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THE TAPE

StimCardio raises $30M to run a wrist-worn nerve stimulator alongside AF ablation FDA early alert covers every Medline brand bed after two deaths CereVasc wins an IDE to test its endovascular CSF shunt in early Alzheimer's Boston Scientific puts the August cyberattack at $150M of lost third quarter sales Boston Scientific pushes its $14.5B Penumbra close into early 2027 GT Metabolic raises a Series C from J.P. Morgan for magnetic anastomosis Ottobock leads a $10.5M Series A in prosthetic control startup Blue Arbor Abbott wins the first US approval for a transcatheter paravalvular leak device Pharaoh Neuro takes a Breakthrough designation for filtering blood out of spinal fluid StimCardio raises $30M to run a wrist-worn nerve stimulator alongside AF ablation FDA early alert covers every Medline brand bed after two deaths CereVasc wins an IDE to test its endovascular CSF shunt in early Alzheimer's Boston Scientific puts the August cyberattack at $150M of lost third quarter sales Boston Scientific pushes its $14.5B Penumbra close into early 2027 GT Metabolic raises a Series C from J.P. Morgan for magnetic anastomosis Ottobock leads a $10.5M Series A in prosthetic control startup Blue Arbor Abbott wins the first US approval for a transcatheter paravalvular leak device Pharaoh Neuro takes a Breakthrough designation for filtering blood out of spinal fluid

IDE

CereVasc wins an IDE to test its endovascular CSF shunt in early Alzheimer's

MedDevice Startups Staff · 1 day ago · 2 min read · Via CereVasc release

FDA approved CereVasc's IDE application on October 29 to study the eShunt System in patients with early symptomatic Alzheimer's disease. The eShunt diverts cerebrospinal fluid into the venous system through a percutaneous transvenous-transdural route, so there is no craniotomy and no tunneled catheter.

The study asks whether increasing CSF cycling helps the brain clear neurotoxins tied to the disease. CereVasc gave no patient count, site count or endpoints. The Boston company built eShunt for communicating hydrocephalus and recently finished enrollment in STRIDE, its randomized trial in normal pressure hydrocephalus.

eShunt is investigational, with no clearance or approval anywhere. Moving a hydrocephalus implant into a neurodegenerative indication widens the market considerably, and the STRIDE result still has to land first.

Questions & Answers

What is the CereVasc eShunt System?

The eShunt System is CereVasc's investigational endovascular shunt that diverts cerebrospinal fluid into the venous system. It is implanted through a percutaneous transvenous-transdural approach rather than open surgery, and was developed for communicating hydrocephalus.

What did FDA approve for CereVasc in October 2026?

FDA approved CereVasc's Investigational Device Exemption application on October 29, 2026, to evaluate the eShunt System in patients with early symptomatic Alzheimer's disease.

Is the CereVasc eShunt System cleared for sale?

No. As of October 2026 the eShunt System is investigational and has not been cleared or approved by FDA or any other regulator. CereVasc recently completed enrollment in STRIDE, its randomized trial in normal pressure hydrocephalus.

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