Edwards Transfemoral Balloon Catheter
Catéter balón transfemoral Edwards
Cateter-balão Transfemoral Edwards
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English
Instructions for Use
1.0 Device Description
The Edwards Transfemoral Balloon Catheter consists of a shaft and balloon with
two radiopaque marker bands that indicate the working length of the balloon .
The proximal end of the device has a "Y-connector" with a balloon inflation port
labeled as "BALLOON" and a guidewire lumen port labeled as "WIRE" .
The inflation parameters are as follows:
Table 1: Inflation Parameters
Balloon
Model
Diameter
9350BC16
16 mm
Edwards Transfemoral Balloon Catheter
Black dots indicate position of radiopaque marker bands .
1 – Balloon Inflation Port
2 – Guidewire Lumen Port
Edwards, Edwards Lifesciences, and the stylized E logo are trademarks of
Edwards Lifesciences Corporation . All other trademarks are the property of
their respective owners .
DIRECTORY
Nominal
Inflation
Volume
10 mL
4 atm (405 kPa)
1
Device compatibility specifications are as follows:
Model
9350BC16
NOTE: For proper volume sizing, the balloon catheter should be used with the
inflation device provided by Edwards Lifesciences .
2.0 Indications
The balloon catheter is indicated for dilation of stenotic native aortic valve
leaflets .
3.0 Contraindications
The device is contraindicated for patients with:
• Evidence of intracardiac mass, thrombus, vegetation, active infection or
endocarditis;
• Inability to tolerate anticoagulation/antiplatelet therapy .
4.0 Warnings
• The device is designed, intended, and distributed for single use only . Do not
resterilize or reuse the device . There are no data to support the sterility,
nonpyrogenicity, and functionality of the device after reprocessing .
Inflation
Pressure
• Observation of the pacing lead throughout the procedure is essential to
avoid the potential risk of pacing lead perforation .
• Use only appropriate balloon inflation medium . Do not use air or gaseous
medium to inflate the balloon .
THV204
• The balloon inflation diameter must not be significantly greater than the
annulus diameter being pre-dilated .
• The device is not intended for post-dilatation of deployed transcatheter
heart valves .
• While exposed within the body, device advancement and retrieval should
2
not be done without the aid of fluoroscopy . Do not advance or retract the
device unless the balloon is fully deflated under vacuum .
• Do not mishandle the balloon catheter or use it if the packaging or any
components are not sterile, have been opened or are damaged (i . e . kinked
or stretched), or the expiration date has elapsed .
5.0 Precautions
• The safety and effectiveness of the balloon catheter has not been
established in patients who have a congenital unicuspid or congenital
bicuspid aortic valve .
1
Table 2: Device Compatibility
Max. Guidewire
Diameter
0 . 0 35" (0 . 8 9 mm)
Min. Sheath
Compatibility
14F (4 . 7 mm)