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 […]
Clinical Trials
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 […]
GE Healthcare, NBA name research award winners
GE Healthcare (NYSE:GE) and the National Basketball Association today announced the 1st round of winning research proposals submitted to their Sports Medicine and Orthopedic collaboration, which was launched last year. The joined Sports Medicine and Orthopedic strategic collaboration aims to fund research to address prevention, diagnosis and treatment of musculoskeletal injuries affecting NBA players and everyday […]
ForSight Vision5’s Helios implant delivers at 6 months in Phase II trial
The Helios drug-eluting implant developed by ForSight Vision5 lowered intraocular pressure in glaucoma patients by about 20% after 6 months, according to study results published today in Ophthalmology, the journal of the American Academy of Ophthalmology. The Helios device is a thin, silicone ring impregnated with the glaucoma drug bimatoprost that’s designed to slowly release the drug […]
Medtronic touts 7-year follow-up data on 2-level Prestige LP disc
Medtronic (NYSE:MDT) today released 7-year follow-up data from a study of its 2-level Prestige LP cervical disc, touting favorable clinical outcomes and patient satisfaction with the system. Medtronic touts the study as the longest patient follow-up data ever for U.S. 2-level cervical disc patients. The data was presented at the 84th Annual Meeting of the American […]