iSTAR Medical (Isnes, Belgium) has insight for eyesight with the development of an innovative ophthalmic implant to treat Glaucoma.

Another wonderful story has unfolded in Belgium with the creation of iSTAR Medical SA (Isnes, Belgium), a subsidiary of Healionics Corporation (Seattle, USA), a company specializing in the development and manufacturing of STAR® Biomaterials for implanted medical devices.

With their mission to improve the lives of patients suffering from eye diseases and disorders, iSTAR’s initial focus has been to develop ophthalmic implants made from STAR® Biomaterial for treating glaucoma. Following cataracts, glaucoma, a progressive eye disease that leads to blindness, is the second leading cause of blindness that is expected to affect approximately 80 Million people worldwide by 2020.

The story begins in 2010, when iSTAR Medical SA, a privately held ophthalmic device company, was created in Wallonia with the intent purpose of developing an innovative “next generation” ophthalmic implant using STAR® Biomaterial. With the support and initial funding from both the Wallonia Region and AWEX, iSTAR Medical was given the opportunity to take their first steps towards achieving their mission. In their early stages of development, this funding helped begin the crucial path towards a European clinical study and the eventual submission for a CE Mark for their first device – STARflo™ glaucoma implant.

So what exactly is this implant device?
The STARflo™ Glaucoma Implant is a non-degradable, precision-pore implant made from STAR® Biomaterial that aims to offer a better healing, cost-effective, drainage device for improving intraocular pressure (IOP) management in patients suffering from glaucoma. From a more scientific standpoint, it is designed to operate as a bleb-free microporous drainage system to reduce IOP in patients suffering from open angle glaucoma by augmenting the eye’s natural uveoscleral outflow. The innovative STAR® Biomaterial technology is designed to induce a favorable integrated healing response by overcoming the foreign body reaction (FBR), fibrotic reactions and infection issues that would otherwise inhibit medical device performance and longevity.

As the story unfolds, through continued dedication and the collaborative team efforts carried out since its launch, by mid 2012, iSTAR Medical SA, had been granted the ISO and EEC certifications they were hoping for. These internationally recognized quality standards are extremely important in that they ensure that medical device manufacturers have the necessary quality management systems in place to safely design, develop, manufacture and distribute medical devices. This ISO certification was yet another critical steppingstone that allowed them to continue on their path towards the approval of the STARflo™ Glaucoma Implant that would eventually create an opportunity for distribution in the European Union.

Within the same time frame they were also granted the CE Mark of approval enabling commercialization in the European Union as well as in the Asian and Latin American countries that recognize the CE Mark. This approval would allow the exciting opportunity for them to introduce the STARflo™ Glaucoma Implant to additional ophthalmologists and their patients over the next several months as they entered the post-market, limited-rollout phase for this innovative device.

Alongside these major milestones, the STAR® Biomaterial was recently selected for the cover of Biotechnology and Bioengineering (August 2012) which shows biointegrated tissue inside a STARflo™ Glaucoma Implant in a rabbit eye. The STAR® Biomaterial is also featured in the peer-reviewed cover story, “Engineering Biomaterials to Integrate and Heal: The Biocompatibility Paradigm Shifts”, which reviews the most promising emerging strategies for overcoming the foreign body response to improve long-term performance of implanted medical devices.

Another notable step, iSTAR Medical has announced the signing of an exclusive distributor agreement with Device Technologies Australia Pty Ltd (Device Technologies). Device Technologies will distribute the STARflo™ Glaucoma Implant on an exclusive basis in Australia and New Zealand beginning the first quarter of 2013, following product registration.

Something else not to miss! The STARflo™ Glaucoma Implant is set to debut at the International Congress on Glaucoma Surgery next week. This should be an exciting opportunity for iSTAR Medical to introduce their innovative STARflo™ Glaucoma Implant and further build their relationship with the international glaucoma surgery community at such an honorable event.

iSTAR Medical’s insight for eyesight seems to have them heading in the right direction!

Meet iSTAR Medical at the 6th International Congress on Glaucoma Surgery
(ICGS), in Glasgow, Scotland from September 13-15, 2012.
Located at ICGS booth #27 and poster session #50.