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Impella® - The System for Biventricular Cardiovascular Support

The Impella® Circulatory Support System is used for temporary, mechanical cardiovascular support for patients whose hearts demonstrate a limited ejection rate. Approximately 0.5 % to 2 % of all patients who undergo heart surgery, as well as 4 % to 6 % of all patients with acute myocardial infarction, require support above and beyond conventional therapy (medication and intra-aortic balloon). In Europe alone, heart surgery was performed in roughly 360,000 cases in the year 2005, and over 1 million patients suffered a myocardial infarction.

 

Development of the Impella® System was based upon Impella's platform technology. An electric motor with a diameter of only 6.4 mm assures pump delivery rates up to 5 liters per minute. Impella® is thus the world's smallest and, above all, the only truly minimally invasive, mechanical cardiovascular support system. The Impella system is so small that it can be inserted into the heart via the groin without opening the thorax and can be removed in the same way.

The micro-axial pumps keep damage to the blood to a minimum, the extent of which is greatly dependent upon the size of synthetic surface areas. The use of hemodilution medications can thus be significantly reduced (heparin). Since a fully implantable system with micro-axial pumps is utilized (i.e. only one cable with a diameter of 3 mm (9 Fr) exits the patient), the danger of infection is also extremely minimal. The system consists of the fully implantable Impella® LD pump, a Mobile Console for controlling the system and the Purger for rinsing the pumps. The system is used in Europe for providing temporary cardiovascular support.

 

Impella® LD for Left Ventricular Support

The Impella® LD is the smallest technology available for left ventricular unloading, weighing only 8 grams.

The Impella® LD is used to provide support for patients suffering from reduced cardiac output. The catheter is inserted directly into the heart via the ascending aorta and is advanced through the aortic valve and into the left ventricle. It can remain implanted supporting the heart for up to 10 days.

 

 

Once positioned, the catheter draws blood from the left ventricle and delivers it into the ascending aorta. The pump is capable of supporting the human heart by delivering a total of up to 5 liters of blood per minute.

The system is generally implanted after the thorax has already been opened for heart surgery.

 

Impella® System Indications

  • Reduced ejection rate from the heart, e.g. after heart surgery (postcardiotomy)
  • Acute myocardial infarction
  • Cardiogenic shock / Low Output Syndrome
  • Coronary bypass surgery on the beating heart, for patients with limited preoperative ejection rate and high risk of postoperative low output syndrome
  • Temporary support until a long-term cardiovascular support system can be implanted (bridge to bridge)
  • Cardiovascular support after heart transplant (post transplant)
  • Pulmonary hypertonia
  • Myocardial inflammation
  • Post coronary intervention
  • Bridge to Recovery
  • Bridge to next decision

Impella® System Advantages

  • Can be used for right ventricular, left ventricular or biventricular cardiovascular support
  • World's smallest cardiovascular support system - fully implantable and minimally invasive
  • Extremely small synthetic surfaces - minimal hemodilution (anticoagulation)
  • Quick and easy to implant
  • Minimal procurement costs
  • Cardiac support can be adjusted according to patient needs
  • High flow rate (up to 5 liters)
  • Increase of cardiac output, coronary and end-organ perfusion
  • Reduction of myocardial workload and oxygen consumption