Gore Associates Unveils Promising Three-Year Clinical Outcomes
Gore Associates Unveils Promising Three-Year Clinical Outcomes
W. L. Gore & Associates has made significant strides in treating atrial septal defects (ASDs) with its innovative GORE CARDIOFORM ASD Occluder. Recent results from the ASSURED Clinical Study have revealed remarkable three-year data, highlighting a 100% closure success rate. This study, which evaluates a variety of ASD anatomies, showcases the GORE CARDIOFORM ASD Occluder as a reliable solution even for patients with challenging conditions, such as those presenting deficient retro-aortic rims.
Understanding the ASSURED Study
The ASSURED Clinical Study, a multicenter, single-arm study, has meticulously tracked patients over a 36-month period to assess the long-term performance of the GORE CARDIOFORM ASD Occluder. The findings illustrate not only the durability of the occluder but also its consistent safety profile. Specifically, physicians across 22 sites successfully implanted the device in over 92% of the cases, involving a considerable cohort of 569 patients, which emphasizes the widespread trust in the occluder's efficacy.
Notable Outcomes from the Study
Over the duration of the study, the device demonstrated a low rate of serious adverse events at just 3.7%. Additionally, the reported rate of device-related occurrences was 4.1%, alongside a new-arrhythmia rate of 4.2% among the patients evaluated at the three-year mark. These numbers suggest that the GORE CARDIOFORM ASD Occluder not only excels in achieving closure but also maintains patient safety effectively.
Adequate Response to ASD Treatment
At the three-year follow-up, the composite clinical success rate, which combines technical success, safety performance, and closure efficiency, stood at an impressive 84%. This outcome indicates that three-quarters of the patients enrolled in the study experienced comprehensive benefits from the procedure and device.
Insights from Medical Experts
Robert J. Sommer, M.D., co-principal investigator of the ASSURED Study, expressed optimism about the findings, stating, "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." His statement reinforces the credibility and ongoing application of the device in clinical settings.
The Multifaceted Role of Gore Associates
W. L. Gore & Associates is known for its commitment to pushing boundaries in medical technology. With over 55 million devices implanted and a history spanning more than four decades, the company's dedication to research and development is clear. Gore's engineers focus on creating effective medical solutions that yield positive outcomes for patients across various health conditions, particularly in cardiology.
Commitment to Quality and Innovation
With annual revenues of approximately $4.8 billion and a team of over 13,000 associates, Gore thrives on collaboration with clinical professionals to enhance product performance and ensure the highest quality service. These efforts contribute to sustainable cost savings for healthcare providers, thereby benefiting the overall healthcare system.
Frequently Asked Questions
What are the main findings of the ASSURED Clinical Study?
The ASSURED Clinical Study demonstrated a 100% closure success rate and a low rate of serious adverse events, confirming the safety and efficacy of the GORE CARDIOFORM ASD Occluder over three years.
How many patients participated in the study?
A total of 569 patients were included in the ASSURED Clinical Study, with successful implantation in 92.4% of cases.
What defines clinical success in this study?
Clinical success in the ASSURED Study is defined by the achievement of technical success, safety success, and closure success, with an overall achievement rate of 84% at the three-year mark.
Who is Dr. Robert J. Sommer?
Dr. Robert J. Sommer is a co-principal investigator of the ASSURED Study and emphasizes the long-term safety and efficacy of the GORE CARDIOFORM ASD Occluder.
What is W. L. Gore & Associates known for?
W. L. Gore & Associates is a materials science company dedicated to creating solutions for various medical challenges, particularly in cardiology, with a strong focus on innovation and patient outcomes.
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