1. Are there sensitivity challenges in using a single lead?
    • Studies have shown that a single lead, placed in the apex of the right ventricle, allows detection of occlusions that occur in all three major coronary arteries
  2. What about false positives due to normal ST variance and axial shifts?
    • The intra-cardiac lead mitigates against axial shifts
    • Measured event ST levels are significantly higher and longer than than normal ST
  3. What is the expected risk of an implantation?
    • The expected risk is similar to that of single-chamber pacemaker
  4. What are the costs and how are they covered?
    • ALERTS study costs (other than insurance-covered visits due to emergency alarms) covered by AngelMed
  5. What are the limitations of the Guardian System?
    • Must be implanted in a left pectoral pocket
    • Contraindicated for exposure to MRI and diathermy
Caution: Investigational Device. Limited by United States law to investigational use.