News | October 28, 2019

Gore Receives European Approval For Cardioform ASD Occluder For Atrial Septal Defects

CE mark supported by data from the Gore ASSURED Clinical Study, demonstrating 100 percent closure success

The Gore Cardioform ASD Occluder received European CE mark clearance in early October. The device offers a percutaneous, transcatheter closure option for the ostium secundum atrial septal defects (ASDs).

October 28, 2019 — The Gore Cardioform ASD Occluder received European CE mark clearance in early October. The device offers a percutaneous, transcatheter closure option for the ostium secundum atrial septal defects (ASDs).

The Gore ASSURED Clinical Study demonstrated safety, closure and technical success that statistically achieved the primary endpoint. The new addition to the Gore portfolio extends the Gore Cardioform occluder family.

The ASD occluder’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 thrombo-resistance. The ability to retrieve and reposition the Ccardioform ASD Occluder helps ensure proper positioning and offers confident closure, the vendor said.

“Larger defects typically have a greater risk for complications, like pulmonary hypertension, right heart enlargement, or atrial fibrillation. But previously, Europe didn’t have access to the Gore Cardioform ASD Occluder for this range of defects,” said Matthew Gillespie, M.D., Children’s Hospital of Philadelphia, co-principal investigator of the ASSURED Clinical Study. “CE mark makes this soft, conformable device available for the minimally invasive treatment of a broader range of ASDs.”

The pivotal study evaluated the safety and efficacy of ASD closure using the 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 Cardioform ASD Occluder was recently granted approval by the U.S. Food and Drug Administration (FDA) for the treatment of atrial septal defects and is the newest addition in Gore’s occluder portfolio. The portfolio also includes the Cardioform Septal Occluder, which is indicated for ASD closure for defects up to 17 mm and received FDA clearance in 2018 for patent foramen ovale (PFO) closure to prevent recurrent ischemic stroke. In May 2018, positive results were announced 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

Gallery | Cath Lab | October 31, 2019
This is a photo essay of the interventional cardiology and structural heart technologies on the expo floor and discus
The Alphenix Aero Package from Canon Medical Systems USA, Inc. enables OBLs and ASCs to attain premium technology at a flexible price point by tailoring Canon Medical’s Alphenix systems to fit their facilities’ needs.

The Alphenix Aero Package from Canon Medical Systems USA, Inc. enables OBLs and ASCs to attain premium technology at a flexible price point by tailoring Canon Medical’s Alphenix systems to fit their facilities’ needs.

Technology | Cath Lab | October 28, 2019
Office based labs (OBLs) and ambulatory surgery centers (ASCs) require a fresh perspective from imaging vendors.
Marco Costa, M.D., Ph.D., MBA, president, UH Harrington Heart and Vascular Institute, performing a cath lab procedure.

Marco Costa, M.D., Ph.D., MBA, president, UH Harrington Heart and Vascular Institute, performing a cath lab procedure.

News | Cath Lab | October 28, 2019
October 28, 2019 — Leaders within University Hospitals and the Harrington Heart and Vascular Institute had a vision t
OmniVision Announces Guinness World Record for Smallest Image Sensor

OmniVision's OVM6948 CameraCubeChip, a fully packaged, wafer-level camera module measuring 0.65mm x 0.65mm x 1.158mm, built on OmniVision's OV6948, winner of the Guinness World Record for “The Smallest Image Sensor Commercially Available.”

News | Cath Lab | October 22, 2019
October 22, 2019 — OmniVision Technologies Inc.
People watch the presentation of the five-year EXCEL Trial data by Gregg Stone, M.D., live in the Abbott booth at TCT 2019. Abbott makes the Xience stent used in the trial, which compared equally with long term surgical outcomes. #TCT2019

People watch the live presentation of the five-year EXCEL Trial data by Gregg Stone, M.D., in the Abbott booth at TCT 2019. Abbott makes the Xience stent used in the trial, which compared equally with long-term CABG surgical outcomes. 

Feature | Cath Lab | October 03, 2019
October 3, 2019 – Five-year data from the EXCEL Trial showed patients with left main coronary disease treated with pe
Two Stents Implanted in Democratic Presidential Candidate Bernie Sanders, suffers chest pain
News | Cath Lab | October 02, 2019 | Dave Fornell, Editor
October 2, 2019 — Democratic presidential candidate Sen.
Bypass Surgery and Coronary Stenting Yield Comparable 10-Year Survival
News | Cath Lab | September 25, 2019
Ten-year survival rates are similar for bypass surgery and coronary stenting with drug-eluting stents in randomized...
Complete Revascularization Superior to Culprit Lesion-only Intervention
News | Cath Lab | September 10, 2019
An international randomized trial has shown that complete revascularization reduces major cardiovascular events...
The cath lab staff UH Portage Medical Center.

The cath lab staff UH Portage Medical Center.

Feature | Cath Lab | September 09, 2019 | Anjan Gupta, M.D., FACC, FSCAI
Primary percutaneous coronary intervention (PCI) is the preferred treatment for acute...
Overlay Init