August 17th, 2016

NEW! Clinical Dossier

Cardiogenic Shock therapy with Impella®

An in-depth clinical review of cardiogenic shock case studies, clinical trial data, outcomes, use in various patient populations, and cost-effectiveness.

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Dr. Bilazarian Introduces cardiogenic shock clinical dossier.

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Dr. Bilazarian discusses each section of the cardiogenic shock clinical dossier.

1

Epidemiology

2

Trends and incidence

3

Challenges

4

Hemodynamic Benefits

5

Clinical Evidence

6

Need for Early Identification

7

Best Practices

8

Cost Effectiveness

April 8th, 2016

Abiomed Impella® Therapy Receives FDA Approval
For Cardiogenic Shock After Heart Attack Or Heart Surgery

Entire Family of Impella Left Side Heart Pumps FDA Approved To Enable Heart Recovery

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Heart Recovery in Action

Read a Patient's Story

Dr. William O'Neill Discusses the Clinical Impact of the Impella FDA Approval for Cardiogenic Shock

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Role of Hemodynamic Support with Impella®

* References 6-24 listed below

Reverse the Cardiogenic Shock Spiral with Impella

New U.S. Food and Drug Administration (FDA) Pre-Market Approval (PMA) for Impella 2.5™, Impella CP®, Impella 5.0™ and Impella LD™ heart pumps to provide treatment of ongoing cardiogenic shock. In this setting, the Impella heart pumps stabilize the patient’s hemodynamics, unload the left ventricle, perfuse the end organs and allow for recovery of the native heart.

Impella provides hemodynamic stability and can reverse this cycle by1,2,3,4,5:

  1. Increasing cardiac output
  2. Decreasing left ventricular end diastolic pressure (LVEDP)
  3. Increasing end organ perfusion
  4. Increasing coronary flow

Best Practices in AMI Cardiogenic Shock

Hemodynamic Stabilization with Impella

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Unloads Left Ventricle1, Coronary Perfusion2

End Organ Perfusion3,4

Right Side Support5

Escalation & Ambulation

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INDICATION FOR USE

The Impella 2.5™, Impella CP®, Impella 5.0™ and Impella LD™ catheters, in conjunction with the Automated Impella Controller, are temporary ventricular support devices intended for short term use (≤ 4 days for the Impella 2.5 and Impella CP, and ≤ 6 days for the Impella 5.0 and LD) and indicated for the treatment of ongoing cardiogenic shock that occurs immediately (< 48 hours) following acute myocardial infarction or open heart surgery as a result of isolated left ventricular failure that is not responsive to optimal medical management and conventional treatment measures.* The intent of the Impella system therapy is to reduce ventricular work and to provide the circulatory support necessary to allow heart recovery and early assessment of residual myocardial function.
*Optimal medical management and convention treatment measures include volume loading and use of pressors and inotropes, with or without IABP.

CONTRAINDICATIONS

In connection with the above indications, the Impella devices are contraindicated for use in patients experiencing the following conditions:
Mural thrombus in the left ventricle; Presence of a mechanical aortic valve or heart constrictive device; Aortic valve stenosis/calcification (equivalent to an orifice area of 0.6 cm2 or less); Moderate to severe aortic insufficiency (echocardiographic assessment of aortic insufficiency graded as ≥ +2); Severe peripheral arterial disease that precludes the placement of the Impella System; Significant right heart failure; Combined cardiorespiratory failure; Presence of an Atrial or Ventricular Sepal Defect (including post-infarct VSD); Left ventricular rupture; and Cardiac tamponade.

POTENTIAL ADVERSE EVENTS

Additionally, potential for the following risks has been found to exist with use of the Impella devices in the above indications: Acute renal dysfunction; Aortic insufficiency; Aortic valve injury; Atrial fibrillation; Bleeding; Cardiogenic shock; Cardiac tamponade; Cardiopulmonary resuscitation; Cerebral vascular accident/Stroke; Death; Device malfunction; Failure to achieve angiographic success; Hemolysis; Hepatic failure; Insertion site infection; Limb ischemia; Myocardial infarction; Need for cardiac, thoracic or abdominal operation; Perforation; Renal failure; Repeat revascularization; Respiratory dysfunction; Sepsis; Severe hypotension; Thrombocytopenia; Thrombotic vascular (non-CNS) complication; Transient ischemic attack; Vascular injury; Ventricular arrhythmia, fibrillation or tachycardia.

References:

  1. Seyfarth M, et al. J Am Coll Cardiol. 2008.
  2. Remmelink M, et al. Catheter Cardiovasc Interv. 2007.
  3. Lam K, et al. Clin Res Cardiol. 2009.
  4. Aqel RA, et al. J Nucl Cardiol. 2010.
  5. Anderson MB, et al. The Journal of Heart and Lung Transplantation. 2015.
  6. Fincke J, et al. Am Coll Cardiol. 2004.
  7. den Uil CA, et al. Eur Heart J. 2010.
  8. Mendoza DD, et al. AMJ. 2007.
  9. Torgersen C, et al. Crit Care. 2009.
  10. Torre-Amione G, et al. J Card Fail. 2009.
  11. Suga H. et al. Am J Physiol. 1979.
  12. Suga H, et al. Am J Physiol. 1981.
  13. Burkhoff D. et al. Am J Physiol Heart Circ. 2005.
  14. Burkhoff D. et al. Mechanical Properties Of The Heart And Its Interaction With The Vascular System. (White Paper) 2011
  15. Sauren LDC, et al. Artif Organs. 2007.
  16. Meyns B, et al. J Am Coll Cardiol. 2003.
  17. Remmelink M, et al. Catheter Cardiovasc Interv. 2007.
  18. Aqel RA, et al. J Nucl Cardiol. 2009.
  19. Lam K,. et al. Clin Res Cardiol. 2009.
  20. Reesink KD, et al. Chest. 2004.
  21. Valgimigli M, et al. Catheter Cardiovasc Interv. 2005.
  22. Remmelink M. et al. Catheter Cardiovasc Interv. 2010.
  23. Naidu S. et al. Novel Circulation. 2011.
  24. Weber DM, et al. Cardiac Interventions Today Supplement. Aug/Sep 2009.