FDA OKs first compact heart-assist device

Apr 21, 2008

The U.S. Food and Drug Administration announced approval of a compact heart-assist device that's the first to be designed for a small-sized adult.

The FDA said the device mechanically supports the weakened heart of a person suffering heart failure who is at risk of dying while awaiting a heart transplant.

Heart-assist devices are surgically implanted mechanical pumps that help the heart move blood to the rest of the body. Previous models were too large to be placed in the upper abdomen of some women and small-sized men, the FDA said.

But the device approved Monday -- the Thoratec HeartMate II Left Ventricular Assist System -- employs a first-of-a- kind design. Instead of the standard pulsatile pump that simulates the action of the heart, the device uses a continuous flow pump that constantly moves blood with a single moving part, a spinning rotor.

The agency said that design allows the device to be slimmed down to a only 3 inches in length and a weight of approximately 1 pound.

The FDA said the product's manufacturer, the Thoratec Corp. of Pleasanton, Calif., is required to conduct a post-approval study to further evaluate the HeartMate II's performance during commercialization.

Copyright 2008 by United Press International

Explore further: Errata frequently seen in medical literature

add to favorites email to friend print save as pdf

Related Stories

Straight to the heart

Aug 18, 2014

A battery-less, wirelessly-powered implantable defibrillator for atrial fibrillation is being developed by an international team of researchers in the UK, Venezuela and the US. With the ability to sense the ...

Bone marrow-on-a-chip unveiled

May 05, 2014

The latest organ-on-a-chip from Harvard's Wyss Institute for Biologically Inspired Engineering reproduces the structure, functions and cellular make-up of bone marrow, a complex tissue that until now could ...

Privacy issues shadow medical apps' claims to improve care

Sep 02, 2013

Smartphones and tablets are go-to gadgets to count calories, document daily jogs, measure heart rates and record sleep patterns. Some applications now even analyze blood sugar levels, track fertility or monitor moods for ...

Smart sock for baby monitoring in funding campaign

Aug 30, 2013

(Phys.org) —Owlet Baby Monitors, a Salt Lake City business, is self-raising funds for its product, Owlet Vitals Monitor, a "smart" sock on the baby that can monitor vital signs and can send the information ...

Recommended for you

Errata frequently seen in medical literature

1 hour ago

(HealthDay)—Errata, including those that may materially change the interpretation of data, are frequent in medical publications, according to a study published in the August issue of The American Journal of ...

Seven US-based researchers share $1.3M eyesight prize

Sep 10, 2014

Seven U.S.-based researchers are sharing a €1 million ($1.3 million) prize from a Portuguese foundation for their work developing treatment for angiogenic diseases of the retina, the leading cause of blindness in the developed ...

User comments : 0