Safety and Feasibility of the Injectable BL-1040 Implant

• Signed informed consent
• 18 to 75 years of age, inclusive
• Male or female
• Negative pregnancy test for women of child-bearing potential, or surgically sterile, or post menopausal

• Acute MI defined as:

  • Typical rise and gradual fall (troponin) or more rapid rise and fall (CK-MB) of biochemical markers of myocardial necrosis with at least one of the following:

    • Ischemic symptoms;
    • Development of pathologic Qwaves on the ECG;
    • ECG changes indicative of ischemia (ST segment elevation or depression)
    • First anterior or inferolateral STEMI or Qwave MI (QMI Anterior: V1-V3 or V1-V4 or V1-V5 or V1-V6.QMI Inferior: L2, L3, AVF, or L2, L3, AVF+ V5, V6 or L2, L3, AVF+ V6-V9 [posterior leads])
    • Regional wall motion score index (at least 4 out of 16 akinetic segments)

• One or more of the following:

  • LVEF >20% and \<45% measured and calculated by 2-dimensional measurement
  • Biomarkers: peak CK > 2000 IU
  • Infarct size > 25% as measured by MRI
  • Successful revascularization with PCI with 1 stent only, within 7 days of the index MI
  • At time of application of study device, patient must have patent infarct related artery (IRA) and TIMI flow grade = 3

Exclusion Criteria:

• History of CHF, Class I to Class IV, as per NYHA criteria
• History of prior LV dysfunction
• At time of application of study device - Killip III-IV (pulmonary edema, cardiogenic shock - hypotension systolic \< 90 mmHg and evidence of peripheral hypoperfusion oliguria, cyanosis, sweating) or HR > 100 bpm
• Prior CABG
• Prior MI
• History of stroke
• Significant valvular disease (moderate or severe)
• Patient is a candidate for CABG or PCI on non-IRA
• Patient is being considered for CRT within the next 30 days
• Renal insufficiency (eGFR \< 60)
• Chronic liver disease (> 3 times upper limit of normal)
• Life expectancy \< 12 months
• Current participant in another clinical trial, or participation in another trial within the last 6 months
• Any contraindication to coronary angiography, MRI or PCI procedures
• Patient taking anti-coagulation medication prior to MI
• Pregnant or lactating women; pregnancy confirmed by urine pregnancy test