Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


iStent gets panel nod

This article was originally published in The Gray Sheet

Executive Summary

An FDA advisory panel July 30 offered strong support to an implantable glaucoma treatment up for PMA approval. The Ophthalmic Devices Panel voted 7-1 that the benefits of Glaukos Corp.'s iStent trabecular micro-bypass stent outweigh the risks. The advisors voted by the same margin that they had reasonable assurance the device would be safe, and 6-2 that there was a reasonable assurance of effectiveness. If approved, iStent would be indicated for use in conjunction with cataract surgery for the reduction of intraocular pressure in patients with mild to moderate open-angle glaucoma who are being treated with ocular hypotensive medication. It would be the first shunt-type device indicated for non-refractory glaucoma, according to FDA. The agency and Glaukos agreed to long-term post-approval studies prior to the meeting, and the panel also recommended that a device registry be established

You may also be interested in...

Glaukos Awaits iStent Approval, And New Randomized Trial Requirement

Glaukos will likely have to conduct a new, five-year prospective randomized post-market study for its iStent glaucoma device if FDA approves the product's PMA

Coronavirus Update: UK Calls For COVID-19 Patients To Join Trials

GSK creates another partnership centered on its vaccine adjuvant technology, this time with China's Xiamen Innovax.

Manpower Not Materials Could Hold German COVID-19 Testing Back

Lab testing for COVID-19 has risen to a new high of 314,000 tests per week in Germany, where the concerns are perhaps less about test availability than staff numbers to oversee the testing protocols.





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts