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.

Thursday, October 17, 2024

FDA grants premarket approval to carotid stenting system for stroke

 

 Why are you stenting at all? Verify that the Circle of Willis is complete, close up the offending artery and you won't have to deal with all these complications!

My right carotid artery was closed for 10 years and I cognitively functioned quite well with no episodes of fainting.

Ask your competent? doctor if this guarantees NO complications from stenting!

The latest here:

FDA grants premarket approval to carotid stenting system for stroke

The FDA has granted premarket approval to the Neuroguard IEP System, a novel stenting system intended to ease the process for individuals with stroke, according to the manufacturer.

Contego Medical said in a press release that the system, which is comprised of a high-performance stent, integrated dilation balloon and integrated filters, aims to reduce the steps necessary to place the stent, ensuring greater safety by embolic capture.

FDA HQ in Washington
The FDA granted premarket approval to a novel carotid stent implementation system intended to make the placement process safer and quicker. Image: Adobe Stock

"The idea for the Neuroguard IEP System started with a fundamental question: How can we improve outcomes and reduce procedural complexity for patients undergoing carotid revascularization?,” Contego Medical founder and CEO Ravish Sachar, MD, told Healio in an email.

According to data cited in the release, use of the Neuroguard IEP in the PERFORMANCE I and PERFORMANCE II IDE clinical trials resulted in significantly low event rates related to the carotid arteries; there were no major strokes or neurologic deaths, as well as no record of stent thrombosis at both 30 days and 1 year.

“The key discovery that drove the innovation is that the greatest risk is procedural, particularly during balloon dilation and stenting,” Sachar told Healio. “With the approval, we are ready for more physicians to have access to this standard of care-changing technology.”

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