Home

Press Releases

About

Editorial

Advertise

Cookie Policy

Privacy

Contact

MEDICAL DEVICE NEWS MAGAZINE

A DIGITAL PUBLICATION FOR THE PRACTICING MEDICAL SPECIALIST, INDUSTRY EXECUTIVE AND INVESTOR

SUBSCRIBE

Market Reports

FDA

Executives

Funding

Non Profits

Hospitals

Acquisitions

Health

Biotechnology News Magazine

iSTAR Medical Receives U.S. FDA Approval to Commence Pivotal Trial for MINIject in Glaucoma Patients

Share the News

iSTAR Medical, a med-tech company developing minimally-invasive implants for glaucoma surgery (MIGS), announced today that the U.S. Food and Drug Administration (FDA) granted it Investigational Device Exemption (IDE) to start a pivotal trial with MINIjectTM. The STAR-V study will investigate MINIjectTM in over 350 patients with primary open angle glaucoma. World-leading glaucoma surgeons in the US, Canada and Europe will join the trial.

The STAR-V trial evaluates MINIject’s efficacy by the mean reduction in eye pressure, as well as the proportion of patients achieving at least a 20 percent reduction in eye pressure. This study will report on safety and efficacy of MINIject alone, in a procedure not combined with simultaneous cataract surgery. Key study findings will become available when all patients have completed 2 years in the study. Patients will also be followed to evaluate long-term benefits and tolerability of MINIjectTM in the treatment of mild to moderate glaucoma.

Dr. Brian E. Flowers, a glaucoma specialist at Ophthalmology Associates of Fort Worth, TX, USA said.

MINIject is iSTAR Medical’s revolutionary MIGS device for patients with primary open-angle glaucoma. MINIject combines the unique porous structure of its proprietary STAR material with the power offered by the supraciliary space. As a result, it is designed to enhance natural fluid outflow, reducing intraocular pressure (IOP) and the need for medication, while bio-integrating with surrounding tissue, limiting inflammation, fibrosis and subsequent complications.

spot_img