Impella

The Impella is an FDA cleared, percutaneous ventricular assist device designed to provide a patient’s heart with hemodynamics support.

The catheter-based heart pump is manufactured by Abiomed, headquartered in Danvers, Massachusetts. The Impella 2.5 received FDA 510(k) clearance in June 2008.) [1]

The Impella is currently the world's smallest heart pump. The whole device is less than the width of a pencil, and the pump is tinier than an eraser.[2] This tiny device acts like a temporary artificial heart as it maintains blood flow through the body during a cardiac procedure. It works by pumping blood throughout the body when the heart is too weak to do it itself – providing time for the heart to rest and heal.[3]

Doctors insert the Impella, a minimally invasive mechanical circulatory support (MCS) device, into the heart percutaneously, through a small hole in the leg, to provide hemodynamic support for patients. The procedure is typically performed in a catheterization lab (cath lab). This is different than traditional heart therapies which require doctors to open the chest. [4]

A recent study by Yale University published in the Journal of the American College of Cardiology, entitled “National Trends in the Utilization of Short-term Mechanical Support,” found a significant increase – more than 1,500 percent – in the use of minimally invasive percutaneous MCS devices – between 2007 and 2011.[5] As of 2014, 910 hospitals in the United States have acquired Impella products, with over 2,000 implanting physicians.[6]

Impella is now included in five sets of clinical practice guidelines:

1) 2011 American College of Cardiology Foundation (ACCF)/American Heart Association (AHA)/Society for Coronary Angiography Interventions (SCAI) guidelines for Percutaneous Coronary Intervention, JACC 2011;

2) 2013 ACCF/AHA Guidelines for the Management of ST-Elevation Myocardial Infarction, Circulation 2012;

3) 2013 ACCF/AHA guidelines for the Management of Heart Failure, Journal of American College of Cardiology 2013;

4) 2012 AHA guidelines for mechanical circulatory support, Circulation 2012; and

5) 2013 International Society for Heart & Lung Transplantation (ISHLT) guidelines for Mechanical Circulatory Support, The Journal of Heart and Lung Transplantation 2013. [7]

In the U.S., the Impella 2.5, Impella CP and Impella 5.0 pumps have FDA 510(k) clearance for partial to full circulatory support for up to six hours. With over 250 publications, Impella 2.5 is the most extensively used and studied percutaneous circulatory support device available today. A self-contained motor drives the "Impeller" at 50,000 revolutions per minute and drives forward blood flow to support the heart and the rest of the body. [8]

The Impella CP is a more powerful version of its Impella 2.5 pump, delivering up to 3.5 liters of blood per minute percutaneously. The Impella CP device received FDA 510(k) clearance in September 2010.

The Impella 5.0 can be inserted into the left ventricle by femoral cut down or through the axillary artery and provides up to five liters of flow per minute. The Impella 5.0 received FDA 510(k) clearance in April 2009.[9]

See also

References

  1. ↑ "Abiomed Receives 510(k) Clearance from FDA for Impella 2.5". Diagnostic and Interventional Cardiology. June 2, 2008.
  2. ↑ "World's smallest heart pump reaches thousands of patients across US". WCVB Boston. September 6, 2013.
  3. ↑ "World's smallest heart pump reaches thousands of patients across US". WCVB Boston. September 6, 2013.
  4. ↑ "World's smallest heart pump reaches thousands of patients across US". WCVB Boston. September 6, 2013.
  5. ↑ "National trends in the Utilization of Short-Term Mechanical Circulatory Support". Journal of the American College of Cardiology. October 2014.
  6. ↑ "Products". Abiomed. Retrieved 2015-01-13.
  7. ↑ "Products". Abiomed. Retrieved 2015-01-13.
  8. ↑ "Products". Abiomed. Retrieved 2015-01-13.
  9. ↑ "Products". Abiomed. Retrieved 2015-01-13.
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