EMBA Peripheral Embolization Device ("EPED") Study

This study is a FIM, open label, prospective, single center, non-randomized, evaluation of the EMBA Medical Peripheral Embolization Device (PED) used for arterial or venous embolization in the peripheral vasculature.

Inclusion criteria

• The patient is >18 years of age.
• Patient is considered a candidate for arterial or venous embolization in the peripheral vasculature.
• Patient has a target vessel diameter of 3-8mm and a target PED landing zone of greater than 25mm wherein the vessel diameter is between 3 and 8 mm.
• The patient or legal guardian has been informed of the nature of the study and agrees to its provisions and has provided informed written consent.
• The patient has suitable vessel anatomy that would allow proper placement of the PED.

Exclusion criteria

• The patient has one of the following conditions:

1.1 Arterio-venous fistula 1.2 Hypercoagulability 1.3 Systemic coagulopathy 1.4 Connective tissue disorder such as Ehlers-Danlos Syndrome 1.5 Congenital arteritis such as Takayasu's Disease 1.6 Other circulatory disorders at the discretion of the implanting physician

• The patient has an uncontrolled infectious disease.
• The patient has a life expectancy of less than 6 months.
• The patient is pregnant.
• The patient has a condition that inhibits radiographic visualization of the PED.
• The patient has a known allergy or intolerance to Nitinol.
• The patient has a known hypersensitivity to contrast that cannot be pre-treated.
• The patient's access vessels preclude safe insertion of the delivery system.
• The patient is currently participating in another device or drug study.