PROMUS Element⢠Plus - Boston Scientific
PROMUS Element⢠Plus - Boston Scientific
PROMUS Element⢠Plus - Boston Scientific
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All efforts should be taken to assure that the stent is not under-dilated. If the deployed stent size is still inadequate with respect to<br />
vessel diameter, or if full contact with the vessel wall is not achieved, a larger balloon may be used to expand the stent. The stent<br />
may be expanded using a low profile and high pressure balloon catheter. If this is required, the stented segment should be recrossed<br />
carefully with a prolapsed guidewire to avoid dislodging the stent. The balloon should be centered within the stent and should not<br />
extend outside of the stented region.<br />
note: in line with Section 6.16, Post-Procedure: Care must be exercised when crossing a newly deployed stent with any wire,<br />
catheter or ancillary device to avoid disrupting the stent placement, apposition, geometry, and/or coating.<br />
14.5 in vitro information<br />
Table 14.5.1. Typical PrOMUS Element <strong>Plus</strong> Stent System Compliance<br />
Pressure Atm<br />
(kPa)<br />
2.25 mm<br />
Stent I.D.<br />
(mm)<br />
2.50 mm<br />
Stent I.D.<br />
(mm)<br />
2.75 mm<br />
Stent I.D.<br />
(mm)<br />
3.00 mm<br />
Stent I.D.<br />
(mm)<br />
3.50 mm<br />
Stent I.D.<br />
(mm)<br />
4.00 mm<br />
Stent I.D.<br />
(mm)<br />
8.0 (814) 2.29 2.50 2.72 3.24 3.72<br />
9.0 (910) 2.13 2.37 2.58 2.81 3.34 3.81<br />
10.0 (1014) 2.19 2.43 2.65 2.88 3.43 3.89<br />
11.0 (1117) Nominal 2.24 2.50 2.72 2.95 3.51 3.96<br />
12.0 (1213) 2.29 2.55 2.78 3.01 3.58 4.02<br />
13.0 (1317) 2.34 2.60 2.84 3.06 3.63 4.08<br />
14.0 (1420) 2.38 2.65 2.89 3.10 3.68 4.13<br />
15.0 (1517) 2.42 2.68 2.93 3.14 3.73 4.17<br />
16.0 (1620) * 2.45 2.72 2.96 3.17 3.77 4.21<br />
17.0 (1724) 2.47 2.75 2.99 3.20 3.81 4.25<br />
18.0 (1827) * 2.50 2.77 3.03 3.24 3.85 4.30<br />
19.0 (1924) 2.52 2.80 3.06 3.28 3.91 4.36<br />
20.0 (2027) 2.55 2.83 3.09 3.32 3.97 4.43<br />
21.0 (2130) 2.57 2.87 3.13<br />
22.0 (2227) 2.60 2.90 3.17<br />
* RATED BURST PRESSURE. DO NOT EXCEED.<br />
Note: The Stent I.D. values listed are actual average stent inner diameters at the specific balloon inflation pressures obtained<br />
during in vitro testing at 37°C. Balloon pressure must not exceed rated burst pressure of 18 atm (1827 kPa) for the 2.25 mm – 2.75<br />
mm diameter stents and 16 atm (1620 kPa) for the 3.00 mm - 4.00 mm diameter stent sizes.<br />
15 warranTY STaTEMEnT<br />
<strong>Boston</strong> <strong>Scientific</strong> Corporation (BSC) warrants that reasonable<br />
care has been used in the design and manufacture of this<br />
instrument. This warranty is in lieu of and excludes all other<br />
warranties not expressly set forth herein, whether express<br />
or implied by operation of law or otherwise, including, but<br />
not limited to, any implied warranties of merchantability<br />
or fitness for a particular purpose. Handling, storage,<br />
cleaning and sterilization of this instrument as well as other<br />
factors relating to the patient, diagnosis, treatment, surgical<br />
procedures and other matters beyond BSC’s control directly<br />
affect the instrument and the results obtained from its use.<br />
BSC’s obligation under this warranty is limited to the repair<br />
or replacement of this instrument and BSC shall not be liable<br />
for any incidental or consequential loss, damage or expense<br />
directly or indirectly arising from the use of this instrument.<br />
BSC neither assumes, nor authorizes any other person to<br />
assume for it, any other or additional liability or responsibility in<br />
connection with this instrument. bSC assumes no liability with<br />
respect to instruments reused, reprocessed or resterilized and<br />
makes no warranties, express or implied, including but not<br />
limited to merchantability or fitness for a particular purpose,<br />
with respect to such instruments.<br />
Magnetom Trio and syngo are trademarks of Siemens<br />
Aktiengesellschaft Corp.<br />
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Viagra is a trademark of Pfizer Inc.<br />
Zortress, Certican and Afinitor are trademarks of Novartis AG.<br />
20<br />
EC REP<br />
EU Authorized<br />
Representative<br />
<strong>Boston</strong> <strong>Scientific</strong> International S.A.<br />
55 avenue des Champs Pierreux<br />
TSA 51101<br />
92729 NANTERRE CEDEX<br />
FRANCE<br />
Australian<br />
AUS<br />
Sponsor Address<br />
<strong>Boston</strong> <strong>Scientific</strong> (Australia) Pty Ltd<br />
PO Box 332<br />
BOTANY<br />
NSW 1455<br />
Australia<br />
Free Phone 1800 676 133<br />
Free Fax 1800 836 666<br />
Legal<br />
Manufacturer<br />
<strong>Boston</strong> <strong>Scientific</strong> Corporation<br />
One <strong>Boston</strong> <strong>Scientific</strong> Place<br />
Natick, MA 01760-1537<br />
USA<br />
USA Customer Service 888-272-1001<br />
Do not use if package<br />
is damaged.<br />
Recyclable<br />
Package<br />
© 2012 <strong>Boston</strong> <strong>Scientific</strong> Corporation or its affiliates.<br />
All rights reserved.<br />
<strong>Boston</strong> <strong>Scientific</strong>, (Master Brand DFU Template 8.2677in x 11.6929in A4, 90105918AL), eDFU, MB, <strong>PROMUS</strong> Element <strong>Plus</strong>, EN, 90519100-01B
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