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(Will your doctor guarantee NO complications?NO! Then it's not safe enough!)

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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