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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.
| Title | Device | 510K/ IDE/ PMA # | Sponsor | HMH IRB | Dates | Status | Role |
|---|---|---|---|---|---|---|---|
| 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. | Neuroform | HMH IRB | 2002 – present | Open | Sub Investigator: Diaz |
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| Humanitarian Use Device Wingspan Stent System with Gateway PTA Balloon Catheter. | Wingspan | HMH IRB | 2005 – present | Open | Sub Investigator: Diaz |
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| Cordis Enterprise Vascular Reconstruction Device and Delivery System. | Enterprise | Cordis | HMH IRB | 2007 – present | Open | Sub Investigator: Diaz |
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| HDE H060001, CODMAN ENTERPRISE® Vascular Reconstruction Device and Delivery System. | Enterprise | Codman | HMH IRB | unknown | Open | Sub Investigator: Diaz |
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| LVIS/LVIS Jr. HUD. | LVIS/LVIS Jr. | MicroVention, Inc | HMH IRB | 2014 – present | Open | Sub Investigator: Diaz |
The purpose of clinical device trials is to advance treatment options in the neurovascular field.
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.
Our surgeons at Houston Neurovascular Center are premier healthcare providers for Interventional Neuroradiology in Houston. Dr. Orlando Diaz and Dr. Richard Klucznik practice as a part of Houston Radiology Associated in all locations of the Houston Methodist Hospital System.
Houston Radiology Associated at Houston
Methodist Hospital Central
Texas Medical Center
6565 Fannin Street | 2nd Floor | Houston, TX 77030
Please call (713) 441-1085 to book an appointment today.