™ Device indicated by color coding. Listed below are the two available French sizes and their
corresponding color.
FRENCH COLOR
6 (2.0 mm) Green
8 (2.7mm) Orange
B. Vessel Dilator
The vessel dilator atraumatically transitions the guide wire to the introducer sheath through a tapered tip, which
opens the tissue from the skin to the vessel below.
C. Guide Wire
The guide wire is provided to maintain access to the vessel upon removal of an 18 or 21 gauge introducer needle
during the insertion of the FISH™ Device.
NOTE: The introducer needle is not included in the kit, so a sterile 18 or 21 gauge needs to be provided by the user
according to preference.
INDICATIONS
The Femoral Introducer Sheath and Hemostasis device (FISH™ Device) is intended for hemostatic closure of the
femoral artery access sites. The system is indicated for use in reducing time to hemostasis and time to
ambulation in patients who have undergone diagnos tic procedures using 5, 6, 7, or 8 French procedural sheaths.
CONTRAINDICATIONS
This product should not be used in patients who have a known sensitivity or allergy to porcine derived material of
resorbable sutures.
WARNINGS
Do not use with Lipiodol contrast media, Ethiodal*, or contras t media that includes components of these agents.
Do not leave the FISH™ Device in the artery for prolonged per iods of time (> 24 hrs.) without an obturator or
catheter assisting and supporting the cannula wall.
The FISH™ Device is for one use only. The function and/ or performance of the device may be destroyed by
reusing, resterilizing, or cleaning the device. Additionally, adverse patient reactions may result. Morris
Innovative, Inc. will not be responsible for any damages or expenses that may result for reusing the
FISH™ device.
If the package of the FISH™ Device is damaged, stained, or appears tampered with/opened prior to use do not
use.
Do not autoclave. The introducer s heath and its components may be damaged by ex posure to temperatures
above 54° C (130° F).
Do not expose device to organic solvents.
*Thiokol is a trademark of Guerbet S.A.
PRECAUTIONS
Prior to use, make sure the French size is correct for the catheter to be used.
When the FISH™ Device is used, the entire procedure should occur aseptically.
A power injector should not be used through the 3-way stopcock to the side tube.
Note expiration date on the device, and do not use the device if it is labeled as being expired.
Store FISH™ devices in a dark, cool, dry place. A void humidity and direct sunlight.
Use of the FISH™ System in diagnostic patients has not been evaluated in patients receiving glycoprotein
IIb/IIIa inhibitors.
Do not use the FISH™ Device if the puncture is made through the posterior wall of the femoral artery or if there
are multiple punctures as such punctures may result in a retroperitoneal hematoma.
Special Patient Populations
The safety and effectiveness of the FISH™ Device has not been established in the following patient populations:
Patients who are pregnant or lactating
Patients who are < 18 or > 80 years of age
Patients with bleeding diathesis or known hypercoagu lable disorders
Patients with bleeding or platelet disorders
Patients having uncontrolled hyper tension (systolic BP > 180mmHg)
Patients having auto-immune disorders
Patients having vascular grafts at the puncture site
Patients receiving glycoprotein IIb/IIIa inhibitors
Patients with: Pseudoaneurysm, AV fistula, intraluminal thrombus, or arterial dissection present in the
ipsilateral femoral artery prior to arterial closure
Patients having intra-procedural bleeding around access site
Patients having a palpable ipsilateral hematoma of any size obs erved during the catheterization procedure
Patients developing absent pedal pulses in the ips ilateral lower extremity during the catheterization procedure
Patients needing a procedure requiring an introducer s heath size of > 8F or < 4F
Patients having arterial closure site depth > 7.5cm
Patients having ACT > 400 seconds at the time of introducer sheath removal
Adverse Effects of the Device on Health
The FISH™ System was evaluated in a randomized controlled clinical investigation involving 206 diagnostic
patients enrolled at 8 United States clinical sites; 139 subjects (67%) received the FISH™ Device and 67 subjects
received (33%) the control, Manual Compression (MC). Prior to enrollment of r andomized patients, each site
enrolled non-randomized roll-in patients for training purposes. There were a total of 19 roll-in patients in the
diagnostic study.
There was one (1) death reported during the randomized investigation, which w as not device-related. This patient
was randomized to the FISH™ device.
Closure method related adverse events seen in the clinical study were:
Hematoma
Bleeding Requiring Transfusion
Pseudoaneurysm Requiring Thrombin Injection
Potential complications of allergic reaction, adhesion formation, infection or abscess, foreign body reaction,
wound dehiscence, or vessel occlusion were not seen. The following table (Table 1) shows the adverse events
from the diagnostic clinical study.
