Showing posts with label device. Show all posts
Showing posts with label device. Show all posts

Wednesday, May 16, 2012

In Rat Study, Eye Device Shows Promise for Restoring Sight

HealthDay – 1 hr 38 mins ago SUNDAY, May 13 (HealthDay News) -- A new type of artificial eye system could one day restore sight to people who have lost their vision due to degenerative eye diseases such as macular degeneration, according to the results of research with rats.

The system uses tiny solar panel-like cells that are surgically placed beneath the retina, along with a specially designed pair of goggles equipped with a miniature camera, and a pocket PC that processes the visual data, the Stanford University School of Medicine team explained.

Visual images are displayed on a liquid crystal microdisplay embedded in the goggles, similar to what's used in video goggles for gaming. The images are beamed from the liquid crystal display to the cells implanted in the retina, which then sends the images to the brain.

The research is published online May 13 in the journal Nature Photonics.

"It works like the solar panels on your roof, converting light into electric current. But instead of the current flowing to your refrigerator, it flows into your retina," senior study author Daniel Palanker, an associate professor of ophthalmology, said in a Stanford news release.

The scientists are currently testing the system in rats and are seeking a sponsor to support tests in humans. Research that seems promising in animal studies often fails to offer similar benefits to humans.

The researchers hope their system can eventually help people with retinal degenerative diseases such as age-related macular degeneration and retinitis pigmentosa. Age-related macular degeneration is the leading cause of vision loss in North America and about 1.5 million people worldwide have lost their sight due to retinitis pigmentosa, according to the nonprofit group Foundation Fighting Blindness.

More information

The U.S. National Eye Institute has more about age-related macular degeneration.



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Thursday, April 26, 2012

FDA advisers back HeartWare blood pump device

Reuters – 3 hrs ago WASHINGTON (Reuters) - HeartWare International Inc won a U.S. advisory panel's support on Wednesday for its most important product - a blood pump that helps people with severe heart failure.

A panel of outside experts to the Food and Drug Administration voted 9-2 to recommend approval of the mechanical heart-assist device, called the HeartWare ventricular assist device (HVAD). HeartWare shares were halted pending the panel outcome.

The FDA usually follows panel advice, although it is not required to and a final decision is expected later.

Panelists said the device helped save lives, although they expressed doubts about the company's conduct of clinical trials and about missing safety data.

"Overall, this is a novel device for a desperate population, and I hope it will be available soon," said panel member Dr. David Slotwiner, of the Long Island Jewish Medical Center.

Heart failure is a chronic condition with no cure, in which the heart is too weak to pump enough blood to meet the body's needs. In the most severe cases, people may need a heart transplant.

HeartWare's device helps people with failing hearts pump blood while awaiting a transplant. The device is already approved in Europe.

It is estimated that some 50,000 people around the world are candidates for heart transplant, but only some 5,000 patients per year get them.

But reviewers from the FDA said earlier this week they were concerned about device-related clotting rates and stroke. FDA reviewers and outside experts to the agency also said clinical trial results may have missing data, meaning they could over-estimate how well the device works.

"In terms of safety, these data have more holes in them than Swiss cheese," said panel member Dr. Gregory Dehmer, of Texas A&M University.

Panel members called for HeartWare to conduct further safety trials if the FDA approves its device.

If approved, the device will compete with Thoratec Corp's HeartMate II, which has been sold in the United States since 2008. It is currently the only blood pump available to people with heart failure awaiting a transplant.

Thoratec shares fell 1.5 percent in after-market trading.

Many investors have been betting HeartWare's device will eventually eclipse the HeartMate II since it is smaller and takes less time to implant. However, concerns about pump-associated thrombosis, or the formation of blood clots, as well as stroke issues, could hurt market share.

HeartWare said it changed the instructions for doctors using the device to reduce the risk of clots and there was no evidence strokes in clinical trials were linked to its device.

"Each device is going to have its relative strengths and our patients deserve these options," said Dr. Keith Aaronson, a paid consultant for HeartWare and professor of internal medicine at the University of Michigan. "And as a cardiologist treating patients with advanced heart failure, I feel strongly we need to have competition in this field."

(Editing by Gary Hill, Bernard Orr and Andre Grenon)



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Wednesday, April 18, 2012

Analysis: Heart device troubles cloud St Jude's outlook

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Monday, April 2, 2012

Cheap, safe device helps avoid premature birth

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