Abbott Approved by FDA to Sell HeartMate 3

August 30, 2017

The Food and Drug Administration has granted Abbott Laboratories approval to sell a left ventricle-assist device (LVAD) which magnetically suspends a propeller that spins continuously at regular intervals, simulating a pulse, to pump blood for heart-failure patients.

Abbott Approved by FDA to Sell HeartMate 3

Doctors typically treat heart failure by using prescription drugs, physical exercise and diet change, but implanted devices may be used on advanced cases that don’t respond to treatment. The HeartMate 3 is one of the most complex treatment options outside of an artificial heart or transplant.

A ventricle assist device takes the blood out of the damaged ventricle, most commonly the left ventricle, and pumps it into the aorta above the heart with enough force to improve full-body circulation. Traditional LVADs, including Abbott’s HeartMate II, have lowered enthusiasm for implanted devices because the propeller is mounted on bearings inside the device to create blood momentum. Friction from the rotors and narrow passages in the device can create blood clots and lead to mechanical damage, referred to as pump thrombosis. This can potentially result in stroke and re-operation to replace the clotted device.

The HeartMate 3 is rated as safer than traditional LVADs because of wider passages and the friction and cellular damage caused by the rotors mounted on bearings is eliminated. Clinical results have shown that no HeartMate 3 patients were diagnosed with pump thrombosis and there was a decrease in stroke among patients and device problems compared to the HeartMate II.

The HeartMate 3 is currently only approved as a “bridge to transplant” therapy meaning it is only intended to keep the patient alive long enough to get a heart transplant. Abbott is performing tests to support long-term use of the HeartMate 3 for patients who don’t expect to get another heart.

AIV, Inc. is committed to providing high quality IV pumps, replacement parts, accessories and repair service for major infusion equipment manufacturers. Learn more about AIV’s wide selection of IV pump solutions at https://aiv-inc.com/infusion-pump-parts.html.

The Food and Drug Administration has granted Abbott Laboratories approval to sell a left ventricle-assist device (LVAD) which magnetically suspends a propeller that spins continuously at regular intervals, simulating a pulse, to pump blood for heart-failure patients.

Doctors typically treat heart failure by using prescription drugs, physical exercise and diet change, but implanted devices may be used on advanced cases that don’t respond to treatment. The HeartMate 3 is one of the most complex treatment options outside of an artificial heart or transplant.

A ventricle assist device takes the blood out of the damaged ventricle, most commonly the left ventricle, and pumps it into the aorta above the heart with enough force to improve full-body circulation. Traditional LVADs, including Abbott’s HeartMate II, have lowered enthusiasm for implanted devices because the propeller is mounted on bearings inside the device to create blood momentum. Friction from the rotors and narrow passages in the device can create blood clots and lead to mechanical damage, referred to as pump thrombosis. This can potentially result in stroke and re-operation to replace the clotted device.

The HeartMate 3 is rated as safer than traditional LVADs because of wider passages and the friction and cellular damage caused by the rotors mounted on bearings is eliminated. Clinical results have shown that no HeartMate 3 patients were diagnosed with pump thrombosis and there was a decrease in stroke among patients and device problems compared to the HeartMate II.

The HeartMate 3 is currently only approved as a “bridge to transplant” therapy meaning it is only intended to keep the patient alive long enough to get a heart transplant. Abbott is performing tests to support long-term use of the HeartMate 3 for patients who don’t expect to get another heart.

AIV, Inc. is committed to providing high quality IV pumps, replacement parts, accessories and repair service for major infusion equipment manufacturers. Learn more about AIV’s wide selection of IV pump solutions at http://aiv-inc.com/iv-pump-parts-service.html.

About the Author

Laura Collier

Laura Collier

Laura Collier has a Bachelor’s Degree in Communications and a Master’s Degree in Business Administration from the University of North Florida. She is the Marketing Manager at AIV, Inc.

AIV Catalog

Request Your Printed or Electronic Copy Today!
We Respect Your Privacy

Be Part of Our
Biomed Community

Healthcare technology management professionals are a vital link in hospital operations, and we proudly support the national, state, and local associations with ongoing support and resources.

Get Biomed Resources

Why buy from AIV

AIV strives to provide you cost effective options to service equipment. We offer flexible solutions to best suit your needs.