Seal-V Safety and Performance Study

Prospective, Single Arm, Open Label, Non-randomized Study to Evaluate The Safety and Performance of The Seal-V System

The purpose of this study is to further assess the safety and performance of Seal-V as an adjunct to standard surgical procedure for achieving hemostasis in patients undergoing peripheral vascular reconstruction surgeries using synthetic grafts.

Inclusion Criteria:

• Male or female of >18 years of age
• Signed Informed Consent
• Patients requiring vascular reconstruction surgeries using synthetic (such as PTFE, Dacron) or autologous (such as native veins) grafts, including the following:
• Peripheral bypass surgeries, such as arterio-arterial bypasses [including: axillo-(bi)femoral, ilio-(bi)femoral, femoro-femoral, ilio-popliteal, femoro-popliteal (including below knee), femoro-tibial vessel bypass]
• Arteriovenous (AV) dialysis access shunt in the upper or lower extremity
• Patients able and willing to complete all follow-up visits

Exclusion Criteria:

• Vascular surgery other than peripheral bypass surgeries and arteriovenous (AV) dialysis access shunt procedures as described above
• Reoperation at the same treatment site
• Known sensitivity to device materials, such as indigo carmine dye or alginate
• Pregnant or lactating women
• Systemic infection
• Participation in another clinical trial or treatment with any investigational agent in past 30 days
• Congenital coagulation disorders (e.g., thrombocytopenia [<100,000 platelet count], thromboasthenia, hemophilia, or von Willebrand disease)
• Severe congenital or acquired immunodeficiency (e.g., HIV infection or long term treatment with immunosuppressive drugs)
• Prior radiation therapy to the operating field

Intraoperative Exclusion Criteria:

• Major intraoperative complications that require resuscitation or deviation from the planned surgical procedure
• Intraoperative change in planned surgical procedure that results in the patient no longer meeting preoperative inclusion and/or exclusion criteria
• Local infection at the operating field