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FDA approves Heart Mate II – Blood Pump for the Heart for Patients With Advanced Heart Problems

Posted Jan 27 2010 11:46pm

A new smaller version of the Heart Mate has been approved by the FDA.  I had a related post back in 2008 about how the device from Thoratec was responsible for extending the life of a man who needed both kidney and heart transplants.   If you read through you can see where mechanical improvements were also made with the new model.  The device is for those with extreme and advanced heart problems to pump blood.  It is implanted via a minimally invasive procedure. 

This is a wearable system that comes with a group of accessories such as a carrying bag, batteries, etc.  The controls are on the outside for this device.  BD 

The U.S. Food and Drug Administration approved use of a heart pump on Wednesday that was largely designed and tested at the Texas Heart Institute.image

The HeartMate II device, a continuous-flow pump that aids the heart's left ventricle, can now be used in all patients with advanced heart failure, not just those awaiting a heart transplant, the regulatory agency said.

“This is a big day that we've long awaited,” said Dr. Roberta Bogaev, medical director of Heart Failure and Transplant at the heart institute.

The HeartMate II device is smaller than its predecessor and substantially different in that it produces a continuous flow of blood, rather than the earlier pulsatile pump that mimicked blood flowing from a beating heart. The lightweight pump is implanted just above the patient's heart, and an electric cord passes through the patient's skin to an external battery and controller device.

The continuous flow innovation makes for a smaller pump that allows users to have a more active lifestyle, Bogaev said. The pump also fits into smaller patients.

The FDA approval comes on the heels of a study published last month in the New England Journal of Medicine which found that 58 percent of patients with advanced heart failure who received the HeartMate II device lived for two years or longer, compared with 24 percent with the HeartMate I.

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