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Table 5. aneurysm Size
Measurement
Dome width (mm)
Neck length (mm)
Dome to neck ratio
Parent vessel pre-aneurysm (mm)
Parent vessel post-aneurysm (mm)
Parent vessel caliber differential (mm)
The 29 patients were implanted with 39 stents to treat their 30 aneurysms. Twenty (69%) patients had 1 stent,
8 (28%) patients had 2 stents, and 1 (3%) patient had 3 stents. The stents implanted ranged from 3.5 mm to
4.5 mm. One patient required a secondary endovascular procedure to place a second stent in the correct
location because the original stent was inadvertently not deployed at aneurysm site; this counts for 2 of the
stents. One patient had the original stent successfully deployed but was removed during the embolic coiling
procedure when the clinical study investigator attempted to snare the errant coil loop and dislodged the stent.
A replacement stent was implanted in its place, and this counts for 2 of the stents. For 7 patients, multiple
stents were used to treat one aneurysm in cases where (1) the embolic coiling procedure left the tail of an
embolic coil in the vessel or (2) the neck of aneurysm was estimated at an incorrect width and a second or
third stent was necessary to cover the neck of the aneurysm.
With regard to patient accounting, 31 patients were originally entered into the study; however, 2 did not receive
the stent. One patient died immediately after the procedure. There are adverse event data on 29 patients,
including the one death. Therefore, there were 28 patients of 31 who were expected for evaluation through
6 months. At discharge, 28 of the expected 28 were evaluated for a follow-up rate of 100%. At 6 months, 26 of
28 patients were evaluated for a follow-up rate of 93%.
The study endpoints were (1) adverse events, (2) technical feasibility, and (3) clinical outcome. The incidence
of all adverse events, device or procedure-related, were assessed. Technical feasibility was assessed by the
ability to access the aneurysm and place the stent accurately across the aneurysm neck. Clinical outcome
was assessed by percent angiographic aneurysm occlusion.
Adverse events were presented in Tables 2 and 3 in the Adverse Events section above.
Table 6 below summarizes the patient rates with regard to technical feasibility.
Table 6. Technical Feasibility
Technical Feasibility
Ability to access aneurysm
Ability to place stent across aneurysm neck
Two patients could not be accessed based on anatomy.
1
One patient required a secondary endovascular procedure to place a second stent in the correct location because the original
2
stent was inadvertently not deployed at aneurysm site.
There were 2 intraoperative device malfunctions involving the markerband of the 2F Stabilizer Catheter inadvertently detaching
3
from the shaft of the 2F Stabilizer Catheter after stent deployment. In one patient, the 2F Stabilizer Catheter was inside the patient
at the time of the device malfunction, and the separated markerband embolized in a small, distal intracranial artery. This patient
had no adverse events from this event. In the second patient, the 2F Stabilizer Catheter was outside the patient at the time of the
device malfunction. Stryker Neurovascular has since increased its markerband bond strength.
Table 7 below summarizes the patient rates with regard to clinical outcome.
Table 7. Clinical Outcome
Clinical Outcome
1
% occlusion at discharge
2
100%
95-99%
% occlusion at 6 months
100%
95-99%
The "n" reflects the number of occurrences. The % is based on 29 patients at discharge and 26 patients at 6 months.
1
One patient had 2 aneurysms, each with different resulting % occlusion. Therefore, this patient is reported twice.
2
Black (K) ∆E ≤5.0
n
Mean
SD
Min
Max
30
7.4
4.3
2.1
20.0
30
4.9
1.8
2.1
11.0
30
1.5
0.5
0.8
2.7
30
3.6
0.6
2.4
4.8
30
3.2
0.7
1.7
4.4
30
1.0
1.0
0.3
1.7
n (%)
29/31 (93.5%) patients
1
29/29 (100%) patients
2,3
n (%)
17 (58.6%)
13 (44.8%)
18 (69.2%)
8 (30.8%)
Other clinical outcomes included:
• No stent stenosis or migration.
• No emboli coil migration.
• No parent vessel thrombosis, occlusion, or dissection.
