Cordis PRECISE PRO RX Gebrauchsanleitung Seite 8

PPE Specification
Labeling Specification
Precure Pro Rx OUS Carotid IFU
• Myocardial infarction
• Pain
• Pseudoaneurysm
• Renal failure
• Restenosis of the vessel (> 50% obstruction)
• Seizure
• Severe unilateral headache
• Stent migration
• Stent thrombosis
• Stroke
• Transient ischemic attack
• Vasospasm
• Venous occlusion/thrombosis, at puncture site
• Venous occlusion/thrombosis, remote from puncture site
• Vessel rupture, dissection, perforation
X. Device Related Adverse Event Reporting
Any adverse event (clinical incident) involving the Cordis PRECISE PRO RX Nitinol
Stent System should be reported to Cordis immediately. To report an incident, email:
CordisComplaints@cordis.com.
For a patient/user/third party in the European Union and in countries with identical regulatory
regime (Regulation 2017/745/EU on Medical Devices); if, during the use of this device or as a
result of its use, a serious incident has occurred, please report it to the manufacturer as stated
above and/or its authorised representative and to your national authority.
XI. Clinical Benefits
• Improved carotid artery luminal diameter in patients with carotid artery stenosis leading
to improved blood flow to the brain resulting in a reduction in cerebrovascular accidents
(stroke/ transient ischemic attack).
• Lower rates of reintervention in patients with carotid artery stenosis.
XII. SSCP Information
The Summary of Safety and Clinical Performance (SSCP) is available in the European
database on medical devices (EUDAMED), where it is linked to the Basic UDI-DI
(07050320000000000000028CP). The URL to the EUDAMED public website is
https://ec.europa.eu/tools/eudamed.
XIII. SAPPHIRE Study Design
The pivotal SAPPHIRE study was a multi-center, prospective, randomized, The pivotal
SAPPHIRE study was a multi-center, prospective, randomized, triangular sequential trial
comparing patients at increased risk for adverse events from CEA who received a stent to a
surgical (CEA) control. Safety and effectiveness of the Cordis PRECISE Nitinol Stent System,
used in conjunction with the ANGIOGUARD XP Emboli Capture Guidewire in the treatment
of de novo or restenotic obstructive carotid artery disease in these patients were evaluated.
SAPPHIRE also included a non-randomized stent arm for patients who met entry criteria but
were determined by the surgeon to be at too high a risk for adverse outcomes from surgery and
therefore inappropriate for randomization. Likewise, patients meeting the entry criteria, but
determined by the interventionalist to be unacceptable candidates for stenting and therefore
not randomizable, had the option of entering a non-randomized surgical arm. See Table 1
"Acute Procedural Success - All SAPPHIRE Stent Patients" and "See table 2 for Primary Endpoints
– All SAPPHIRE patients".
Table 1: Acute Procedural Success – All SAPPHIRE Stent Patients
Efficacy Measures
Lesion Success 1
Procedure Success 2
Device Success 3
ANGIOGUARD Success
4
1. Lesion Success= The attainment of a final stenosis of <30% using any percutaneous
method. If no in-stent measurements were available, in-lesion measurements were used,
and if no QCA was available, visual estimates were used.
2. Procedure Success= The attainment of a final residual stenosis of <30% an no in-hospital
MAE. If no in-stent measurements were available, in-lesion measurements were used, and
if no QCA was available, visual estimates were used.
3. Device Success= The attainment of a final residual stenosis of <30% using only the
assigned device. If no in-stent measurements were available, inlesion measurements
wereused, and if no QCA was avalable, visual estimates were used.
4. ANGIOGUARD Success= Successful deployment and retrieval of the ANGIOGUARD device.
Table 2: Primary Endpoint - All SAPPHIRE Patients
Safety
Endpoint Measures
Composite of major adverse events
(MAE) including death any stroke,
and/or myocardial infarction at
30-days postprocedure
Composite of major adverse events
at 30-days post-procedure plus
death and/or ipsilateral stroke
between 31-days and 12-months
post-procedure
1. Due to the small number of patients enrolled in the non-randomized Carotid Endarterectomy
(CEA) arm (N=7), those patients are not included in this summary.
8
Randomized Stent Non-Randomized Stent
(N=167) (N=406)
91.8% (145/158) 90.4% (368/407)
88.1% (140/159) 87.9% (355/404)
91.2% (145/159) 89.6% (363/405)
95.6% (152/159) 91.6% (372/406)
Randomized Randomized CEA 1 Non-Randomized
Stent (N=167) (N=167) Stent (N=406)
4.8% (8/167) 9.6% (16/167) 6.9% (28/406)
12% 19.2% 15.8%
(20/167) (32/167) (64/406)
XIV. Directions for Use
Pre- Procedure
The patient should be started on nonbuffered, nonenteric-coated aspirin 72 hours prior to the
procedure per standard hospital dosing guidelines or as prescribed by a physician. Antiplatelet
therapy should be administered 24-48 hours prior to the procedure, according to hospital
protocol. Antiplatelet therapy following a carotid stenting procedure should be administered
per physician instructions.
