Warning; Device Description; Contents; Intended Use/Indications For Use - Boston Scientific EMERGE MONORAIL Mode D'emploi

Emerge
™
m O n O r a i l ™
O v e r - t h e - w i r e
PTCA Dilatation Catheter
ONLY
caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.

warnInG

Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier
is damaged. If damage is found, call your Boston Scientific representative.
For single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or
resterilization may compromise the structural integrity of the device and/or lead to device
failure, which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or
resterilization may also create a risk of contamination of the device and/or cause patient
infection or cross-infection, including, but not limited to, the transmission of infectious
disease(s) from one patient to another. Contamination of the device may lead to injury, illness
or death of the patient.
After use, dispose of product and packaging in accordance with hospital, administrative and/
or local government policy.

DevIce DescrIptIon

Boston Scientific Emerge Over-The-Wire PTCA Dilatation Catheter and Emerge Monorail
PTCA Dilatation Catheter. The generic name of the device is Over-The-Wire Percutaneous
Transluminal Coronary Angioplasty Dilatation Catheter/Rapid Exchange Percutaneous
Transluminal Coronary Angioplasty Dilatation Catheter.
The Emerge Over-The-Wire (OTW) and Emerge Monorail (MR) Percutaneous Transluminal
Coronary Angioplasty (PTCA) Dilatation Catheters, from Boston Scientific, are Over-The-Wire
and rapid exchange catheters, respectively, with a semi-compliant balloon near the distal
tip. The distal section of both catheters (and the proximal section of the OTW catheter) is
dual lumen and coaxial. The outer lumen is used for inflation of the balloon, and the inner
lumen permits the use of guidewires ≤0.014 in (0.36 mm) to facilitate advancement of the
catheter to and through the stenosis or stent to be dilated. The proximal section of the rapid
exchange catheter is a single-lumen, stainless steel hypotube with a single luer port hub for
inflation/deflation of the balloon. The OTW catheter has a dual luer port hub: one for inflation/
deflation of the balloon, the other for guidewire lumen access. The balloon is designed to
provide an inflatable segment of known diameter and length at recommended pressures. A
balloon protector is placed over the balloon to maintain a low profile and a mandrel is placed
into the inner lumen to protect the patency of the catheter. The catheter's tip is tapered to
facilitate advancement of the catheter to and through the stenosis or stent. In addition to the
standard design, the 1.20 mm and 1.50 mm catheters are offered in "Push" models that provide
different performance characteristics. All shafts have ZGlide™ (hydrophilic) coating. For MR,
the ZGlide is located from the guidewire port to just proximal of the proximal balloon waist. For
OTW, the ZGlide is located from distal of the proximal marks to just proximal of the proximal
balloon waist. All balloons have Xtra™ (hydrophobic) coating and some balloons have ZGlide
applied from the distal tip to just proximal of the balloon, per Table 1.
table 1. emerge balloon coatings
8 mm
1.20 mm
1.20 mm Push
1.50 mm
1.50 mm Push
2.00 mm
2.25 mm
2.50 mm
2.75 mm
3.00 mm
3.25 mm
3.50 mm
3.75 mm
4.00 mm
The effective length of the OTW is 143 cm and the rapid exchange catheter is 144 cm. Marks
on the proximal portion of the catheter shaft indicate the exit of the balloon catheter tip out of
the guide catheter (one at 90 cm and two at 100 cm).
Radiopaque marker bands, in conjunction with fluoroscopy, aid in the placement of the
catheter's balloon segment. The 1.20 mm and 1.50 mm models have one radiopaque marker
band, while all other models have two radiopaque marker bands. A CLIPIT™ Hypotube Clip is
provided with the Emerge Monorail PTCA Catheter to aid in handling of the catheter.

contents

Quantity Material
1 Emerge (Monorail or Over-The-Wire) PTCA Dilatation Catheter
1 CLIPIT Hypotube Clip (Monorail Catheter only)

IntenDeD Use/InDIcatIons For Use

The Emerge Over-The-Wire and Emerge Monorail PTCA Dilation Catheters (balloon models
1.20-4.00 mm) are indicated for the balloon catheter dilatation of the stenotic portion of a
coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
Emerge Over-The-Wire and Emerge Monorail PTCA Dilatation Catheters (balloon models 2.00-
4.00 mm) are also indicated for the post-delivery expansion of balloon expandable stents (bare
metal and drug-eluting).
note: Bench testing was conducted with Emerge Over-The-Wire and Emerge Monorail
PTCA Dilatation Catheters and marketed Boston Scientific balloon expandable stents.
Consideration should be taken when this device is used with different manufacturers' stents
due to differences in stent design. All stents should be deployed in accordance with the
manufacturer's indications and instructions for use.

contraInDIcatIons

• Unprotected left main coronary artery.
• Coronary artery spasm in the absence of a significant stenosis.
3
balloon Length
12 mm 15 mm 20 mm 30 mm
ZGlide
Xtra
and Xtra
Only
Black (K) ∆E ≤5.0