• Neurological status: Of 26 patients evaluated at 6 months, 17 (65%) had an unchanged (normal)
neurological assessment as compared to baseline, 3 (16%) had an improved (from abnormal to normal)
neurological assessment as compared to baseline, 5 (19%) had an unchanged (abnormal) neurological
assessment as compared to baseline, and 1 (4%) had a worsened (abnormal moderate confusion to
abnormal severe confusion) neurological assessment as compared to baseline.
COnCOMITanT MEDICaL THEraPY
Typical antiplatelet and anticoagulation regimen used for interventional intracranial procedure is
recommended at the discretion of the treating physician. Do not use the Neuroform EZ™ Stent System in
patients in whom antiplatelet and/or anticoagulation therapy is contraindicated.
MrI InFOrMaTIOn
Magnetic resonance Conditional
Non-clinical testing and analysis have demonstrated that Neuroform™ Stent is MR Conditional alone, or when
overlapped with a second stent, and adjacent to a Stryker Neurovascular coil mass. A patient with Neuroform
Stent can be safely scanned immediately after placement of this implant, under the following conditions:
• static magnetic field of 1.5 and 3.0 Tesla
• spatial gradient field up to 2500 Gauss/cm (25 Tesla/m)
• normal operational mode for gradients and SAR (maximum whole body averaged specific absorption
rate (SAR) of lower than 2.0 W/kg and maximum head SAR of lower than 3.2 W/kg) for a total active MR
scan time (with RF exposure) of 15 minutes or less per scan sequence.
In an analysis based on the temperature rises in non-clinical testing of stents and the calculated SAR in the
patient during an MR scan, Neuroform Stents were determined to produce an in-vivo temperature rise of
4°C or lower for 15 minutes of MR scanning in normal operational mode in 1.5 T and 3 T MR systems. The
Neuroform Stent should not migrate in this MRI environment.
MR image quality may be compromised if the area of interest is in the same area or relatively close to the
position of the device. In Spin Echo and Gradient Echo sequence evaluations Neuroform stent image artifact
extended approximately 2 mm from the device. Lumen of the stent was partially obscured by the artifact.
Therefore, it may be necessary to optimize MR imaging parameters for the presence of this implant.
HOw SUPPLIED
Do not use if package is opened or damaged.
Do not use if labeling is incomplete or illegible.
Handling and Storage
Store in a cool, dry, dark place.
OPEraTIOnaL InSTrUCTIOnS
Initial access, angiographic assessment and Stent Selection
1. Gain vascular access according to standard practice. Select a Boston Scientific or Stryker Neurovascular
microcatheter (0.027 in / 0.69 mm ID and 135 or 150 cm length) with a neurovascular indication. Establish and
maintain continuous flush with sterile heparinized saline through the microcatheter per standard vascular
practice. Using angiography, determine the location of the aneurysm and the size of the aneurysm neck.
2. Navigate the microcatheter over an access length guidewire at least 1.2 cm distal to the aneurysm neck.
note: The microcatheter tip must be placed sufficiently distal to the aneurysm neck to allow for slack
to be removed from the system after the stent is advanced, while maintaining adequate stent length
(approximately 4 mm) distal to the aneurysm neck. Excessive tortuosity may necessitate microcatheter
tip placement more than 1.2 cm distal to the aneurysm neck.
3. Remove the guidewire.
4. Select an appropriate Neuroform EZ Stent System based on the sizing recommendations in Table 1
and based on the larger reference vessel diameter. Select a stent that is at least 8 mm longer than the
aneurysm neck to maintain a minimum of 4 mm on each side of the aneurysm neck along the parent vessel.
Delivery System Preparation and Stent Transfer
5. Carefully inspect the stent system packaging for damage. Do not use if damage is found; call your
Stryker Neurovascular representative.
6. Peel open the pouch using aseptic technique.
7. Carefully place the dispenser hoop into the sterile field.
8. Release the stent delivery wire from the clip on the dispenser hoop. Hold the stent delivery wire and
proximal end of the introducer sheath together, then carefully remove the system from the dispenser hoop.
4
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