GORE Flow Reversal System Cleared by FDA





W. L. Gore & Associates (Gore) today that the US Food and Drug Administration (FDA) has given the company 510(k) clearance to market the GORE Flow Reversal System. This new technology minimizes the risk of emboli reaching the brain during critical stages of carotid artery stenting (CAS), expanding treatment options for broad patient populations with carotid artery disease.

W. L. Gore & Associates (Gore) today that the US Food and Drug Administration (FDA) has given the company 510(k) clearance to market the GORE Flow Reversal System. This new technology minimizes the risk of emboli reaching the brain during critical stages of carotid artery stenting (CAS), expanding treatment options for broad patient populations with carotid artery disease.

One of the major challenges associated with CAS is the risk of peri-procedural embolic events that could cause a stroke. The GORE Flow Reversal System is a unique neuroprotection technology that reverses the flow of blood at the treatment site prior to crossing the lesion. Flow reversal is achieved by selectively occluding common carotid and external carotid artery blood flow. By establishing an arterio-venous shunt, blood from collateral vessels via the Circle of Willis is redirected to the lower pressure venous return. Macro and micro emboli are continuously directed away from the brain during flow reversal.

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 carotid stenting as the therapy of choice for a greater number of patients."

In the Gore EMPiRE Clinical Study, the safety and efficacy of the GORE Flow Reversal System during CAS was assessed in patients at high risk for carotid endarterectomy. 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 and the death / any stroke rate was 2.9 percent. 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 from the Gore EMPiRE Clinical Study are extremely promising as we strive to better protect patients and demonstrate the value of CAS in the treatment of carotid disease. This is one of the first CAS studies to report rates within the American Heart Association guidelines for carotid endarterectomy," stated Dr. L. Nelson Hopkins of the University of Buffalo and national co-principal investigator. "We are optimistic that evolving technologies, such as the GORE Flow Reversal System, will enable CAS to become the therapy of choice in the treatment of carotid disease."

"Gore is pleased to provide the clinical and patient communities with an unsurpassed neuroprotection option for CAS procedures," said Stuart Broyles, PhD, Stroke Interventions Business Unit Leader at Gore. "The GORE Flow Reversal System is an important breakthrough for carotid disease therapy and a key part of 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** evaluating the GORE HELEX Septal Occluder for patent foramen ovale closure and stroke prevention, and the Gore EMBOLDEN Clinical Study*** evaluating the GORE Embolic Filter in CAS.

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

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)

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 12th consecutive year. For more information, visit goremedical.com .

Caution: GORE HELEX Septal Occluder for the Indication of PFO and GORE Embolic Filter are Investigational Devices. Limited by Federal (or United States) Law to Investigational Use.

Products listed may not be available in all markets pending regulatory clearance. GORE and HELEX are trademarks of W. L. Gore & Associates.

Contact:
Shannon Murphy / Andrea Hawley
Schwartz Communications, Inc. for Gore
415-512-0770
GoreMedical@schwartz-pr.com