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    Device makers swing for fence with new technologies

     

    Sanoculus

    Most MIGS devices involve implants, stitches, and the associated surgical concerns. Sanoculus has taken a different path by developing minimally invasive micro sclerostomy, or MIMS. The device was inspired by the glaucoma treatment challenge issued by Sir Peng Khaw, MD, PhD, Moorfields Eye Hospital, London, a 10-minute technique that will reduce IOP to 10 mm Hg for at least 10 years.

    More: Techniques for treating narrow angle glaucoma

    “I call this the 103 challenge and it has been our vision,” said Chief Executive Officer Nir Israeli. “MIMS creates a scleral corneal channel to drain aqueous into the subconjunctival space. It is safe, efficient, and easy to perform. We hope it will become the standard procedure for treating glaucoma and combined glaucoma-cataract surgery.”

    The handheld device is essentially a small drill that is inserted through the conjunctiva about 10 mm from the limbus and through the scleral corneal junction. Once in place, it rotates for 5 seconds to create a 50-µm channel to drain aqueous. The entire procedure takes less than 2 minutes.

    Detecting glaucoma: How Ceeable aims to be the next gold standard in visual fields

    First in-human studies with 23 procedures in 19 patients provided promising results, Israeli said. Patients showed clinically significant drops in IOP, typically from the 20 to 40 mm Hg range down to 10 to 16 mm Hg at 3 and 6 months. The channels remained stable for at least 6 months.

    “Our competitors are all using implants and some of them require complex operations,” he added. “MIMS is different. It is an efficient, 2-minute surgery that suits the vast majority of glaucoma patients. We believe it will last for many years.”

    The company expects to get its CE mark later in 2016 and launch European sales by mid-2017. The U.S. timeline is longer, with an IDE expected in early 2017, pivotal studies in 2019 and approval later that year.

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