AngelMed Guardian® System PMA Post Approval Study

Inclusion Criteria:

1. Subject has at least one of the following conditions:

2. Diabetes (Type I or Type II)

3. Compromised renal function (Cr > 1.2 mg/dl or creatinine clearance less than

3. TIMI Risk Score of at least 3

4. Previously diagnosed with a high-risk acute coronary syndrome (e.g.,Unstable Angina, STEMI or NSTEMI) or has undergone or is scheduled forCABG within 6 months of implantation.

5. Has already undergone coronary angiography and revascularization, unlessthe physician determines it is appropriate to implant before or during theplanned procedure.

6. Lives in a geographic area in close proximity (within approximately 60minutes by EMS) to any hospital that can treat AMI.

7. Subjects (men or women) at least 21 years of age. Women of childbearingage must have a negative pregnancy test or confirmation of one of thefollowing:

8. Post-menopause or amenorrhoeic during the past year

9. Surgical sterilization

10. Use of effective contraceptive method

Exclusion Criteria:

1. In the investigator's opinion, subject lacks ability to respond appropriatelyto alarms, e.g., illiteracy, poor memory or cognitive function, dementia orother condition affecting memory function, etc.

2. There is known compromised tissue at the site of lead implantation in the apexof the right ventricle, e.g., prior infarct affecting the RV apex location.

3. A permanent pacemaker or ICD is already in place or the subject is indicatedfor ICD or pacemaker implantation based on the guidelines published by theAmerican College of Cardiology as Class I and IIa recommendations. Class IIbrecommendations are at the investigator's discretion.

4. Subject cannot feel the IMD vibration when placed on top of the skin on theleft pectoral side of the chest.

5. Subject has recurrent or persistent atrial fibrillation. 6. Subject hasrecurrent or persistent non-sinus cardiac rhythm, second or third degreeatrioventricular blocks, QRS duration greater than 120 ms, Benign EarlyRepolarization (BER), Brugada Syndrome (LLB, BBB, RBB) or Rate Induced BBB.

6. Subject has left ventricular hypertrophy evidenced by EKG criteria. 8. Subjecthas any condition preventing the subcutaneous implantation of the Guardian®System in a left pectoral pouch, such as: superior vena cava thrombosis,subcutaneous tissue deemed inappropriate for the procedure or prior centralvenous access via portacath, Hickman, Groshong, or similar placed in a leftpectoral location or left side PICC line.

7. Subject has extremely heavy alcohol consumption (participates in binge drinkingthat leads to alcohol intoxication) or has history of alcohol or illicit drugabuse within past 5 years.

8. There is evidence of unresolved infection (fever > 38o C and/or leukocytosis > 15,000).

9. Subject has history of bleeding disorders or severe coagulopathy (platelets < 100,000 plts/ml; APTT or PT > 1.3 x reference range).

10. Subject has had a hemorrhagic stroke or transient ischemic attack (TIA) in thepast 6 months.

11. Subject has a potentially fatal disease, such as cancer or refractorycongestive heart failure, associated with limitation of life expectancy, whichmay lead to inadequate compliance to the protocol or confusing datainterpretation.

12. Subject has clinical conditions such as heart diseases, difficult-to-controlblood pressure, difficult-to-control insulin-dependent diabetes or seriousprior infections attributed to the diabetes, or others that, at theinvestigator's discretion, could seriously affect the subject's currentclinical condition during study procedures.

13. Subject has previously been implanted with an AngelMed Guardian® System,current participation or previous participation in another drug or device studyin the past 30 days that conflicts with this study as determined by the studysponsor.

14. Subject has experienced gastro-intestinal hemorrhage in the past 6 months. 17.Subject has any situation in which the use of aspirin is contraindicated for atleast 6 months.

15. Subject has epilepsy. 19. Subject has known severe allergies, e.g., peanut, beesting, etc. 20. Subject has a known coronary occlusion that cannot bereperfused e.g. known multiple small vessel disease, saphenous vein graft,prior angiography where doctor could not intervene, or jailed occlusion.