Case Review of the Penumbra and Indigo Systems for Mechanical Thrombectomy in the Periphery

The Prism Trial: A Retrospective Case Review of Technical Success Using the Penumbra and Indigo Systems for Mechanical Thrombectomy in the Periphery

The primary objective of this retrospective case review study is to determine the safety and effectiveness of the Penumbra and Indigo Systems for mechanical thrombectomy in a cohort of patients with confirmed peripheral or visceral arterial occlusion or embolus. This is a retrospective, single arm, multi-center trial. Up to 100 patients at up to 10 centers will be enrolled. Angiographic assessment of vessel patency at immediate post-procedure as measured by TIMI scores and procedural serious adverse events are assessed and recorded.

Inclusion Criteria:

• Evidence of a peripheral or visceral arterial occlusion or embolus (TIMI 0-1) prior to treatment.
• Treatment with components of the Penumbra and/or Indigo System.

Exclusion Criteria:

• Participation in another clinical investigation that may confound the results of the study.