News | November 04, 2011

International Study Examines Effectiveness of Gore Helex for PFO Closure in Patients With Cryptogenic Stroke

November 4, 2011 – W. L. Gore & Associates announced that Royal Sussex County Hospital in Brighton, United Kingdom, is the first medical center in the United Kingdom to enroll a patient in the Gore REDUCE clinical study. The study is a U.S. Food and Drug Administration (FDA)-approved prospective, randomized, multi-center, international trial designed to demonstrate safety and effectiveness of the Gore HELEX septal occluder for patent foramen ovale (PFO) closure in patients with a history of cryptogenic stroke or imaging-confirmed transient ischemic attack (TIA). The unique study includes up to fifty investigational sites in the United States and Europe. This patient enrollment was achieved by the site’s study investigator, David Hildick-Smith, M.D., director of cardiac research unit, Brighton and Sussex University Hospitals.


“Royal Sussex County Hospital is honored to take part in this international trial with the hope of advancing treatment options for patients suffering from a history of cryptogenic strokes,” said Hildick-Smith.

Patients in the Gore REDUCE Clinical Study are randomized to one of two treatment arms, either anti-platelet medical management alone or device closure of the PFO in conjunction with anti-platelet medical management. The primary endpoint is freedom from recurrent ischemic stroke, TIA or death due to stroke through 24 months post-randomization.

The FDA approved the Gore HELEX septal occluder for treatment of atrial septal defect (ASD), a congenital heart defect, in 2006. The device received CE Mark for ASD and PFO closure in 1999. Participation in the Gore REDUCE Clinical Study by centers in the United Kingdom and Nordic countries is helping to drive enrollment in this pivotal trial.

The Gore HELEX Septal Occluder is composed of ePTFE material supported by a single-wire nitinol frame. Over the course of several weeks to months following implantation of the device, cells begin to infiltrate and grow over the ePTFE material, aiding in the successful closure of the defect.

For more information: www.goremedical.com

 

Related Content

New FDA Proposed Rule Alters Informed Consent for Clinical Studies
News | Cardiovascular Clinical Studies | November 19, 2018
The U.S. Food and Drug Administration (FDA) is proposing to add an exception to informed consent requirements for...
A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development. #SCAI, #SCAI2018

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development.  

Feature | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 – New clinical evidance shows common therapy options for psoriasis (PSO), a chronic inflammatory skin di
Intravenous Drug Use is Causing Rise in Heart Valve Infections, Healthcare Costs. #SCAI, #SCAI2018
News | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 — The opioid drug epidemic is impacting cardiology, with a new study finding the number of patients hosp
Patient Enrollment Completed in U.S. IDE Study of THERMOCOOL SMARTTOUCH SF Catheter
News | Cardiovascular Clinical Studies | March 15, 2018
March 15, 2018 –  Johnson & Johnson Medical Devices Companies announced today that Biosense Webster, Inc., who wo
Lexington Begins HeartSentry Clinical Trial
News | Cardiovascular Clinical Studies | February 20, 2018
February 20, 2018 – Lexington Biosciences, Inc., a development-stage medical device company, announced the commenceme
Endologix Completes Patient Enrollment in the ELEVATE IDE Clinical Study
News | Cardiovascular Clinical Studies | February 06, 2018
February 6, 2018 – Endologix, a developer and marketer of treatments for aortic disorders, announced the completion o
12-Month Results from Veryan Medical's MIMICS-2 IDE Study Presented at LINC
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 – Thomas Zeller (Bad Krozingen, Germany) presented the 12-month results from Veryan Medical’s MIMICS
LimFlow Completes U.S. Feasibility Study Enrollment, Receives FDA Device Status
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 –  LimFlow SA, developer of minimally-inv
ESC 2017 late breaking trial hot line study presentations.
News | Cardiovascular Clinical Studies | September 12, 2017
September 12, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking C
U.K., NHS studies, weekend effect, hospital admission, atrial fibrillation, heart failure
News | Cardiovascular Clinical Studies | June 28, 2016
New research shows patients admitted to National Health Service (NHS) hospitals in the United Kingdom for atrial...
Overlay Init