Healthcare Industry News:  Patent foramen ovale 

Devices Interventional

 News Release - March 10, 2009

Gore Announces First Patient Treated With Recently-Cleared GORE Flow Reversal System

Breakthrough Gore System Provides Neuroprotection During Carotid Artery Stenting by Reversing Blood Flow at the Treatment Site

FLAGSTAFF, Ariz.--(HSMN NewsFeed)--W. L. Gore & Associates (Gore) today announced the first clinical use of the GORE Flow Reversal System for neuroprotection during carotid artery stenting (CAS). Gore obtained 510(k) clearance from the US Food and Drug Administration (FDA) for the system in February. The procedure was performed by Daniel McCormick, MD and Sheldon Goldberg, MD, Interventional Cardiologists at Hahnemann University Hospital, Philadelphia, Pennsylvania. The GORE Flow Reversal System is a new technology which minimizes the risk of emboli reaching the brain during critical stages of CAS, thereby expanding treatment options for broad patient populations with carotid artery disease.

“We are pleased to be the first site to perform a procedure using the commercially available GORE Flow Reversal System,” said Dr. McCormick. “I believe this new development in carotid artery stenting is a promising advancement in the treatment of carotid disease.”

The first patient was recently symptomatic with an extreme aortic arch and a string sign lesion in the internal carotid artery. The lesion was successfully treated under neuroprotection using the GORE Flow Reversal System. The patient was discharged from the hospital and is doing well.

“I was impressed that the GORE Flow Reversal System negotiated the Type III aortic arch with ease,” stated Dr. McCormick. “Treating this extremely tight stenosis and challenging arch anatomy under flow reversal provided me with a level of performance and confidence that would have been improbable with other embolic protection devices.”

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 technology that establishes neuroprotection by reversing blood flow 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.

Prior to the procedure, Dr. McCormick attended a GORE MEDICAL MASTERY SERIES, Flow Reversal Course to gain familiarity with the GORE Flow Reversal System. This course allows clinicians to perform simulated carotid artery procedures using the product and educates physicians on how flow reversal makes the promise of carotid artery stenting possible.

“We are pleased Dr. McCormick had a positive clinical experience with the GORE Flow Reversal System and that the GORE MEDICAL MASTERY SERIES, Flow Reversal Course helped prepare him for the procedure,” said Stuart Broyles, PhD, Stroke Interventions Business Unit Leader at Gore. “The GORE Flow Reversal System is an important step forward 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.

*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 http://www.goremedical.com.

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

Indications for Use: The GORE Flow Reversal System is intended to provide embolic protection during carotid artery angioplasty and stenting for patients diagnosed with carotid artery stenosis and who have appropriate anatomy as described in the Instructions for Use. Refer to the Instructions for Use for contraindications, warnings and precautions.

Products listed may not be available in all markets pending regulatory clearance. GORE and HELEX are trademarks of W. L. Gore & Associates. AN0117-EN1 MARCH 2009.


Source: W. L. Gore

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