The study is enrolling ACS and post-CABG (6 month window) and pre-CABG patients.
ALL of the following criteria must be present:

  • Patient has AT LEAST ONE of the following conditions:
    • Diabetes (Type I or Type II)
    • Compromised renal function (Cr > 1.2 mg/dl or creatinine clearance less than 50)
    • TIMI Risk Score ≥ 3
  • Presents (within past 6 months) with a high-risk acute coronary syndrome (e.g., Unstable Angina, STEMI or NSTEMI) or has undergone or is scheduled for CABG within 6 months of implantation.
  • Has already undergone coronary angiography and revascularization, unless the physician determines it is appropriate to implant before or during the planned procedure.
  • Lives in a geographic area in close proximity (within 60 minutes by EMS) to any hospital that can treat AMI.
  • Patients (men or women) at least 21 years of age. Women of childbearing age must have a negative pregnancy test or confirmation of one of the following:
    • Post-menopausal or amenorrheic during the past year
    • Surgically sterilized
    • Using an effective contraceptive method

    Click here to see the exclusion criteria.

Caution: Investigational Device. Limited by United States law to investigational use.