Fully implantable heart approved in the U.S.: Knowledge Driven Revolution

The first fully implantable mechanical heart that allows patients to move about freely for up to two hours has been approved in the U.S., although there are questions about its durability, a Canadian cardiac surgeon said Wednesday.

The grapefruit-sized experimental device was implanted in 14 men from 2001 to 2004. Of them, two died from the operation and one-third never regained consciousness. The rest lived for an average of five months.

The U.S. Food and Drug Administration has granted Abiomed Inc. of Danvers, Mass., a humanitarian exemption, allowing the company to sell up to 4,000 of the devices a year.

"I think the importance of this one is that it is untethered, that means for a short period of time, about an hour or so, the patient can move about without being connected to an outside source," said Dr. Arvind Koshal of the Mazankowski Alberta Heart Institute in Edmonton.

Unlike other devices, the battery source for the new artificial heart does not have a cord that penetrates the skin, said Koshal, who was involved in Canada's first artificial heart implant in 1986.

The device can be implanted in patients who are:

* Over the age of 18.
* Near death from failure of the both of heart's pumping chambers.
* Ineligible for a heart transplant.
* Have a life expectancy of one month without the device.

Patients have their diseased heart removed and then the device is implanted to monitor and control the heart rate. The device includes a belt worn around the abdomen with batteries to charge the internal coil. The pack itself is charged by plugging into an outlet for about an hour.

There are safety issues that will need to be dealt with before the device can be used more widely, Koshal cautioned.

"I think the durability becomes an issue," he said. "Also, we still haven't overcome some of the problems of clot formation which can cause strokes in these patients, or the problem of infection."

The device costs about $250,000 US, and insurance coverage is uncertain.

The FDA is requiring Abiomed to study patients who receive the device and the company must make changes if problems crop up, the agency said Tuesday.

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HOME Canadians Should Pay NOT to be Poisoned: NDP V for Vendetta - R for Reality Canadian Bird Flu Pandemic Looming ? Shill of the Week: Stephan Harper Aspartame: The Sweetest Killer Chicken Little Terrorist of the Week: Creating Fake Terrorists Shill of the Week: Paul Martin The Number 1 Reason YOU became a Slave	Fully implantable heart approved in the U.S. CBC News October 04, 2006 The first fully implantable mechanical heart that allows patients to move about freely for up to two hours has been approved in the U.S., although there are questions about its durability, a Canadian cardiac surgeon said Wednesday. The grapefruit-sized experimental device was implanted in 14 men from 2001 to 2004. Of them, two died from the operation and one-third never regained consciousness. The rest lived for an average of five months. The U.S. Food and Drug Administration has granted Abiomed Inc. of Danvers, Mass., a humanitarian exemption, allowing the company to sell up to 4,000 of the devices a year. "I think the importance of this one is that it is untethered, that means for a short period of time, about an hour or so, the patient can move about without being connected to an outside source," said Dr. Arvind Koshal of the Mazankowski Alberta Heart Institute in Edmonton. Unlike other devices, the battery source for the new artificial heart does not have a cord that penetrates the skin, said Koshal, who was involved in Canada's first artificial heart implant in 1986. The device can be implanted in patients who are: * Over the age of 18. * Near death from failure of the both of heart's pumping chambers. * Ineligible for a heart transplant. * Have a life expectancy of one month without the device. Patients have their diseased heart removed and then the device is implanted to monitor and control the heart rate. The device includes a belt worn around the abdomen with batteries to charge the internal coil. The pack itself is charged by plugging into an outlet for about an hour. There are safety issues that will need to be dealt with before the device can be used more widely, Koshal cautioned. "I think the durability becomes an issue," he said. "Also, we still haven't overcome some of the problems of clot formation which can cause strokes in these patients, or the problem of infection." The device costs about $250,000 US, and insurance coverage is uncertain. The FDA is requiring Abiomed to study patients who receive the device and the company must make changes if problems crop up, the agency said Tuesday. Read the full article here Broken Link? If the link to the original article is broken or has been altered you can view the article by clicking here. About KDR \| \| Home \| \| Weekly Features Archive	Weekly Features Archive
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