Device Installation; Indications; Contraindications; Potential Adverse Effects - Boston Scientific Vessix Generator Mode D'emploi

DevIce InstallatIon

To mount the Vessix™ Generator to the roll cart, follow the system assembly/mounting instructions included in the
packaged Vessix Generator box. Installation should be performed by a biomedical technician or other mechanically-
trained personnel.

InDIcatIons

The Vessix™ System is intended to be used to treat patients with uncontrolled hypertension.

contraInDIcatIons

Contraindications include those known for conventional percutaneous interventional procedures.
The Vessix System is NOT intended for use in any artery other than the renal artery.
The Vessix Reduce™ Catheter is NOT intended for use in a renal artery that has an implant, nor is it intended to be used in
calcified areas/segments of renal arteries.

potentIal aDverse effects

Using the Vessix System may cause or contribute to these complications:
• Ablation or thermal injury to vessel, adjacent tissue or other structures from energy application
• Allergic reaction (drug, contrast, device or other)
• Arrhythmia
• Arteriovenous (AV) or arterioenteric fistula
• Cardiopulmonary arrest
• Death
• Embolism (air, plaque, thrombus, device or other)
• Hematoma
• Hematuria
• Hemorrhage
• Hypertension
• Hypotension
• Infection and/or Sepsis
• Myocardial infarction (MI)
• Pain
• Pseudoaneurysm
• Renal artery aneurysm
• Renal artery stenosis or acceleration of atherosclerotic disease
• Renal failure or renal insufficiency
• Renal infarction (including due to embolization of plaque or coagulated/charred blood or tissue)
• Transient ischemic attack (TIA) and/or Cerebrovascular accident (CVA)
• Vasospasm
• Vessel trauma (perforation, dissection, or rupture)
• Vessel thrombosis or occlusion

controls anD InDIcators

Buttons

Power
figure 2: Buttons
Black (K) ∆E ≤5.0
Press to turn on RFG. Hold for at least
power Button
three seconds to turn off RFG.
treat Button Press to advance to Treatment Screen
Treat
or proceed from Treatment Summary
Screen.
note: When in the Treatment Screen, press either button to
immediately halt treatment.
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