News | April 15, 2007

ev3's Onyx HD 500 Liquid Embolic System Gets FDA Clearance

April 16, 2007 - ev3 Inc. has received Humanitarian Device Exemption (HDE) clearance from the FDA for its Onyx HD 500 Liquid Embolic System for the treatment of intracranial aneurysms. This approval allows ev3 to commercialize its Onyx Liquid Embolic System to a population of patients with wide-necked cerebral aneurysms. The approval is limited to saccular, sidewall aneurysms with a dome to neck ratio less than 2mm that are not amenable to treatment with surgical clipping. ev3's Onyx 18 and 24 Liquid Embolic System received FDA approval in July of 2005 for the treatment of cerebral arteriovenous malformations.

Jim Corbett, CEO of ev3, commented, "We are delighted with the HDE approval of Onyx HD 500 as it provides physicians a new clinical tool to treat patients with wide-neck cerebral aneurysms who have very few therapeutic options. This approval further documents the unique therapeutic profile of our Onyx technology platform."

Cerebral aneurysms are vascular abnormalities in the brain that are characterized by a bulge in the wall of a blood vessel. These defects can cause severe neurologic symptoms, including death in the case of a rupture. A U.S. Investigational Device Exemption study and two European clinical studies closely examined the treatment of nearly 200 aneurysms, demonstrating that patients with wide-necked aneurysms were effectively treated with the Onyx HD 500 Liquid Embolic System. Wide-necked aneurysms occur in approximately 20 percent of the 17,000 patients that are treated each year in the U.S. with embolic coils.

Onyx HD 500 will be marketed in the U.S. by the ev3 Neurovascular sales force. As the first liquid embolic to be approved for the treatment of cerebral aneurysms, the release of Onyx HD 500 will be preceded by a lengthy period of education and training for a small group of leading neurovascular specialists. Once trained, this group of proctors will help insure that the use of Onyx HD 500 is carefully controlled as is required for all HDE approved devices.

Related Content

Minimally Invasive Treatment Provides Relief from Back Pain

Lumbar spine MRI showing disc herniation and nerve root at baseline and one month after treatment

News | Interventional Radiology | January 11, 2018
The majority of patients were pain free after receiving a new image-guided pulsed radiofrequency treatment for low back...
Guerbet Announces Acquisition of Accurate Medical Therapeutics
News | Interventional Radiology | January 08, 2018
Guerbet announced that it has entered into an agreement under which it will acquire Israeli company Accurate Medical...
ACR Appropriateness Criteria Adds and Revises Topics for December 2017
News | Clinical Decision Support | December 29, 2017
December 29, 2017 — Radiologists can enhance the quality and effectiveness of care with the newest release of the ACR
Videos | RSNA 2017 | December 20, 2017
ITN and DAIC Editor Dave Fornell takes a tour of some of the most interesting new medical imaging technologies on the
Toshiba Medical Rolls Out Interactive Learning Tools for Ultrasound and Vascular Training
News | Ultrasound Imaging | December 04, 2017
Toshiba Medical, a Canon Group company, introduced new educational tools and interactive learning resources to help...
Philips Azurion Platform Improves Clinical Workflow and Staff Experience Benefits
News | Angiography | December 04, 2017
Philips recently announced the results of a comprehensive, independent, two-year study demonstrating the clinical...
Eizo Presents a New Large-Format 4K UHD Monitor for Interventional Radiology and Endoscopy
Technology | Flat Panel Displays | November 20, 2017
Eizo announced in October the release of the new 55-inch 4K UHD monitor CuratOR LX550W for use in interventional...
Philips Azurion Image-Guided Therapy Platform Improves Clinical Workflow for Interventional Procedures
News | Angiography | November 15, 2017
Philips announced the results of a comprehensive, independent, two-year study demonstrating the clinical workflow...
UnityPoint Health Installs Infinix-i 4-D CT System for Interventional Procedures
News | Interventional Radiology | November 08, 2017
November 8, 2017 — Physicians at UnityPoint Health Methodist, Peoria, Ill., are now offering fast, safe and accurate
Toshiba Highlights Interventional Imaging at RSNA 2017
News | Interventional Radiology | September 27, 2017
Toshiba Medical announced it will highlight several of its latest vascular and interventional imaging solutions at the...
Overlay Init