MAQUET CARDIOHELP Bypass Machine Gets Clearance in U.S.

MAQUET received FDA approval for its CARDIOHELP extracorporeal life support system. The company claims this is the world’s smallest and lightest heart-lung machine and can be used in both ground and air ambulances, as well as for cardiopulmonary support during surgery.
From the announcement:

The individual operating modes and disposables of the CARDIOHELP System make it suitable for conditions in which cardiac and/or respiratory support is needed. The CARDIOHELP System offers several applications to support patients who require veno-venous life support or veno-arterial life support; it can also be used during open heart surgery and for extracorporeal carbon dioxide (CO2) removal up to six hours.
Veno-venous life support, or respiratory assistance for lung disorders, is primarily used when the heart is still able to pump blood through the circulatory system without any additional support, as in the case of acute respiratory failure or a massive pulmonary embolism. The blood is removed from the jugular vein or a femoral vein for enrichment with oxygen, after which it is returned to a vein.
Veno-arterial life support is used with patients whose hearts are not adequately supporting their circulation or have stopped, which may occur with a myocardial infarction. It is vital to ensure cardiopulmonary support as early as possible to prevent organ damage. The CARDIOHELP System can help increase survival by enabling revascularization by means of catheterization or cardiac surgery. In the case of a veno-arterial life support, the blood is removed from the right atrium or a femoral vein and is returned to the aorta or a femoral artery after oxygenation; some of the blood therefore bypasses the heart in a parallel circulatory system, thus relieving stress on the heart muscle.
In severe cases of respiratory failure, the CARDIOHELP System can be used to reduce the CO2 level in the blood. High CO2 levels (e.g., acidosis, pulmonary hypertension) in some cases can lead to complications, and some patients need low to normal CO2 levels to protect the brain.
Minimal extracorporeal circulation (MECC) with the CARDIOHELP System makes life support for cardiopulmonary support during open heart surgery less stressful for the patient than with a conventional heart-lung machine.
The CARDIOHELP System may be installed in ambulances or helicopters and can be connected to the on-board power supply. The integrated rechargeable battery also provides a minimum of 90 minutes of operation without an external power supply. The CARDIOHELP System is operated via an easy touch screen with user guidance and a rotary knob to allow medical personnel with minimal life support experience to safely use the unit after suitable training.
The CARDIOHELP System monitors important blood parameters, including venous oxygen saturation, hemoglobin, hematocrit and arterial and venous blood temperature. The complete sensor system, which also includes three pressure sensors, is integrated into the HLS Module Advanced disposable.
The CARDIOHELP System can be configured to capture case data and data recording intervals can be set individually from 3 seconds to 10 minutes.