Cook Micronized Small Intestinal Submucosa (SIS) for Critical Limb Ischemia

Pilot Safety Study of Micronized Small Intestinal Submucosa (SIS) for Critical Limb Ischemia

This study is intended to collect safety and effectiveness data on the Cook Micronized Small Intestinal Submucosa (SIS)

Inclusion Criteria:

• Rutherford stage 4 or 5 or Leriche-Fontaine classification IIIB
• Patient is unable to be treated by endovascular or surgical means

Exclusion Criteria:

• Patient is pregnant or breastfeeding
• Patient has had a previous surgery within 30 days of the study procedure
• Patient has a planned surgical or interventional procedure within 30 days after the study procedure
• Patient has a life expectancy of less than 1 year
• Patient has a known allergy to pigs or pig products, or has a religious or cultural objection to the use of pig tissue.
• Additional restrictions as specified in the protocol