Pilot Safety Study of Injectable SIS for Critical Limb Ischemia

Pilot Safety Study of Injectable Small Intestine Submucosa (SIS) for Critical Limb Ischemia

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

Inclusion Criteria:

• Diagnosis of critical limb ischemia
• Rutherford 4-5 or Leriche-Fontaine IIIB
• Patient unable to be treated by endovascular or surgical means

Exclusion Criteria:

• Patient's age is <21
• Patient is pregnant or breast-feeding (or is planning to become pregnant within the next year)
• Patient has had a previous surgery, within 30 days of the study procedure
• Patient has any planned surgical or interventional procedure within 30 days after the study procedure
• Patient has a life expectancy 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 Clinical Investigation Plan