Glaukos seeks FDA IDE nod for iStent infinite trial

January 3, 2018 By Fink Densford Leave a Comment

Glaukos (NYSE:GKOS) said today it submitted an investigational device exemption application to the FDA as it looks to launch a study of its iStent infinite trabecular micro-bypass system.

The San Clemente, Calif.-based company’s iStent infinite is designed to reduce elevated intraocular pressure in patients with refractory glaucoma, and includes three heparin-coated titanium stents and an auto-injection system. The stents are designed to be injected around the Schlemm’s canal to allow the natural physiological outflow of aqueous humor to lower IOP, Glaukos said.

Glaukos is looking to launch a prospective, multi-center, single-arm clinical trial exploring the safety and performance of the iStent infinite in approximately 65 subjects, with a primary endpoint of a 20% or greater reduction in IOP from baseline at 12 months on the same or fewer medications. Trial results are planned to be used as the basis for seeking FDA 510(k) clearance.

“We look forward to working cooperatively with the FDA as they review our IDE application – an application that marks another milestone achievement towards our goal to deliver a comprehensive pipeline of micro-scale glaucoma devices and sustained therapy pharmaceuticals. We believe the iStent infinite will be an important addition to our product offering by providing ophthalmic physicians and their refractory glaucoma patients an attractive micro-invasive treatment alternative to more invasive and complex surgical interventions,” prez & CEO Thomas Burns said in a press release.

Last week, Glaukos said it filed for pre-market approval from the FDA for its iStent Inject trabecular micro-bypass stent for treating glaucoma.

DeviceTalks Boston is Bigger and Better than Ever!

Join us Oct. 8-10 for the 7th annual DeviceTalks Boston, back in the city where it all began.

DeviceTalks offers three days of world-class education, networking, and a technology exhibition featuring the leading companies in the industry.

Early Registration is now open.

Key Surgical acquires Encompas Unlimited
Key Surgical recently announced that it has acquired Encompas Unlimited to expand its endoscopy product offerings. The financial details of the deal were not disclosed. This is the second acquisition that Key Surgical has completed after merging with Interlock Medizintechnik last year. Emcompas specializes in manufacturing, assembling and distribution a variety of endoscopy accessories and […]
Here are the top 5 medtech stories of mid-2018
A growing U.S. trade war with China and other countries casts a pall on medtech — and U.S. business in general — in mid-2018. The landscape of the medical device industry continues to evolve, though. There’s a major corporate spinout in the works, as well as a mega-merger that apparently was not to be. Read […]
Medtech stories we missed this week: July 13, 2018
From Angiodroid receiving CE Mark approval to Masimo launching its vital signs app, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Angiodroid wins CE Mark for Angiopulse IABP Angiodroid announced in a July 11 press releasethat it has received CE Mark approval for its AngioPulse intra-aortic balloon pump […]
OCTANe wraps up Ophthalmology Technology Summit
OCTANe recently hosted its annual Ophthalmology Technology Summit (OTS) where hundreds of industry leaders, investors and physicians attended to learn about ophthalmology trends and innovations. The company says that the event say significant growth this year with over 400 attendees at the conference, which is a 35% increase in attendance, year-over-year. oTS is designed to […]
Who’s afraid of the big, bad PMAs?
PMAs at FDA are often a scary process for medical devices developers. But that doesn’t have to be the case, according to Michael Drues, a regulatory consultant based outside Boston who has worked with both medical device companies and FDA. There are many myths around premarket approval, such as the idea that PMAs always require […]
Gerresheimer to acquire Sensile Medical and its drug-delivery tech
Gerresheimer plans to acquire Swiss medical technology company Sensile Medical and its array of liquid drug delivery devices. The buyout is a perfect fit in Gerresheimer’s portfolio, the company explained, since it will boost Gerresheimer’s drug delivery offerings and add new digital and electronic capabilities into the mix. Get the full story at our sister site, Drug Delivery […]
GW Plastics promotes new leaders to executive team
GW Plastics recently announced that it has appointed three new leaders to its executive team. Cathy Tempesta has been appointed to VP of human resources at GW Plastics. She has been with the company for 15 years as the director of human resources. Tempesta will be responsible for bringing the best practices to GW Plastics’s […]
Schott to acquire Primoceler and its glass micro-bonding packaging tech
Schott (Mainz, Germany) recently announced that it has agreed to acquire Primoceler Oy and its hermetic packaging portfolio with glass micro-bonding technology. The Primoceler technology out of Finland is meant to enable the manufacture of vacuum-tight, ultra-miniature, ultra-reliable medical implants. Financial terms of the deal, announced Monday, were not disclosed. Primoceler’s glass bonding method is based […]
Dune Medical debuts waste-saving surgical probe
Dune Medical Devices has designed a reposable version of its MarginProbe radiofrequency spectropscopy device, which can help surgeons identify remaining cancer cells in real time during a lumpectomy. The updated MarginProbe has a reusable cable and handle and a single-use attachable probe. It has the potential to reduce waste burden of the MarginProbe up to […]
Medline buys Canadian stroke rehab device maker NeuroGym
Medline has acquired physical therapy and rehabilitation equipment maker NeuroGym Technologies of Ottawa, Ontario. NeuroGym’s equipment is designed for people who have had a stroke or other traumatic brain injury, spinal cord injury, chronic neurological conditions such as multiple sclerosis, balance issues and/or the need for fall prevention therapy. The equipment requires the patient to initiate […]
Viant expands leadership team with former Medtronic, Integer executives
The newly rebranded Viant is expanding its leadership team after completing the acquisition of Advanced Surgical and Orthopedics. Viant, formerly known as MedPlast, has appointed former Medtronic executive Sean Crowley to chief operating officer. The company has also appointed former Integer executive Declan Smyth to group president of Advanced Surgical and Orthopedics. Crowley has more […]