Device Description - Boston Scientific Vessix Catheter Mode D'emploi

Vessix
™
Renal Denervation Catheter
ONLY
Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.
This device should only be used by physicians trained in angiography and percutaneous interventional techniques.
CAREFULLY READ ALL INSTRUCTIONS PRIOR TO USE. OBSERVE ALL WARNINGS AND PRECAUTIONS NOTED IN THESE DIRECTIONS AND IN THE
VESSIX™ GENERATOR OPERATOR'S MANUAL. FAILURE TO DO SO MAY RESULT IN SERIOUS COMPLICATIONS.
Refer to the instructions supplied with the interventional devices used in conjunction with the Vessix Catheter. (Figure 1 below)
WARNING
The Vessix Catheter is designed and intended to be used ONLY with the Vessix Generator
• Contents supplied STERILE using a Radiation 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.
• No modification of this equipment is allowed.
• After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy.
• The system must be used under fluoroscopic observation with radiographic equipment that provides high quality images.
• The device must be used by trained physicians skilled in percutaneous, interventional techniques in a fully equipped catheterization laboratory.
• DO NOT retract the Vessix Catheter unless the balloon is fully deflated under vacuum. If significant resistance is met during manipulation, determine
the cause of the resistance before proceeding. If excessive resistance is met during withdrawal of the Vessix Catheter, use fluoroscopy to verify the
resistance, then remove the entire system simultaneously (catheter, guide wire, guiding sheath) using fluoroscopic guidance.
• To avoid the risk of patient injury or catheter failure, do not deliver more than five (5) treatment cycles combined per catheter. If more treatments
are needed, use additional catheters.
• Use only the recommended balloon inflation medium (normal heparinized saline and contrast at ratios recommended in this instruction). Never
use air or any gaseous medium to inflate the balloon.
• Use the catheter prior to the "Use By" (expiration) date specified on the package.
• Balloon pressure should not exceed the maximum inflation pressure of 5.0 atm.

DEVICE DESCRIPTION

The Vessix™ System consists of the Vessix Catheter, a non-compliant balloon catheter with electrical contacts mounted on the exterior of the balloon,
the Vessix Generator, and connecting cables.
The Vessix Catheter is available in balloon diameters of 4.0 mm, 5.0 mm, 6.0 mm and 7.0 mm with a balloon length of 25 mm and treatment length of 21 mm.
The catheter has a total working length of approximately 90 cm. It is recommended that the Vessix Catheter be connected to the Vessix Generator by
means of the non-sterile patient extension cable, which is approximately 3 meters in length. Optionally, the Vessix Catheter may be connected directly to
the Vessix Generator.
The Vessix Catheter is inflated at a very low pressure until electrodes are properly apposed against the renal artery wall. Controlled low-powered
radiofrequency (RF) energy is then delivered briefly to the electrodes by the Vessix Generator. This delivery of energy causes thermal heat to perfuse
through the artery wall into the adventitia layer of the artery and results in denervation of the target renal nerves. During the treatment the RF generator
delivers low average power at each electrode. The RF generator provides visible prompts to guide the operator through setup and treatment steps.
Working Length:
90 cm
Distal Tip and
Guidewire Port
Figure 1
Black (K) ∆E ≤5.0
Catheter
Balloon and
Electrodes
Inflation Port
Proximal
Guidewire
Port
1.4 m
Extension
2
Electrical
Connector