About Humanitarian Device Protocols

The FDA oversees Humanitarian Device Protocols for medical conditions presenting in fewer than 4000 patients per year. The purpose of the humanitarian device protocols is to have the best course of treatment for neurovascular diseases such as stroke and aneurysm for all affected patients, even in circumstances where the condition requires a different course of action from normal treatments and procedures.

Active Humanitarian Device Protocols

The following table provides information on active humanitarian device protocols; however, the following protocols are open and ongoing and do not actively enroll new patients.

TitleDevice510K/ IDE/ PMA #SponsorHMH IRBDatesStatusRole
Humanitarian Use Device: NeuroformTM Microdetachable Stent. H-11982. The purpose of this protocol is to make the Neuroform Microdelivery Stent available for use in the population of patient’s wide neck, intercranial, saccular aneurysms that are not amenable to treatment with surgical clipping.NeuroformHMH IRB2002 – presentOpenSub Investigator:
Diaz
Humanitarian Use Device Wingspan Stent System with Gateway PTA Balloon Catheter. WingspanHMH IRB2005 – presentOpenSub Investigator:
Diaz
Cordis Enterprise Vascular Reconstruction Device and Delivery System. EnterpriseCordisHMH IRB2007 – presentOpenSub Investigator:
Diaz
HDE H060001, CODMAN ENTERPRISE® Vascular Reconstruction Device and Delivery System. EnterpriseCodmanHMH IRBunknownOpenSub Investigator:
Diaz
LVIS/LVIS Jr. HUD.LVIS/LVIS Jr.MicroVention, IncHMH IRB2014 – presentOpenSub Investigator:
Diaz

Active Clinical
Device Trials

The purpose of clinical device trials is to advance treatment options in the neurovascular field.

Closed Clinical
Device Trials

Our doctors have participated in previous clinical device trials that are now closed, but have provided successful results in advancing treatment of neurovascular diseases such as aneurysms, strokes, and AVMs.