Deans' stroke musings: AtriCure gets FDA nod for stroke safety and feasibility trial

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.

Friday, March 2, 2012

AtriCure gets FDA nod for stroke safety and feasibility trial

I think this is for afib but they didn't show a device or explain it in laymans terms.
http://www.medcitynews.com/2012/03/atricure-gets-fda-nod-for-stroke-safety-and-feasibility-trial/?utm_source=rss&utm_medium=rss&utm_campaign=atricure-gets-fda-nod-for-stroke-safety-and-feasibility-trial

This might be it.

Cardiology medical device company AtriCure (NASDAQ:ATRC) has received U.S. Food and Drug Administration approval for a stroke safety and feasibility trial of its AtriClip device.

The trial will enroll up to 30 patients at six sites and begin enrollment in the second half of 2012, CEO Dave Drachman said earlier this week in a conference call with analysts.The Cincinnati-area company is hoping to obtain a label from the FDA for the AtriClip to be used in standalone 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.

The feasibility study is part of the beginning of the process, however. AtriCure doesn’t expect to receive the new label for the AtriClip for several years, chief financial officer Julie Piton said in December.

Here’s how Drachman described the push to obtain the label during the call:

The aim of this project is to start the process of demonstrating that the AtriClip system reduces the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation for whom long-term oral coagulation — anticoagulation therapy — is currently indicated.

AtriCure is also working on a new version of the AtriClip device that could be used in standalone thoracoscopic procedures, which involve inserting a a narrow tube with a camera through a small incision in the chest wall. The existing version of the 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.

AtriCure plans later this year to submit a 510(k) application for the new AtriClip platform, Drachman said.