Ivantis launches 2nd IDE study of Hydrus microstent

Ivantis said today it won approval from the FDA to initiate a 2nd investigational device exemption trial of its Hydrus microstent, testing the device in patients with advanced glaucoma who are undergoing stand-alone glaucoma surgery without combined cataract surgery. The Hydrus microstent is designed for minimally invasive microsurgical procedures to reduce eye pressure in patients with glaucoma. The device is multi-modal, the company said, by creating a large opening through the trabecular meshwork and dilating and scaffolding the conventional pathway through which fluid exits the eye. In the newly approved Summit trial, Ivantis will explore the use of the Hydrus microstent in more advanced glaucoma cases, with hopes of showing that the device exhibits the safety and efficacy required for later-stage approaches. “Thanks to the advent of minimally invasive glaucoma surgery, we now have several tools in our armamentarium to treat this disease effectively. However, as we move into the more advanced glaucoma cases, we often need to sacrifice safety to achieve the necessary efficacy required to lower intraocular pressure. The fact that Hydrus has the potential to be used on both ends of the glaucoma spectrum is an important differentiator since, from a labeling standpoint, no MIGS device has yet demonstrated the safety and efficacy to be considered for such broad use,” trial medical monitor Dr. Thomas Samuelson said in a prepared statement. The trial will analyze th...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Clinical Trials Food & Drug Administration (FDA) Optical/Ophthalmic Ivantis Source Type: news