Скачать или смотреть iStar Medical Developing NextGen MIGS Device

This privately held company has a “pipeline of products” to treat glaucoma, concentrating on the MINIject, a “next-generation” minimally invasive glaucoma surgery (MIGS) device. The differentiating factor for these MIGS devices is the company’s anti-fibrotic STAR material. iStar Medical's first ab externo device, (STARflo was introduced in 2014 as a proof-of-concept for the material.) The STAR material is medicalgrade silicone with “precision-pore geometry"; it is soft, flexible, and tissue friendly, CEO Michel Vanbrabant said. Unlike other MIGS devices, there is “no single lumen but rather thousands of microscopic lumens,” he said. The MINIject first-in-human study recruitment was completed in October 2017. iStar expects the CE mark in 2019; the company will file for an investigational device exemption IDE in the US in 2018; in both cases the device is for mild-to-moderate glaucoma and is being studied as both a stand-alone procedure and in conjunction with cataract surgery. The first-in-human (n=25) studies] showed feasibility, a short surgical implantation (5 minutes) through a 2-mm incision into the iridocorneal angle targeting the area between the scleral spur and ciliary body into the suprachoroidal space. There were no serious adverse events or inflammation. iStar expects additional results by April 2018.