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, January 29, 2025

FDA grants 510(k) clearance to stroke thrombectomy catheter system

 You'll have to ask your competent? doctor how many get 100% recovered and what they are going to do to reduce the hemorrhage risk to zero.

FDA grants 510(k) clearance to stroke thrombectomy catheter system

The FDA has granted 510(k) clearance to a Bay Area commercial stage medical technology company for its novel large-bore catheter stroke thrombectomy system.

In a press release, device manufacturer Imperative Care Inc. said the Zoom System is “the first comprehensive stroke thrombectomy system to include large-bore .088 catheters indicated for both access and aspiration when used with a Zoom Catheter.”Generic FDA News infographic

The FDA granted 510(k) clearance to a large-bore stroke thrombectomy catheter system. Image: Adobe Stock

The FDA’s decision is based on data from the prospective, multicenter Imperative clinical trial, which evaluated the safety and efficacy of the Zoom catheter system in 211 adult patients with acute ischemic stroke who received care across 26 sites in the United States. According to the release, patients were treated with concurrent aspiration thrombectomy using two catheters.

The Zoom system was associated with a median duration of 19 minutes(Is that fast enough for 100% recovery?)  from groin puncture to modified treatment in cerebral infarction score of at least 2B reperfusion, which is the shortest duration among other thrombectomy trials, the release said.

The Zoom system was also associated with a core-lab adjudicated rate of symptomatic intracranial hemorrhage of 0.9% and a rate of independently adjudicated dissection and vessel perforation of 0.5%, both lower than previous clinical trials, according to the company.

“We know that with stroke, time is the most critical factor in driving positive patient outcomes,” Ariel Sutton, executive vice president and general manager of Imperative Care’s Stroke business, said in the release. “The Zoom system is the first purpose-built technology from access to aspiration that maximizes versatility for rapid and effective procedures as validated by the Imperative trial and previous clinical studies of the Zoom Stroke Solution.”

Reference:

The Imperative Trial: Treatment of acute ischemic stroke with the Zoom reperfusion system. https://www.clinicaltrials.gov/study/NCT04129125?term=Imperative%20Care&rank=1. Accessed Jan. 28, 2025.

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