Results Of Gore EMPiRE Clinical Study - Study Reports Low Major Adverse Event Rates Using The GORE Flow Reversal System

Main Category: Stroke
Also Included In: Cardiovascular / Cardiology;  Medical Devices / Diagnostics;  Clinical Trials / Drug Trials
Article Date: 17 Oct 2008 - 7:00 PDT

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L. Nelson Hopkins, MD, of the University of Buffalo and national co-principal investigator, presented results of the Gore EMPiRE Clinical Study(1) today at the 20th annual Transcatheter Cardiovascular Therapeutics scientific symposium, sponsored by the Cardiovascular Research Foundation. The investigational clinical study is designed to demonstrate the safety and efficacy of the GORE Flow Reversal System for neuroprotection during carotid artery stenting (CAS) in patients at high risk for carotid endarterectomy. The GORE Flow Reversal System provides neuroprotection by reversing the flow of blood at the carotid stenosis, thereby directing embolic particles away from the brain.

The Gore EMPiRE Clinical Study met the primary endpoint of major adverse events of death, stroke, transient ischemic attack (TIA), and myocardial infarction (MI). The 30-day stroke, death, and MI rate was 3.7 percent (4.5 percent including TIA) and the death / any stroke rate was low, at 2.9 percent, as compared to other embolic protection trials. Importantly, the study also showed encouraging results in some of the most challenging patient populations with a low death, stroke, and MI rate of 2.6 percent for octogenarians and 3.8 percent for symptomatic patients. The results of the pivotal Gore EMPiRE Clinical Study were based on the enrollment of 245 patients at 28 clinical sites.

"Over the past two years in clinical research, the GORE Flow Reversal System has proven to be an important advancement in neuroprotection during carotid artery stenting procedures," stated Dr. Hopkins. "The results are extremely promising as we strive to better protect patients and demonstrate the value of CAS in the treatment of carotid disease. With the GORE Flow Reversal System, physicians will no longer need to cross lesions unprotected, thereby reducing the risks of emboli going to the brain and causing a stroke."

Daniel G. Clair, MD, FACS, of the Cleveland Clinic Foundation and national co-principal investigator for the Gore EMPiRE Clinical Study stated, "The GORE Flow Reversal System is not only a significant advancement in neuroprotection, it is an important step forward for carotid stenting that may help establish CAS as the therapy of choice for a greater number of patients."

Samantha Powis, PhD, Product Specialist for the GORE Flow Reversal System explained that, "The GORE Flow Reversal System is a unique embolic protection system that operates on the principle of reversing the flow of blood at the treatment site. Unlike available embolic protection devices, flow reversal enables physicians to perform carotid interventions knowing that micro and macro emboli will be directed away from the brain." Flow reversal is achieved at the treatment site by selectively occluding common carotid and external carotid artery blood flow. By establishing a shunt between the carotid artery and femoral vein, blood from the collateral vessels is redirected to the lower pressure venous return. Redirected blood is filtered outside the body before being reintroduced into the venous system.

The findings of the Gore EMPiRE Clinical Study underline Gore's long-term commitment to carotid stenting and stroke interventions. Gore is conducting other studies in the area of stroke intervention including the Gore REDUCE Clinical Study(2) evaluating the GORE HELEX Septal Occluder for patent foramen ovale closure and stroke prevention, and the Gore EMBOLDEN Clinical Study(3) evaluating the GORE Embolic Filter in CAS.

(1) EMPiRE: Embolic Protection with Reverse Flow Study of the GORE Flow Reversal System in Carotid Stenting of Subjects at High Risk for Carotid Endarterectomy

(2) REDUCE: GORE HELEX Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke or Imaging-Confirmed TIA in Patients with Patent Foramen Ovale (PFO)

(3) EMBOLDEN: GORE Embolic Filter in Carotid Stenting for High Risk Surgical Subjects

ABOUT W. L. GORE & ASSOCIATES

The Gore Medical Products Division has provided creative therapeutic solutions to complex medical problems for three decades. During that time, more than 25 million innovative Gore Medical Devices have been implanted, saving and improving the quality of lives worldwide. The extensive Gore Medical family of products includes vascular grafts, endovascular and interventional devices, surgical meshes for hernia repair, soft tissue reconstruction, staple line reinforcement and sutures for use in vascular, cardiac and general surgery. Gore was recently named one of the best companies to work for by Fortune magazine for the 11th consecutive year. For more information, visit http://www.goremedical.com.

Caution: Investigational Device. Limited by Federal (or United States) Law to Investigational Use. These claims have not been evaluated by FDA. These data will support premarket notification to FDA seeking clearance to market this device.
Products listed may not be available in all markets pending regulatory clearance. GORE and HELEX are trademarks of W. L. Gore & Associates. AM1022-EN1 October 2008