title: The use of poly(styrene-block-isobutylene-block-styrene) as a microshunt to treat glaucoma.
abstract: The InnFocus MicroShunt® is a minimally invasive glaucoma drainage microtube used to shunt aqueous humor from the anterior chamber of the eye to a flap formed under the conjunctiva and Tenon's capsule. The safety and clinical performance of this device approaches that of trabeculectomy with mitomycin C, the current 'gold standard' treatment for advanced glaucoma. The invention of a new biomaterial called poly(styrene-block-isobutylene-block-styrene) or 'SIBS' is the enabling factor which led to the success of this product. SIBS is ultrastable with virtually no foreign body reaction in the body, which manifests as clinically insignificant inflammation and capsule formation in the eye. The lack of capsule formation enables unobstructed flow through the 70 µm lumen tube and the achievement of controlled low intraocular pressure, which is important for the management of glaucoma. This article summarizes the integration of SIBS into a glaucoma drainage device and confirms its functionality with clinical success over a 2-year period.
authors.affiliation: InnFocus, Inc., Miami, FL, USA;; Ophthalmic Biophysics Center, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, FL, USA;
authors.forename: Leonard
authors.initials: L
authors.lastname: Pinchuk
authors.affiliation: Pôle Ophtalmologique De La Clinique Mutualiste, Pessac Cedex, France;
authors.forename: Isabelle
authors.initials: I
authors.lastname: Riss
authors.affiliation: Centro Laser, Santo Domingo, Dominican Republic;
authors.forename: Juan F
authors.initials: JF
authors.lastname: Batlle
authors.affiliation: InnFocus, Inc., Miami, FL, USA;
authors.forename: Yasushi P
authors.initials: YP
authors.lastname: Kato
authors.affiliation: InnFocus, Inc., Miami, FL, USA;
authors.forename: John B
authors.initials: JB
authors.lastname: Martin
authors.affiliation: Ophthalmic Biophysics Center, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, FL, USA;
authors.forename: Esdras
authors.initials: E
authors.lastname: Arrieta
authors.affiliation: Anne Bates Leach Eye Hospital, University of Miami, Bascom Palmer Eye Institute, Miller School of Medicine, Miami, FL, USA and.
authors.forename: Paul
authors.initials: P
authors.lastname: Palmberg
authors.affiliation: Anne Bates Leach Eye Hospital, University of Miami, Bascom Palmer Eye Institute, Miller School of Medicine, Miami, FL, USA and.
authors.forename: Richard K
authors.initials: RK
authors.lastname: Parrish
authors.affiliation: InnFocus, Inc., Miami, FL, USA;
authors.forename: Bruce A
authors.initials: BA
authors.lastname: Weber
authors.affiliation: InnFocus, Inc., Miami, FL, USA;
authors.forename: Yongmoon
authors.initials: Y
authors.lastname: Kwon
authors.affiliation: Ophthalmic Biophysics Center, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, FL, USA;; Department of Ophthalmology, University of Paris Hotel-Dieu Hospital, Paris, France.
authors.forename: Jean-Marie
authors.initials: JM
authors.lastname: Parel
keywords: biocompatibility; medical device; soft tissue; stent