Technology | Structural Heart Occluders | June 10, 2019

Gore Cardioform ASD Occluder Receives FDA Approval

Data from Gore ASSURED Clinical Study demonstrated 100 percent closure success for atrial septal defects at six months

Gore Cardioform ASD Occluder Receives FDA Approval

June 10, 2019 – W. L. Gore & Associates (Gore) announced the U.S. Food and Drug Administration’s (FDA’s) premarket approval (PMA) of the Gore Cardioform ASD Occluder for the percutaneous closure of ostium secundum atrial septal defects (ASDs). The FDA approval was supported by data collected from the pivotal stage of the Gore ASSURED Clinical Study, which demonstrated 100 percent closure success at the six-month evaluation in patients with a successful implant.

The pivotal study evaluated the safety and efficacy of ASD closure using the Gore Cardioform ASD Occluder in 125 patients with evidence of right heart volume overload demonstrating the need for defect closure. The study involved patients between the ages of 2 and 84, across 22 investigation sites, including 15 children’s hospitals. The pivotal study met its safety, closure and technical success primary endpoints.

“The FDA approval of the Gore Cardioform ASD Occluder is a significant milestone for innovation in the minimally invasive treatment of ASDs," said Matthew J. Gillespie, M.D., Children’s Hospital of Philadelphia, co-principal investigator of the ASSURED Study. “This soft, conformable device was not previously available for this range of defects but is now an option for larger defects that typically have a greater risk for complications, including right heart enlargement, atrial fibrillation and pulmonary hypertension. The ability to retrieve and reposition the Gore Cardioform ASD Occluder helps me ensure proper positioning and offers me confident closure.”

The device’s anatomically adaptable waist conforms to the defect to close ASDs from 8 to 35 mm in diameter, including those without a retro-aortic rim, by facilitating optimal tissue ingrowth, while maintaining thromboresistance. As the latest extension to the Gore Cardioform Occluder family, it builds on a legacy of safety outcomes.

In addition to the Gore Cardioform ASD Occluder, the occluder portfolio also includes the Gore Cardioform Septal Occluder, which is indicated for ASD closure for defects up to 17 mm and received FDA approval in 2018 for patent foramen ovale (PFO) closure to prevent recurrent ischemic stroke. Approval for the Gore CARDIOFORM Septal Occluder was supported by positive results announced in May 2018 from the Gore REDUCE Clinical Study, which demonstrated the safety and efficacy of PFO closure with a Gore device plus antiplatelet therapy compared to antiplatelet therapy alone in patients with a PFO and history of cryptogenic stroke.

For more information: www.gore.com

Related Content

FDA Issues Final Guidance on Live Case Presentations During IDE Clinical Trials
News | Cardiovascular Clinical Studies | July 10, 2019
The U.S. Food and Drug Administration (FDA) issued the final guidance “Live Case Presentations During Investigational...
Veradigm Partners With American College of Cardiology on Next-generation Research Registries
News | Cardiovascular Clinical Studies | July 03, 2019
The American College of Cardiology (ACC) has partnered with Veradigm, an Allscripts business unit, to power the next...
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
Overlay Init