Miami, FL, United States
Miami, FL, United States

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PubMed | Anne Bates Leach Eye Hospital, InnFocus Inc, Pole Ophtalmologique de la Clinique Mutualiste, Centro Laser and University of Miami
Type: Review | Journal: Journal of biomedical materials research. Part B, Applied biomaterials | Year: 2015

Glaucoma is the second leading cause of blindness with 70 million people worldwide who are blind from this disease. The currently practiced trabeculectomy surgery, the gold standard treatment used to stop the progression of vision loss, is rather draconian, traumatic to the patient and requires much surgical skill to perform. This article summarizes the more than 10-year development path of a novel device called the InnFocus MicroShunt, which is a minimally invasive glaucoma drainage micro-tube used to shunt aqueous humor from the anterior chamber of the eye to a flap formed under the conjunctiva and Tenons Capsule. The safety and clinical performance of this device approaches that of trabeculectomy. The impetus to develop this device stemmed from the invention of a new biomaterial called poly(styrene-block-isobutylene-block-styrene), or SIBS. SIBS is ultra-stable with virtually no foreign body reaction in the body, which manifests in the eye as clinically insignificant inflammation and capsule formation. The quest for an easier, safer, and more effective method of treating glaucoma led to the marriage of SIBS with this glaucoma drainage micro-tube. This article summarizes the development of SIBS and the subsequent three iterations of design and four clinical trials that drove the one-year qualified success rate of the device from 43% to 100%. 2015 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 105B: 211-221, 2017.


Trademark
InnFocus Inc and Innfocus Llc | Date: 2013-02-19

Ophthalmic Medical Devices, namely, glaucoma tube shunts.


PubMed | InnFocus Inc, Centro Laser, Pole ophtalmologique and University of Miami
Type: Comparative Study | Journal: Journal francais d'ophtalmologie | Year: 2015

To compare intraocular pressure (IOP) at one year with the InnFocus MicroShunt() with or without cataract surgery with according to placement and concentration of mitomycin C (MMC) DESIGN: A retrospective two-center, two-surgeon study (France and Dominican Republic).Adults with POAG requiring filtering surgery. One MicroShunt() was placed in one eye of each patient. The effect of concentration and site of application of MMC was assessed by IOP and medication reduction at one year.Eighty-seven eyes were studied with one-year follow-up. Twenty-three eyes treated with 0.4 mg/mL MMC close to the limbus demonstrated a 55% reduction in IOP from 23.8 5.3 at baseline to 10.7 2.8 mmHg at one year. Topical glaucoma medication/patient was reduced 85% from 2.4 0.9 to 0.3 0.8. Thirty-one eyes treated with 0.2mg/mL MMC close to the limbus demonstrated a 52% reduction in IOP from 27.9 6.7 at baseline to 13.3 3.3 mmHg at one year. Topical glaucoma medication/patient was reduced 88% from 2.5 1.4 to 0.5 1.0. Thirty-three eyes treated with 0.4 mg/mL MMC deep in the pocket demonstrated a 38% reduction in IOP from 25.4 7.9 at baseline to 15.7 4.6 mmHg at one year. Topical glaucoma medication/patient was reduced 72% from 2.9 1.0 to 0.8 1.3. There were no sight-threatening long-term adverse events.The InnFocus MicroShunt() is a filtering surgery whose efficacy is related to the location of application and concentration of MMC used.


Patent
InnFocus Inc | Date: 2015-06-01

A system is provided including an elongate needle body and an aqueous humor drainage device. The drainage device includes an elongated tube that is operatively coupled to a proximal end of the needle body. Methods for the implantation of the aqueous humor drainage device in the eye are provided. A system including an elongate needle body and drainage device is also provided for draining other body cavities.


A method for treating glaucoma with an implantable glaucoma device includes inserting a hollow elongated needle into the eye between the cornea and iris and into the anterior chamber of the eye to form a needle tract in the eye, introducing a distal end of a guidewire through the needle and into the anterior chamber, introducing a snare through a corneal incision into the anterior chamber. The snare has a sheath and a hook or loop inside the sheath and extendible therefrom. The method includes capturing a segment of the guidewire proximate the distal end of the guidewire with the snare within the anterior chamber, removing the needle from over the guidewire outside of the eye, coupling a glaucoma drainage device to a proximal end of the guidewire that extends outside of the eye, and pulling on the captured guidewire segment with the snare to pull the glaucoma drainage device into the needle tract and into the anterior chamber of the eye until the glaucoma device is located in an implanted position in the eye. The method can also possibly involve removing the snare from the eye, cutting a distal end of the glaucoma device (possibly within the anterior chamber), and removing the cut distal end of the glaucoma drainage device from the eye. An improved glaucoma drainage device and other deployment systems and methods are also described and claimed.


Patent
InnFocus Inc | Date: 2014-06-09

An inserter is provided for inserting a tubular medical implant device into tissue. The inserter includes a rigid rod extending along a longitudinal axis. The rod has a distal portion that defines an open slot. The open slot extends diametrically through the rod along the longitudinal axis to a base. The open slot is configured to receive and release the tubular medical implant device.


Patent
InnFocus Inc | Date: 2015-07-31

A surgical kit includes at least one instrument and at least one implant device. The instrument has a needle body used to form a surgical passage through ocular tissue. The device includes a flexible tube that defines a duct for diverting aqueous humor with an outer surface having a maximal cross-sectional dimension that is less than the maximal cross-sectional dimension of the needle body. The device incorporates a seal that defines a maximal cross-sectional dimension that is greater that the maximal cross-sectional dimension of the needle body and is operably disposed within the surgical passage and forms a seal between the surrounding ocular tissue. The kit (and devices thereof) can be used as part of a surgical method to divert aqueous humor to a space formed in ocular tissue.


Patent
InnFocus Inc | Date: 2014-10-10

A system is provided including an elongate needle body and an aqueous humor drainage device. The drainage device includes an elongated flexible tube that is operatively coupled to a proximal end of the needle body. Methods for the implantation of the aqueous humor drainage device in the eye are provided. A system including an elongate needle body and drainage device is also provided for draining other body cavities.


Trademark
InnFocus Inc | Date: 2014-07-30

Ophthalmic medical devices, namely, glaucoma tube shunts.


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