• Product: GORE HELEX Septal Occluder (remove)
  • Term: GORE HELEX Septal Occluder
Showing 1 to 8 of 8 Results
Rush University Medical Center First to Enroll Patient in the Gore REDUCE Clinical Study for the Indication of Patent Foramen Ovale (PFO) Closure
11 December 2008 - Multi-national trial to demonstrate safety, effectiveness of GORE HELEX Septal Occluder for PFO closure in patients with a history of cryptogenic stroke
Gore Receives Approval from FDA for Unique Patent Foramen Ovale Stroke Study
05 May 2008 - Multinational trial randomizes stroke patients with Patent Foramen Ovale (PFO) to closure with the GORE HELEX Septal Occluder versus medical management
Gore Provides Update on Patent Foramen Ovale (PFO) Stroke Study
08 July 2010 - Gore Reaffirms Commitment to Multi-National, Randomized Study on PFO Closure in Stroke Patients using GORE® HELEX Septal Occluder Versus Medical Management
Can the GORE HELEX Septal Occluder be repositioned?

Yes, the GORE HELEX Septal Occluder can be withdrawn into the catheter and repositioned before the lock has been set.

Can the GORE HELEX Septal Occluder be recaptured?

Yes, in case of embolization, the GORE HELEX Septal Occluder can be recaptured using a snare or other interventional tools.

FDA Approves GORE HELEX Septal Occluder for Treatment of Atrial Septal Defect
03 October 2007 - W. L. Gore & Associates today announced that the US Food & Drug Administration (FDA) granted approval for the GORE HELEX Septal Occluder with modified catheter delivery system indicated for the transcatheter closure of atrial septal defect (ASD).
How is the GORE HELEX Septal Occluder deployed?

See the GORE HELEX Septal Occluder Instructions for Use.

Can the GORE HELEX Septal Occluder be retrieved?

Yes, the GORE HELEX Septal Occluder can be retrieved using the retrieval cord after the lock has been set.

Showing 1 to 8 of 8 Results