A purported class action lawsuit accuses a Johnson & Johnson (NYSE:JNJ) subsidiary, a California hospital and an orthopedic surgeon of conducting unauthorized clinical trials without patients’ consent and alleges that the lead plaintiff was implanted with a group of unapproved hip implant components. The June 17 lawsuit, filed in the U.S. District Court for Northern California, […]
Clinical Trials
NIH Researchers design placenta-on-a-chip to study pregnancy
The National Institutes of Health said today that researchers have developed a novel “placenta-on-a-chip” to study the human placenta and its role in pregnancy. The device is designed to imitate the structure and function of human placenta and model nutrient transfer on a micro-level, the NIH said in a news release. “We believe that this technology may […]
TAVI: Boston Scientific’s Lotus valve tops Medtronic’s CoreValve – study
Data from a study of Boston Scientific‘s (NYSE:BSX) Lotus Valve showed a greater device success rate than Medtronic‘s (NYSE:MDT) CoreValve in high-risk transcatheter aortic valve replacement patients. The single-center, non-randomized study, published this month in the journal JACC: Cardiovascular Interventions, compared outcomes from 50 high-risk TAVI patients treated with the Lotus valve and 50 similar patients treated with Medtronic’s self-expanding CoreValve […]
New Watchman study reports positive data
New data from a study of Boston Scientific (NYSE:BSX)’s Watchman left atrial appendage closure device reports positive results in a study comparing it to warfarin, an anticoagulant drug treatment, in patients with nonvalvular atrial fibrillation. The 2,406-patient study, published in the Journal of the American College of Cardiology, reported a lower rate of hemorrhagic strokes, unexplained and cardiovascular […]
Diabetes: Medtronic furthers the quest for an artificial pancreas
Medtronic (NYSE:MDT) and Intarcia Therapeutics were in the spotlight at the American Diabetes Assn.’s annual scientific sessions conference in Boston last week, revealing new medical device developments in the fight against diabetes. Medtronic took center stage, announcing new developments for its artificial pancreas program, touting positive data from a user study of its MiniMed 640g and revealing plans to collaborate […]
IsoRay faces lawsuits alleging fudged clinical data
IsoRay (NYSE:ISR) is facing putative class-action lawsuits from shareholders accusing the company of making false or misleading statements about a clinical trial of its Cesium 131 brachytherapy seeds designed to treat cancer. The lawsuits, from at least 3 different shareholders, claim that IsoRay made false statements about a clinical study of Cesium 131. The study was the 1st […]
Augmenix touts publication of pivotal SpaceOar study
Augmenix said last week that a pivotal study of its SpaceOar system was published online in the International Journal of Radiation Oncology•Biology•Physics. The 222-patient pivotal study was designed to evaluate safety and efficacy of the SpaceOar System in men undergoing prostate radiotherapy, the company said. The SpaceOar is designed to separate the prostate from the rectal wall during radiation […]
St. Jude Medical touts early results for Axium neurostim device
St. Jude Medical (NYSE:STJ) said Monday that a study of its Axium dorsal root ganglion neurostimulator showed superior pain relief compared to traditional spinal cord stimulation in treating chronic lower limb pain associated with complex regional pain syndrome. The the 152-patient Accurate study reported that 81.2% of patients treated with the Axium system achieved significant pain […]
Stimwave wins nod from FDA for IDE trial
Stimwave Technologies said yesterday it won FDA investigational device exemption clearance to test an 8-electrode version of its wireless miniature neurostimulator device for the relief of chronic back and leg pain. Miami, Fl.-based Stimwave said the FDA also approved a study of the device using high frequency treatments through an external pulse generator. “This study […]
TAVI: St. Jude Medical can resume Portico trial
St. Jude Medical (NYSE:STJ), which paused implantations of its Portico replacement heart valve last fall out of an abundance of caution, won the FDA’s approval to resume U.S. implants of the device in a clinical trial, the company said yesterday. Back in September 2014, St. Jude said CT scans turned up a potential problem with the Portico valves in […]
Positive early data for Valtech’s Cardioband
A trial of Valtech Cardio‘s Cardioband transcatheter annuloplasty system showed no device-related mortality, with decreases in mitral regurgitation and septo-lateral dimension. Results from the 40-patient multicenter observational study, designed to evaluate the safety and performance of the Cardioband, were presented this week at the European Society of Cardiology’s annual meeting in Paris. The study was […]
