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 - 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 larger population clearly demonstrates the device's long-term safety and closure efficacy. The GORE CARDIOFORM ASD Occluder continues to be a useful device for interventional cardiologists," said Robert J. Sommer, M.D., co-principal investigator of the ASSURED Study.
The prospective, multicenter, single-arm comparison study was designed using performance goals derived from clinical study outcomes for devices indicated for ASD closure.
Results include the previously reported pivotal cohort (n = 125)3 and patients who were enrolled in the continued access phase
(n = 444) through 36 months of follow-up for a total of 569 patients. There were no age limitations and no retro-aortic rim requirements, and all patients had ostium secundum ASDs that measured 8–35 mm by stop-flow balloon sizing.
"These long-term safety and efficacy outcomes speak directly to the performance and effectiveness of the GORE CARDIOFORM ASD Occluder," said Athar M. Qureshi, M.D., site investigator and lead author of the 36-month ASSURED Study manuscript. "The soft and conformable design helped deliver 100 percent closure and a low rate of SAEs across ASD anatomies, with no reported clinical sequelae as a result of wireframe fracture in the study."
To find out more information about the ASSURED Study and the 36-month results visit, Long-Term Results of the Atrial Septal Defect Occluder ASSURED Trial for Combined Pivotal/Continued Access Cohorts - ScienceDirect.
* Closure success is defined as a clinical residual defect status of occluded or clinically insignificant as determined by the Echo Core Lab at the 36-month evaluation among subjects with technical success.
† Safety outcomes defined as a calculation of the proportion of subjects that experienced one or more SAEs within 30 days post-index procedure or a device event (embolization, device removal, reintervention after completion of index procedure) through 6 months, 12 months and 36 months post-index procedure.
‡ All ASD anatomies within indicated sizing parameters of the Instructions for Use.
§ Deficient retro-aortic rim was defined as a retro-aortic rim measuring less than or equal to 5 mm on any view on echocardiogram.
II Device events are defined as post-procedure embolization, device removal or other device reintervention from completion of the implant procedure through 36 months post-procedure.
¶ Device event rate (n = 17/418) among patients evaluated for the clinical composite success endpoint at 36 months.
** In subjects without prior history of arrhythmia, any new arrhythmia (documented on ECG) requiring hospitalization, initiation of new long-term medical therapy (persisting > 45 days) or any post-index procedure cardioversion or intervention (pacemaker, ablation, etc.).
†† Technical success is defined as successful deployment and retention (at conclusion of index procedure) of a GORE CARDIOFORM ASD Occluder.
‡‡ Safety success is defined as freedom from any serious adverse event (SAE) related to the device or procedure (as adjudicated by the Independent Data Review Board [IDRB]) through 30 days post-procedure and freedom from device events (post-procedure embolization, device removal or other device reintervention) from completion of the implant procedure through 36 months post-procedure.
GORE® CARDIOFORM ASD Occluder [Instructions for Use]. Flagstaff, AZ: W. L. Gore & Associates, Inc; 2024. MD200690.
Qureshi AM, Sommer RJ, et al; GORE ASSURED Clinical Trial Investigators. Long-term results of the Atrial Septal Defect Occluder ASSURED Trial for combined pivotal/continued access cohorts. JACC: Cardiovascular Interventions. In press.
Sommer RJ, Love BA, Paolillo JA, et al. ASSURED clinical study: New GORE® CARDIOFORM ASD occluder for transcatheter closure of atrial septal defect. Catheter & Cardiovascular Interventions. 2020;95:1285-1295.
Gore engineers medical devices that treat a range of cardiovascular and other health conditions. With more than 55 million medical devices implanted over the course of more than 45 years, Gore builds on its legacy of improving patient outcomes through research, education and quality initiatives. Product performance, ease of use and quality of service provide sustainable cost savings for physicians, hospitals and insurers. Gore is joined in service with clinicians and through this collaboration we are improving lives. goremedical.com
For complete indications and other important safety information for Gore commercial products referenced herein, refer to the applicable Instructions for Use (IFU).
About Gore
W. L. Gore & Associates is a global materials science company dedicated to transforming industries and improving lives. Since 1958, Gore has solved complex technical challenges in demanding environments — from outer space to the world's highest peaks to the inner workings of the human body. With more than 13,000 Associates and a strong, team-oriented culture, Gore generates annual revenues of $4.8 billion. gore.com
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