Ivantis Hits 2 Major Milestones for its Minimally Invasive Glaucoma Surgery (MIGS)

January 8, 2018

In October, Ivantis completed its pre-market approval for Hydrus Microstent, its Minimally Invasive Glaucoma Surgery procedure. Dave Van Meter, president and CEO of Ivantis, elaborates further on the importance of this milestone: “The submission of Ivantis’ PMA marks a significant milestone toward our goal of bringing the Hydrus Microstent to market in the United States in 2018, and we look forward to the FDA’s review. We want to acknowledge the significant effort and contributions from the investigators and clinical sites around the world who participated in the HORIZON Study. The HORIZON Study underscores our commitment to a rigorous, evidence-based approach to evaluating the Hydrus Microstent. On the heels of the prior HYDRUS II Trial, this allows Hydrus to become the first MIGS technology evaluated in two well-controlled trials, conducted in accordance with the ANSI Standard for implantable glaucoma devices, the highest level of evidence defined by the Food and Drug Administration.”

Then, in November, Ivantis exceeded its previous outcomes for MIGS, marking a major milestone. Van Meter noted the importance of the results in the latest announcement:

“With these results, we’ve been able to demonstrate best-in-class clinical evidence in another top-level randomized controlled trial utilizing the ANSI Standard for implantable glaucoma devices, the highest level of evidence defined by the Food and Drug Administration. These excellent results give us great confidence that the Hydrus Microstent can become the standard of care for both cataract and glaucoma surgeons for the majority of their glaucoma patients undergoing cataract surgery.”