Deans' stroke musings: AtriCure eyes new stroke market for AtriClip heart device

Changing stroke rehab and research worldwide now.Time is Brain! trillions and trillions of neurons that DIE each day because there are NO effective hyperacute therapies besides tPA(only 12% effective). I have 523 posts on hyperacute therapy, enough for researchers to spend decades proving them out. These are my personal ideas and blog on stroke rehabilitation and stroke research. Do not attempt any of these without checking with your medical provider. Unless you join me in agitating, when you need these therapies they won't be there.

What this blog is for:

My blog is not to help survivors recover, it is to have the 10 million yearly stroke survivors light fires underneath their doctors, stroke hospitals and stroke researchers to get stroke solved. 100% recovery. The stroke medical world is completely failing at that goal, they don't even have it as a goal. Shortly after getting out of the hospital and getting NO information on the process or protocols of stroke rehabilitation and recovery I started searching on the internet and found that no other survivor received useful information. This is an attempt to cover all stroke rehabilitation information that should be readily available to survivors so they can talk with informed knowledge to their medical staff. It lays out what needs to be done to get stroke survivors closer to 100% recovery. It's quite disgusting that this information is not available from every stroke association and doctors group.

Wednesday, December 7, 2011

AtriCure eyes new stroke market for AtriClip heart device

For possible future use.
http://www.medcitynews.com/2011/12/atricure-eyes-new-stroke-market-for-atriclip-heart-device/

Medical device maker AtriCure (NASDAQ:ATRC) is looking to obtain regulatory clearance to use its AtriClip heart device on stroke patients.

The Cincinnati-area company is planning next year to begin a clinical trial that will investigate the AtriClip for use in stand-alone procedures that involve exclusion of the left atrial appendage, a thumb-sized pouch on top of the left side of the heart from which blood clots that cause strokes often originate.

Using the clip device to exclude the pouch could reduce the risk of stroke-causing blood clots in patients who can’t tolerate anti-coagulation drugs, said AtriCure CFO Julie Piton.

But don’t expect the company to obtain clearance for the stroke indication any time soon: Piton said the clinical process to get the label will likely take several years.

Currently, the AtriClip device is cleared in the U.S. only for use in conjunction with other open-cardiac surgical procedures in which the physician has direct visualization. If the company obtains the new clearance it seeks, the device could be marketed for stand-alone thoracoscopic procedures, which involve inserting a a narrow tube with a camera through a small incision in the chest wall.

Obtaining the new clearance would widen the potential market for the AtriClip and facilitate long-term commercialization of the device, CEO David Drachman said during the company’s most recent quarterly earnings conference call with analysts.

Along with the push for a new marketing clearance of the AtriClip, the company is developing a new version of the device’s deployment system, though that doesn’t involve any changes to the clip device itself, Piton said. The changes would make the device easier for surgeons to use in thoracoscopic procedures, she said.

The AtriClip obtained initial U.S. Food and Drug Administration clearance to begin marketing the AtriClip in June 2010.