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.”
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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