Evaluation of PerformanCe of the Peripheral EOS in the Treatment of Varicocele or Pelvic Congestion SynDromE

Exclusion Criteria

• •1. Subject has an active systemic infection.
• •2. Subject has a known allergy to iodinated contrast for which they cannot be adequately premedicated.
• •3. Subject has history of stroke within the prior 6 months.
• •4. Subject has history of myocardial infarction with the prior 3 months.
• •5. Subject has acute or chronic renal disease (e.g., as measured by a serum creatinine of \>2.5 mg/dL or \>220 umol/L), or on dialysis.
• •6. Subject has a known coagulopathy or has a bleeding diatheses, thrombocytopenia with platelet count less than 100,000/microliter, or INR \>1.5.
• •7. Co-morbid conditions that place the subject at an unacceptable surgical risk (e.g., severe chronic obstructive pulmonary disease, hepatic failure, cardiac disease, autoimmune disorders or conditions of severe immunosuppression).
• •8. Subjects in whom venography or arteriography is contraindicated.
• •9. Subjects with known hypersensitivity or contraindication to nickel or nitinol.
• •10. Subject has a less than one year life expectancy.
• •11. Subject is pregnant or breastfeeding.
• •12. Subject with endometriosis or other ovarian / uterine pathology with adhesions that would interfere with the endpoints of this study.
• •13. Subject with previous pelvic surgical intervention or embolotherapy for varicocele or ovarian varices that would interfere with the endpoints of this study, including but not limited to, recurrent varicocele or ovarian varices.
• •14. Any clinical evidence that the investigator feels would place the subject at increased risk with the deployment of the device.
• •15. Subject has planned concomitant procedure at the time of the embolization (e.g., coil embolization, etc.).
• •16. Subject is participating in another study of a device, medication, biologic, or other agent within 30 days or could, in the opinion of the investigator, impact the results of this study.
• •17. Subject has other medical, social or psychological problems that in the opinion of the investigator would preclude them from receiving this treatment and the procedures and or participating in evaluations pre- and post-treatment.