Gore’s Cardioform ASD Occluder Evaluated at 3 Years in ASSURED Trial

September 30, 2024—Gore & Associates announced the release of 3-year data from the ASSURED clinical study, which is evaluating the long-term safety and efficacy of treating ostium secundum atrial septal defects (ASDs) with the company’s Cardioform ASD occluder. The study included a broad range of ASD anatomies, including patients with deficient retro-aortic rims.

According to Gore, the ASSURED data demonstrated long-term safety and efficacy of the Cardioform device at 6, 12, and 36 months, with 100% closure success rate among patients evaluated at 36 months (n = 357).

As summarized in the company’s press release, the prospective, multicenter, single-arm comparison study was designed using performance goals derived from clinical study outcomes for devices indicated for ASD closure.

Gore stated that the results include the previously reported pivotal cohort (n = 125) 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 to 35 mm by stop-flow balloon sizing.

The ASSURED investigators at 22 sites implanted the Cardioform ASD occluder in 92.4% of patients (n = 569) with a low rate of reported 30-day device- and procedure-related serious adverse events (SAEs, 3.7%). Through 36 months, the investigators reported low rates of device events (4.1%) and clinically significant new arrhythmia (4.2%).

At 3 years, the composite clinical success—as defined by satisfying achievement of technical success, safety success, and closure success—was 84% (351/418), stated the company.

The findings were published by Athar M. Qureshi MD, et al online in JACC: Cardiac Interventions.

“These long-term safety and efficacy outcomes speak directly to the performance and effectiveness of the Gore Cardioform ASD occluder,” commented Dr. Qureshi in Gore’s press release. “The soft and conformable design helped deliver 100% closure and a low rate of SAEs across ASD anatomies, with no reported clinical sequelae as a result of wireframe fracture in the study.”

ASSURED coprincipal investigator Robert J. Sommer, MD, added, “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.”

In 2019, the Gore Cardioform ASD occlude was approved in the United States and Europe.