Boston Scientific Vessix Catheter Mode D'emploi page 5

F. Vessix™ Catheter Activation and RF Treatment
1. Once connection to the generator is confirmed, the Vessix Catheter can be inflated moving in 0.5 atm increments up to a pressure of 3.0 atm.
When proper apposition is confirmed by the generator upon balloon inflation, fluoroscopy should be used to demonstrate that the catheter is at
the optimal position and that blood flow is occluded. Discontinue use of the catheter if excessive pressure is required to inflate the balloon.
2. Perform the denervation treatment. Follow the Vessix™ Generator Operator's Manual regarding the treatment procedure.
3. Upon completion of the treatment, deflate slowly and retract the balloon proximally towards the ostium of the renal artery.
4. If a second (full or partial) treatment in the same artery is possible and desired, use the distal electrode as a marker to place the balloon 5 mm
proximal to the first treatment, so that there is no overlapping of treatment areas. (Note: To allow for a partial treatment it is acceptable for the
balloon to be located partially outside of the renal artery in the aorta). Repeat steps F1 and F2 in order to perform a second treatment in the same
artery.
5. When treatment is complete, deflate slowly and carefully retract the balloon back into the guiding sheath. If resistance is encountered, advance
the balloon 5 to 10 mm back into the renal artery, and carefully retract the balloon again into the sheath.
6. Perform post procedural imaging on each renal artery treated.
7. Treat the contralateral renal artery at this time if the catheter is appropriately-sized. If treatment of the contralateral renal artery requires a
different balloon size, remove the catheter (per section G), and insert an appropriately sized catheter (per sections D through F).
G. Vessix Catheter Deflation and Removal
1. Slowly deflate the balloon by 0.5 atm decrements and finally pull to negative pressure.
2. Carefully retract the catheter through the guiding sheath and out of the body. The guide wire should remain in the renal artery for a post-
procedure selective renal arteriogram. If excessive resistance is met, using fluoroscopy carefully remove the entire system simultaneously
(catheter, guide wire, and guiding sheath).
3. Upon completion, either manual compression or commercialized closure devices can be used to achieve hemostasis at the puncture site.
Standard-of-care post-intervention monitoring procedures should be followed.
WARRANTY
Boston Scientific Corporation (BSC) warrants that reasonable care has been used in the design and manufacture of this instrument. This warranty is
in lieu of and excludes all other warranties not expressly set forth herein, whether express or implied by operation of law or otherwise, including,
but not limited to, any implied warranties of merchantability or fitness for a particular purpose. Handling, storage, cleaning and sterilization of
this instrument as well as other factors relating to the patient, diagnosis, treatment, surgical procedures and other matters beyond BSC's control
directly affect the instrument and the results obtained from its use. BSC's obligation under this warranty is limited to the repair or replacement of
this instrument and BSC shall not be liable for any incidental or consequential loss, damage or expense directly or indirectly arising from the use of
this instrument. BSC neither assumes, nor authorizes any other person to assume for it, any other or additional liability or responsibility in connection
with this instrument. BSC assumes no liability with respect to instruments reused, reprocessed or resterilized and makes no warranties, express or
implied, including but not limited to merchantability or fitness for a particular purpose, with respect to such instruments.
Cook Medical Flexor® Ansel Check-Flo® is a trademark of Cook Medical Incorporated
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