Allergan (NYSE:AGN) said today that it’s on track for an FDA submission this year for the Oculeve nasal neurostimulation device for dry eye it bought last year. Oculeve is a hand-held device designed to be inserted into the nostril to stimulate the nerves serving the lacrimal gland. Allergan paid $125 million plus unspecified milestones for Oculeve last year. Today the […]
Clinical Trials
Impulse Dynamics raises $30m for Optimizer IVs implantable heart failure device
Impulse Dynamics said last week that it raised $30 million for its Optimizer IVs implantable heart failure device, led by the Hong Kong investment fund of real estate developer Peter Lee Ka Kit. Stuttgart, Germany-based Impulse said it plans to use the proceeds to expand its commercial footprint for the device, which 1st won CE Mark approval in the […]
Humacyte launches pivotal trial for lab-grown blood vessel
Humacyte is launching a Phase III study of its lab-grown blood vessel Humacyl in 350 patients with end-stage renal disease who are on hemodialysis and don’t qualify for a standard surgical treatment, and Boston’s Brigham & Women’s Hospital plans to take part. Plans to move ahead to Phase III follow a promising Phase II clinical study […]
Corvia Medical lands CE Mark for heart shunt
Corvia Medical said today that it landed CE Mark approval in the European Union for its InterAtrial Shunt device for treating a type of heart failure. The IASD is designed to lower blood pressure in the left atrium and lungs by creating a small opening between the left and right atria. It’s indicated for diastolic heart […]
InVivo adds 20th clinical site to Inspire study
InVivo Therapeutics (NSDQ:NVIV) said today it added Philadelphia’s Hospital of the University of Pennsylvania as a site in the Inspire study of its neuro-spinal scaffold, bringing the total number of sites up to 20. The Cambridge, Mass.-based company’s neuro-spinal scaffold is surgically implanted following acute spinal cord injuries to act as a physical substrate for nerve […]
Biotronik launches Orsiro drug-eluting stent trial
Biotronik said today it enrolled the 1st patient in its BiostemI trial looking to compare the safety and efficacy of its Orsiro hybrid drug-eluting stent with Abbott‘s (NYSE:ABT) Xience Xpedition in treating ST-segment elevation myocardial infarction. The company is touting the trial as the largest investigator-initiated study pitting the Orsiro stent against the Xience Xpedition. The randomized, […]
NeoTract touts 4-year UroLift data
NeoTract today released the results from 2 randomized studies of its UroLift system designed to treat benign prostatic hyperplasia, touting “excellent” durability after 4 years. The data was presented at the American Urological Association’s 2016 annual meeting in San Diego this week. “The clinical data presented at this year’s AUA conference show that treatment with the […]
GI Dynamics touts new safety, efficacy data for EndoBarrier
GI Dynamics (ASX:GID) today touted new safety and efficacy data on its EndoBarrier device designed for weight loss, claiming meaningful improvements in hemoglobin A1c levels and weight reduction in study participants. The trial avoided previous issues involving liver abscesses that forced the halt of a U.S. clinical trial for the EndoBarrier device in July last year. […]
Abbott’s Tecnis Symfony intraocular lens clears pivotal trial
Abbott (NYSE:ABT) said today its Tecnis Symfony 1-piece acrylic intraocular lens met its primary endpoint in the pivotal trial of the device designed for cataract surgery. Data from the trial indicated that people who were implanted with the lens demonstrated improved intermediate and near vision compared to those who received a monofocal intraocular lens, the company […]
HRS 2016 roundup: Leadless pacers at the fore
Medtronic (NYSE:MDT) and St. Jude Medical (NYSE:STJ), aiming to distinguish their respective leadless pacemaker offerings, presented new data last week in San Francisco at the Heart Rhythm Society’s annual meeting. St. Jude said a subset of data from the Leadless II trial showed that its Nanostim device was was successfully retrieved in 14 patients up to 3.2 years after implantation, […]
Intarcia raises another $75m, touts top-line safety data in pivotal trial
Intarcia Therapeutics said today that it raised another $75 million in a debt financing round and touted the top-line cardiovascular safety data from the final phase in its clinical program for its ITCA 650 implantable drug pump for Type II diabetics. Boston-based Intarcia said it plans to begin filing for U.S. approval from the FDA during the 3rd […]