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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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Trade NameRiver Stent System™
Classification Nameintracranial neurovascular stent
Generic Nameintracranial neurovascular stent
Applicant
Serenity Medical, Inc.
6 cayuga trl.
harrison, NY 10528
HDE NumberH230002
Date Received05/30/2023
Decision Date03/30/2026
Product Code
NJE[ Registered Establishments with NJE ]
Advisory Committee Neurology
Clinical Trials NCT03556085
Supplement Typehde original
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
The river stent system™ is indicated for stenting of the venous sinus in adult patients (22 years of age or older) with idiopathic intracranial hypertension (iih) who have failed medical therapy, have a significant stenosis of the venous sinus (> 50% stenosis and pressure gradient >= 8 mmhg), and have an upstream venous sinus diameter between 5 mm and 8. 5 mm. Patients must also meet one or both of the following criteria:• intractable headache (severe impact with score > 59 on the headache impact test (hit)- 6 scale) and papilledema or a history of papilledema and medical therapy failure for iih for at least 6 months. Patients who are obese [body mass index (bmi) >= 30] must also have completed a weight management program including behavioral therapy, nutritional counseling, and/or medication support for at least 6 months, without achieving adequate relief of their iih symptoms. • moderate to severe papilledema (frisen grade >= 2), transient visual obscuration or 6th nerve palsy who have failed medical therapy and in the opinion of the treating ophthalmologist are losing vision or at risk of losing vision.
Approval OrderApproval Order
SummarySummary of Safety And Probable Benefit
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
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