The percutaneous placement of the stent in a stenotic carotid artery should be done in an
angiography procedure room. Angiography should be performed to map out the extent of
the lesion(s) and the collateral flow. Access vessels must be sufficiently patent or sufficiently
recanalized, to proceed with further intervention. Patient preparation and sterile precautions
should be the same as for any angioplasty procedure.
1. Inject Contrast Media
Perform a percutaneous angiogram using standard technique.
2. Identify and mark the lesion
Fluoroscopically identify and mark the lesion, observing the most distal level of the
stenosis.
Device Selection and Preparation
1. Select Stent Size
Measure the length of the target lesion to determine the length of stent(s) required.
Measure the diameter of the reference vessel (proximal and distal to the lesion). It is
necessary to select a stent which has an unconstrained diameter that is at least 1-2 mm
larger than the largest reference vessel diameter to achieve secure placement according
to the following Table 3: Stent Size Selection.
Table 3: Stent Size Selection
Unconstrained
Vessel Lumen Diameter
Stent Diameter
3.0–4.0 mm
4.0–5.0 mm
5.0–6.0 mm
6.0–7.0 mm
7.0–8.0 mm
8.0–9.0 mm
Refer to product labeling for stent length.
Note: The percent foreshortening of stent length is based upon a mathematical
calculation.
2. Preparation of Stent Delivery System
CAUTION: The stent delivery system is shipped with the Tuohy Borst valve OPEN. Be
careful not to prematurely deploy the stent during preparation. Prep the device in the
tray per instructions below. Close the Tuohy Borst valve prior to removing the device
from the tray.
a. Open the outer box to reveal the pouch containing the stent and delivery system.
b. Check the temperature exposure indicator on the pouch to confirm that the black dotted
pattern with a grey background is clearly visible. See Warnings section.
c. After careful inspection of the pouch looking for damage to the sterile barrier, carefully
peel open the pouch and remove the tray. If it is suspected that the sterility or
performance of the device has been compromised, the device should not be used.
d. While in the tray, attach a stopcock to the Y connection on the Tuohy Borst valve.
e. Attach a 5-cc syringe filled with heparinized saline to the open stopcock and apply
positive pressure until saline weeps from the proximal end of the Tuohy Borst valve. Lock
the Tuohy Borst valve.
f. Close the stopcock attached to the Tuohy Borst Y connection.
g. Extract the stent delivery system from the tray. Examine the device for any damage.
Evaluate the distal end of the catheter to ensure that the stent is contained within the
outer sheath. Do not use if the stent is partially deployed. If a gap between the catheter
tip and outer sheath tip exists, open the Tuohy Borst valve and gently pull the inner
shaft in a proximal direction until the gap is closed. Lock the Tuohy Borst valve after the
adjustment by rotating the proximal valve end in a clockwise direction.
Stent Deployment Procedure
1. Insertion of Introducer Sheath or Guiding Catheter and Cordis ANGIOGUARD RX Emboli
Capture Guidewire System.
a. Access the treatment site utilizing the appropriately sized accessory equipment. See
Table 4: "Recommended Accessory Catheter Sizing."
Table 4: Recommended Accessory Catheter Sizing
PRECISE PRO RX Minimum Sheath
Introducer
Stent Diameter
5, 6, 7, 8 mm 5F (1.98 mm)
9 & 10 mm 6F (2.21 mm)
Insert an appropriately sized Cordis ANGIOGUARD RX Emboli Capture Guidewire System
b.
via the introducer sheath or guiding catheter.
NOTE: PLEASE REFER TO THE CORDIS ANGIOGUARD RX INSTRUCTIONS FOR USE FOR
PLACEMENT PROCEDURE AND USE OF THE DEVICE.
The Cordis PRECISE PRO RX Nitinol Stent System is compatible with a .014" (0.36 mm)
c.
or smaller guidewire.
2. Dilation of Lesion
a. If appropriate, pre-dilate the lesion using standard PTA techniques.
b. Remove the PTA balloon catheter from the patient maintaining lesion access with
the guidewire.
11060616 | Rev:13
Released: 26 Jan 2022
CO: 100553075
Release Level: 4. Production
% Length
Foreshortening
5.0 mm 1.2%
6.0 mm 2.4%
7.0 mm 4.1%
8.0 mm 6.2%
9.0 mm 5.8%
10.0 mm 8.0%
Minimum Guiding
Catheter I.D.
.078" (1.98 mm)
.087" (2.21 mm)