AngelMed for Early Recognition and Treatment of STEMI

Inclusion Criteria:

• Subject has at least one of the following conditions:

1. Diabetes (Type I or Type II)

2. Compromised renal function (Cr > 1.2 mg/dl or creatinine clearance less than 50)

3. 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 6months of implantation.

• Has already undergone coronary angiography and revascularization, unless the physiciandetermines 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 anyhospital that can treat AMI.

• Subjects (men or women) at least 21 years of age. Women of childbearing age must havea negative pregnancy test or confirmation of one of the following:

1. Post-menopause or amenorrheic during the past year

2. Surgical sterilization

3. Use of effective contraceptive method

Exclusion Criteria:

• In the investigator's opinion, subject lacks ability to respond appropriately toalarms, e.g., illiteracy, poor memory or cognitive function, dementia or othercondition affecting memory function, etc.

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

• A permanent pacemaker or ICD is already in place or the patient is indicated for ICDor pacemaker implantation based on the guidelines published by the American College ofCardiology as Class I and IIa recommendations. Class IIb recommendations are at theinvestigator's discretion.

• Subject cannot feel the IMD vibration when placed on top of the skin on the leftpectoral side of the chest.

• Subject has recurrent or persistent atrial fibrillation.

• Subject has recurrent or persistent non-sinus cardiac rhythm, second or third degreeatrioventricular blocks, QRS duration greater than 120 ms, Benign Early Repolarization (BER), or Brugada Syndrome.

• Subject has left ventricular hypertrophy evidenced by EKG criteria.

• Subject has any condition preventing the subcutaneous implantation of the GuardianSystem in a left pectoral pouch, such as: superior vena cava thrombosis, subcutaneoustissue deemed inappropriate for the procedure or prior central venous access viaportacath, Hickman, Groshong, or similar placed in a left pectoral location or leftside PICC line.

• Subject has extremely heavy alcohol consumption (participates in binge drinking thatleads to alcohol intoxication) or has history of alcohol or illicit drug abuse withinpast 5 years.

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

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

• Subject has had a hemorrhagic stroke or transient ischemic attack (TIA) in the past 6months.

• Subject has other severe diseases, such as cancer or refractory congestive heartfailure, associated with limitation of life expectancy (less than 1 year), which maylead to inadequate compliance to the protocol or confusing data interpretation.

• Subject has clinical conditions such as heart diseases, difficult-to-control bloodpressure, difficult-to-control insulin-dependent diabetes or serious prior infectionsattributed to the diabetes, or others that, at the investigator's discretion, couldseriously affect the subject's current clinical condition during study procedures.

• Subject has previous participation in the DETECT Study, current participation orprevious participation in another drug or device study in the past 30 days thatconflicts with this study as determined by the study sponsor.

• Subject has experienced gastro-intestinal hemorrhage in the past 6 months.

• Subject has any situation in which the use of aspirin is contraindicated for at least 6 months.

• Subject has epilepsy.

• Subject has known severe allergies, e.g., peanut, bee sting, etc.