Cumulative Major and Minor Complications – Blackwater Test for Equivalence
Randomized Subjects N = 206
FISH Device (n=139)
Manual Comp. (n=67)
p-value
**
% of patients
No. of
Events
% of patients
No. of
Events
95% CI*
95% CI*
Combined Major Complications
0.72% 1 0%
0
<0.0001
(0.02%, 3.94%)
(0.0%, 5.36%)
Access-site related bleeding requiring transfusion
0.72% 1 0
0
<0.0001
(0.01%, 2.88%)
(0.0%, 3.42%)
New ischemia in ipsilateral leg
0 0 0
0
-(0.0%, --)
(0.0%, --)
Vascular surgical repair, US-guided compression,
Transcatheter embolization, or stent graft
0 0 0
0
-(0.0%, --)
(0.0%, --)
Surgery for access-site related nerve injury
0 0 0
0
-(0.0%, --)
(0.0%, --)
Permanent access-site related nerve injury
0 0 0
0
-(0.0%, --)
(0.0%, --)
Access-site related infection requiring IV
antibiotics and/or extended hospitalization
0 0 0
0
-(0.0%, --)
(0.0%, --)
Combined Minor Complications
2.88% 4 1.49%
1
0.039
(0.79%, 7.20%)
(0.04%, 8.04%)
Access-site related hematoma > 6cm
2,16% 3 1.49%
1
0.012
(0.45%, 6.18%)
(0.04%, 8.04%)
Pseudoaneurysm treated with ultrasound-guided
thrombin injection
0.72% 1 0
0
<0.0001
(0.13%, 3.73%)
(0.02%, 5.14%)
Pseudoaneurysm treated with ultrasound-guided
fibrin adhesive injection
0 0 0
0
--
(0.0%, --)
(0.0%, --)
Non-treated pseudoaneurysm (documented by
ultrasound)
0 0 0
0
--
(0.0%, --)
(0.0%, --)
Non-treated AV fistula (documented by
ultrasound)
0 0 0
0
--
(0.0%, --)
(0.0%, --)
Device Success***
99%
--
--
--
--
137/139
--
Procedure Success****
100%
--
100%
--
--
139/139
67/67
Primary Effectiveness
Time to Hemostasis (Minutes)
FISH™
Manual Compression
p-value
N
138
67
< 0.0001
Mean (SD)
8.9 (6.65)
17.2 (6.7)
Median
6
17
Min – Max
2 - 40
7 – 55
Time to Ambulation (Hours)
FISH™
Manual Compression
p-value
N
130
65
<0.0001
Mean (SD)
2.4 (2.1)
4.3 (1.0)
Median
2.0
4.2
Min – Max
0.9 – 19.6
1.3 – 7.3
Secondary Effectiveness
Time to Eligible Discharge (Hours)
FISH™
Manual Compression
p-value
N
129
65
<0.0001
Mean (SD)
3.0 (3.1)
5.5 (4.0)
Median
2.3
4.5
Min – Max
1 – 22.4
1.5 - 24.2
Time to Discharge (Hours)
FISH™
Manual Compression
p-value
N
126
65
<0.0001
Mean (SD)
16.2 (43.1)
24.9 (53.1)
Median
3.0
4.9
Min – Max
1.5 - 263
3.4 – 217.9
Equivalence Study At 30 Days
Discomfort (Subjective Scale 0-10)
FISH™
Manual Compression
p-value
N
138
67
0.147
Mean (SD)
0.51 (1.5)
0.21 (1.0)
Median
0
0
Min – Max
0 - 8
0 – 6
Table 1 – Major and Minor Complications through 30 Days – Diagnostic ITT Patients
* Exact 95% confidence interval based on Clopper-Pearson method
** Blackwater’s test with an equivalent limit of 0.05. The significance level of 0.041 was used for the interim
*** Device Success – the ability to achieve hemostasis without major adverse events of the use of mechanical compression and
within the allotted time (60 minutes).
**** Procedure Success – the ability to establish hemostasis in a given subject within any time period using any method.
Table 1 shows that the overall MACE rates were 0.72% and 0.0% for FISH™ device and control group, respectively.
The overall Minor Adverse Event rates were 2.88% and 1.5% for the FISH device and control group respectively.
