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Implants

Intersect ENT wins CE mark for Propel Contour sinus implant

May 20, 2021 By Sean Whooley

Intersect ENT updated

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 […]

Filed Under: Drug-Device Combinations, Featured, Implants, Otolaryngology Ear, Nose & Throat, Regulatory/Compliance Tagged With: Intersect ENT Inc.

Innocoll Biotherapeutics initiates Phase 3 trials for collagen drug-device

April 14, 2021 By Sean Whooley

Innocoll

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 […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Implants, Surgical Tagged With: innocoll

Merck moving to Phase 2 study of drug-eluting implant to prevent HIV infection

March 8, 2021 By Sean Whooley

Merck

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 […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Implants, Pharmaceuticals Tagged With: HIV, Merck

CMS consolidates coverage for Intersect ENT’s corticosteroid-eluting implant

March 8, 2021 By Sean Whooley

Intersect ENT updated

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 […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Implants, Otolaryngology Ear, Nose & Throat Tagged With: Centers for Medicare and Medicaid Services (CMS), Intersect ENT Inc.

Abbott touts Xience DES study results

October 15, 2020 By Nancy Crotti

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 […]

Filed Under: Cardiovascular, Clinical Trials, Drug-Device Combinations, Featured, Implants, Stents Tagged With: abbott, TCT 2020

FDA approves BioStage’s esophageal device investigational new drug application

March 25, 2020 By Danielle Kirsh

Biostage prices $8m offering for bioengineered organ implants

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 […]

Filed Under: Food & Drug Administration (FDA), Implants, Regulatory/Compliance Tagged With: Biostage

Indiana man may proceed with pain pump lawsuit against Medtronic

January 6, 2020 By Nancy Crotti

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 […]

Filed Under: Featured, Implants, Legal News, Pain Management Tagged With: Medtronic

Intarcia Therapeutics takes another run at FDA approval

October 15, 2019 By Sean Whooley

Intarcia Therapeutics

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 […]

Filed Under: Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Implants Tagged With: FDA, Intarcia Therapeutics

Ocular Therapeutix doses first patients in pivotal allergic conjunctivitis trial of Dextenza

September 25, 2019 By Danielle Kirsh

Ocular Therapeutix logo

Ocular Therapeutix (NSDQ:OCUL) yesterday said it dosed the first patients in a Phase 3 clinical trial of its Dextenza drug-device combination. The U.S.-based Phase 3 clinical trial is a multi-center, 1:1 randomized, double-masked, placebo-controlled trial slated to enroll 80 patients. The study will evaluate Dextenza 0.4mg to treat allergic conjunctivitis and ocular itching versus a placebo […]

Filed Under: Drug-Device Combinations, Implants, Optical/Ophthalmic Tagged With: Ocular Therapeutix

Senseonics touts long-term safety data on home-use Eversense

August 28, 2019 By Sean Whooley

Senseonics - updated logo

Senseonics (NYSE:SENS) yesterday touted real-world data it said demonstrated the safety and lack of adverse events with its Eversense continuous glucose monitoring system for people with diabetes. Eversense is a long-term, implantable GCM sensor with a transmitter that sends discreet vibrations to alert users of low or high glucose. The device can be removed, recharged and […]

Filed Under: Diabetes, Featured, Implants Tagged With: Senseonics

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