Gore Releases Three-Year Data Demonstrating the Efficacy of the GORE CARDIOFORM ASD Occluder

This week, W. L. Gore & Associates, otherwise known as Gore, announced the release of three-year data from the Gore ASSURED Clinical Study (ASSURED Study) which demonstrated long-term safety and efficacy of the GORE CARDIOFORM ASD Occluder at six, 12, and 36 months, with 100% closure success across a broad range of ASD anatomies, including patients with deficient retro-aortic rims.

In this prospective, multicenter trial, which took place across 22 sites, researchers assessed the efficacy of the GORE CARDIOFORM ASD in 569 patients.

They  successfully implanted the device in 92.4% of patients, noting a low rate of reported 30-day device/procedure-related serious adverse events (SAEs) (3.7%), as well as a low rate of device events (4.1%), and clinically significant new arrhythmia (4.2%) through 36 months. Moreover, at three years, the composite clinical success rate — as defined by satisfying achievement of technical success, safety success and closure success — was observed at a robust 84%.

“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.

“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.”