iSTAR Medical announced today that the FDA granted investigational device exemption to start a pivotal trial with its MINIject implant. Wavre, Belgium–based iStar’s MINIject minimally invasive implant for glaucoma surgery will be investigated in the STAR-V study, enrolling over 350 patients with primary open-angle glaucoma. MINIject combines the porous structure of iSTAR’s proprietary STAR material […]
Implants
Nanoform, Celanese partner to develop nanoparticle-enabled drug delivery
Nanoform announced today that it partnered with Celanese to explore the use of their technologies in nanoparticle-enabled drug delivery. Helsinki-based Nanoform said the goal of the collaboration is to assess the combination of its nanoparticle platform technologies with Celanese’s VitalDose EVA copolymer delivery technology for drug-eluting implants, according to a news release. Both companies intend […]
Intersect ENT wins CE mark for Propel Contour sinus implant
Intersect ENT (NSDQ:XENT) announced today that it received CE mark approval for its Propel Contour sinus implant. Menlo Park, Calif.-based Intersect ENT designed its Propel Contour sinus implant to maintain patency and reduce inflammation while conforming to the sinus ostia (openings) through mechanical support and steroid delivery where needed to optimize sinus surgery outcomes. Get the […]
Innocoll Biotherapeutics initiates Phase 3 trials for collagen drug-device
Innocoll Biotherapeutics announced today that it initiated two Phase 3 trials to support a label expansion for its collagen drug-device implant. Athlone, Ireland-based Innocoll’s trials are seeking label expansion for the FDA-approved Xaracoll (bupivacaine hydrochloride) implant, according to a news release. INN-CB-024, a Phase 3, randomized, double-blind, placebo-controlled study is evaluating the efficacy and safety […]
Merck moving to Phase 2 study of drug-eluting implant to prevent HIV infection
Merck (NYSE:MRK) today announced positive results from a Phase 1 study of its subdermal drug-eluting implant for preventing HIV-1 infection. The investigational implant has the potential for extended administration of islatravir for pre-exposure prophylaxis (PrEP) of HIV-1 infection, according to a news release. Islatravir is an investigational nucleoside reverse transcriptase translocation inhibitor (NRTTI) being valuated […]
CMS consolidates coverage for Intersect ENT’s corticosteroid-eluting implant
Intersect ENT (NSDQ:XENT) announced today that it received consolidated Medicare coverage for its Sinuva sinus implant. Menlo Park, Calif.-based Intersect ENT said in a news release that CMS published an average selling price (ASP) for the Sinuva implant, providing predictability, transparency and confidence of reimbursement for providers and payers in the future. Sinuva is a […]
Abbott touts Xience DES study results
A pair of studies of Abbott’s Xience drug-eluting stent showed no difference between shorter courses of treatment with dual antiplatelet therapy (DAPT) compared with 12 months of DAPT following implantation of the XIENCE drug-eluting stent (DES) in patients who are at a high risk of bleeding. Abbott presented the late-breaking data today at TCT Connect, the […]
FDA approves BioStage’s esophageal device investigational new drug application
Biostage (NSDQ:BSTG) this week announced that its Cellspan Esophageal Implant investigational new drug application won FDA approval. The Cellspan Esophageal Implant is designed to treat patients with end-stage esophageal disease that require segmental surgical resection to repair diseased tissue. Biostage announced the first patient was treated with the esophageal implant in August 2017. The device was […]
Indiana man may proceed with pain pump lawsuit against Medtronic
An Indiana federal judge on Friday dismissed two parts of a lawsuit against Medtronic (NYSE:MDT), but said that the plaintiff can continue to pursue the third count. Kirk Bledsoe sued Medtronic in Indiana state court in 2017 after the company’s Synchromed II pain pump, which Bledsoe had implanted in 2011, failed on two occasions and […]
Intarcia Therapeutics takes another run at FDA approval
Intarcia Therapeutics said last week that the FDA accepted its new drug application resubmission for ITCA 650 for the treatment of Type 2 diabetes mellitus. The Boston-based company originally resubmitted the NDA on Sept. 9. FDA told the company that it considered the NDA resubmission a complete class 2 response. The Prescription Drug User Fee […]
