Serenity Medical secures FDA humanitarian exemption for cerebral venous stent

The FDA’s HDI makes Serenity’s River the first stent approved for severe idiopathic intracranial hypertension treatment.

Serenity Medical Receives U.S. FDA HDE Approval of the River(TM) Stent - the First Venous Stent Approved for Severe, Refractory Idiopathic Intracranial Hypertension (IIH)

Landmark regulatory milestone makes the River stent available for adults with severe IIH -- a debilitating, historically undertreated condition -- who have failed medical therapy Serenity Medical ...
Forbes

Taxpayers Spent Over $800 Million For Unnecessary Coronary Stents A Year, Report Finds

A new report published Tuesday found over one in five coronary stents placed between 2019 and 2021 were unnecessary, costing Medicare $800 million a year and putting patients at risk of complications ...
MassDevice

Serenity Medical earns FDA humanitarian approval for cerebral venous stent

Serenity Medical announced today that it received FDA Humanitarian Device Exemption (HDE) approval for its novel River stent.
Endovascular Today

Getinge’s iCast Covered Stent System Receives FDA Approval for New Sizes

Getinge announced it has received FDA premarket approval for additional sizes of its iCast covered stent system. The approval ...

How a life-changing stent could help a Palo Alto investor shake up the medical device industry

Preview this article 1 min A sales confederation could help entrepreneurs hold on to their medical device companies. Thursday ...
The Baltimore Sun

Whether a stent is needed can be tough call

When patients are in the throes of a heart attack, there’s no question that stents save lives. But for heart patients with few symptoms and less than severe artery blockage, whether to use a stent is ...
Endovascular Today

MicroPort NeuroScientific Apollo Dream Sirolimus Target-Eluting Stent Granted FDA Breakthrough Device Designation

MicroPort NeuroScientific Corporation announced that the company’s Apollo Dream sirolimus target-eluting stent system has b ...
TCTMD

Treatment of Osteal Cx Stent Restenosis: Need for well rested operator and a winning strategy

The LMCA was engaged with an EBU 4 6 Fr guiding catheter through right radial approach.10000U of heparin was given. An Asahi soft guidewire was placed in Cx and balloon predilatation was made by 2x15 ...
MassDevice

Starlight Cardiovascular reports first baby treated with Lifeline pediatric stent system

Starlight Cardiovascular announced today that the first baby in the world received treatment with its Lifeline pediatric ...
CBS News

Stent designed for babies and young kids shows preliminary success

Jon LaPook, M.D. is the award-winning chief medical correspondent for CBS News. Since joining CBS News in 2006, LaPook has delivered more than 1,200 reports on a wide variety of breaking news and ...