Clinical Studies
The FISH closure device was studied in an open-label, randomized, multi- center clinical trial which enrolled 297
diagnostic and interventional patients. This United States based trial evaluated the FISH device to manual
compression. The study included both diagnostic ( N=206) and interventional (N=91) patients requiring a
procedure with and 8Fr or smaller sheath size. The study of interventional patients with the FISH™ device is
currently ongoing. Data from the interventional study is not discussed here. Each investigator had the
opportunity to enroll up to 2 roll-in patients which were non r andomized patients. There were a total of 28 roll -in
patients combined in the diagnostic and interventional study. The patients were randomized on a 2 to 1
randomization scheme (FISH™ device vs. manual compression). Of the 206 diagnostic patients enrolled in the
study, 139 received the FISH™ device and 67 received manual compression.
This study included 8 U.S. sites and enrolled patients between January 2004 and June of 2006. There were a
total of 40 investigators which enrolled patients for the study.
All patients enrolled in the study provided a signed written informed consent and agreed to return for a follow-up
evaluation at 30 ± 5days. The study included patients who were undergoing diagnostic or therapeutic coronary or
peripheral procedure performed percutaneously via the common femoral artery. The candidates were required
to meet general inclusion and exclusion criteria. The patients did not require a femoral artery angiogram prior to
placement of the FISH Device.
The null hypothesis for safety was that the experimental device had a major adverse event rate that exceeded
that of the control by a delta of 5%. The alternate hypothesis was that the exper imental device has a pr imary
safety endpoint rate less than that of the control or exceeding that of the contr ol by no more than the delta 5%.
Null Hypothesis
MII FISH (%MACE) > Manual Compression (%MACE) + 5% delta
Alternative Hypothesis
MII FISH (%MACE) < Manual Compression (%MACE) + 5% delta
For the diagnostic patients, the FISH device demonstrated safety with a total adverse event rate of 0.7% (1/139)
versus the control 0.0% (0/67). The one event for the FISH device was a site related bleeding requiring
transfusion. These rates for MACE in the diagnostic patients were found to be equivalent (p < 0.0001) under the
experimental conditions outlined prospectively in the investigational plan.
The minor adverse event rate was low for both the FISH device (2 .9%) and the control (1.5%), the tests for
equivalence showed these to be equal (p=0.039). The events for the device include 3 hematomas > 6cm and 1
Pseudoaneurysm. For the control there was one hematoma > 6cm. During the course of this clinical trial ther e
was one patient death (1 FISH, 0 Manual Compression). The death was not related to the use of the device.
There were no Unanticipated Access Site Related Adverse Events.
Effectiveness Results
In all effectiveness endpoints the FISH device proved s uperior in diagnostic patients compared to the control
manual compression. The median time for hemostasis in the FISH patients was 6 minutes versus 17 minutes for
the control group manual compression. The median time for ambulation for the FISH device was 2 .0 hours for the
FISH group versus 4.2 hours for the control. The median time to eligible discharge for the FISH device was 2.3
hours versus 4.5 hours for the control. The median time to eligible discharge for the FISH device was 2.3 hours
versus 4.5 hours for the control manual compression. The median time to discharge was 3.0 hours for the FISH
patients versus 4.9 hours for the control group manual compression. The following table (Table 2) shows the
effectiveness results.
Table 2 – Diagnostic Procedures: Primary Effectiveness Results ITT
The effectiveness calculations were based on the Wilcoxon Two-Sample Test using a normal approximation and two-sided criteria
(Pr > Z < .0001).
The results of the statistical analyses demonstrate that the FISH™ device is superior to Manual Compression in
terms of effectiveness measures for vascular hemostasis, ambulation, eligible discharge, discharge and
equivalent relative to discomfort subjectively measured at 30 days post pr ocedure. The FISH device has
demonstrated safety through its low incidence of complications in diagnos tic patients when compared to manual
compression.
Effectiveness Endpoints
Time to Hemostasis (TTH) was measured from the time of introducer sheath pull to the time the patient
achieved hemostasis. For this study, the time of hemostasis was defined as “Absence of oozing blood that is
readily treated by light compression methods (e.g. sandbags, pressure dressing, light manual pressure)”. The
study was designed to demonstrate TTH superiority as compared to the control therapy.
Figure 1 Histogram of Percentage of Patients vs. Time to Hemostasis (in minutes)
Time to Ambulation (TTA) – this was measured from the time of introducer sheath removal to the time when
the patient stood at the bedside and walked at least 20 feet without evidence of re-bleeding. The study w as
designed to demonstrate TTA superiority as compared to the control therapy.
Figure 2 Histogram of Percentage of Patients vs. Time to Ambulation (in minutes)
Time to Eligible Discharge (TTED) – this was measured from the time of introducer sheath pull to the time when
the patient was deemed eligible for discharge from the hospital based onl y on the condition of the access site.
The study was designed to demonstrate TTED superiority as compared to the control therapy.
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