Gore ASSURED Clinical Study results through 36 months demonstrate 100 percent closure success * with the GORE ® CARDIOFORM ASD Occluder, and consistent safety outcomes † across a broad range of ASD anatomies, ‡,1,2 including patients with deficient retro-aortic rims. § ,2 View the published study here . FLAGSTAFF, Ariz.
, Sept. 30, 2024 /PRNewswire/ -- W. L.
Gore & Associates (Gore) announced the release of three-year data from the Gore ASSURED Clinical Study (ASSURED Study) in the September 2024 online issue of JACC: Cardiovascular Interventions, evaluating the long-term safety and efficacy of treating ostium secundum ASDs with the GORE ® CARDIOFORM ASD Occluder. The ASSURED Study data demonstrated long-term safety and efficacy of the GORE CARDIOFORM ASD Occluder at 6, 12 and 36 months, with 100 percent closure success * rate among patients evaluated at 36 months (n = 357). 2 Clinical trial physicians across 22 sites successfully implanted the device in 92.
4 percent of patients (n = 569), with a low rate of reported 30-day device/procedure-related serious adverse events (SAEs) (3.7 percent), as well as a low rate of device events (4.1 percent) II, ¶ and clinically significant new arrhythmia (4.
2 percent) through 36 months. ** ,2 At three years, the composite clinical success — as defined by satisfying achievement of technical success, †† safety success ‡‡ and closure success * — was 84 percent (351/418). 2 "Completion of the 36-month follow-up in this lar.