The federal Patient-Centered Outcomes Research Institute added three medical device-related topics to its list of priority research areas that are eligible for enhanced funding under the Pragmatic Clinical Studies initiative. In the new funding round, comparative trials studying cardiology, hip fracture and surgical mesh are invited to apply.
Researchers have developed a device that could determine how soon patients should be fed following surgery. Patients with the intestinal problem postoperative ileus fall sick if they eat too soon after surgery and must stay in the hospital for an additional two to three days.
Celladon has announced the beginning of a trial it hopes will determine the feasibility of using MYDICAR in heart failure patients using left ventricular assist devices.
An employment report released today by EP Vantage found that 12 of the 15 biggest device companies added to their head count in 2013. And Abbott and Covidien would have been net hirers were it not for the divestment of their pharma arms that year--resulting in the transfer of jobs to other companies, leaving Boston Scientific as the only large company to truly eliminate jobs last year.
The FDA's Gastroenterology & Urology Devices panel came down firmly against EDAP's Ablatherm system for treating low-risk, localized prostate cancer. The panel voted 9-0 on the device's effectiveness, 5-3 against its safety (with one abstention) and said the risks outweigh the benefits by a vote of 8-0 (with one abstention).
Complications of diabetes are more easily treated when they are found early. Researchers at National Taiwan University Hospital have developed a wearable optical device to detect diabetic autonomic neuropathy, a common diabetic complication, that could be better than existing detection methods.
Data from a European postmarket registry show that Abbott's Absorb BVS bioresorbable stent performs at a level similar to today's conventional drug-eluting stents on several measures, but not stent thrombosis. The risk of the stent being blocked by a blood clot was 3.4% after one year, a level of performance similar to prior generation drug-eluting stents, according to a recent EuroIntervention study.
Intuitve Surgical had to defend its robotic surgery platform again, this time from a study which reports that insurance claims data shows that bladder cancer patients had a similar complication rate and length of hospital stay regardless of whether their bladder was removed robotically or in a more invasive open procedure.
Amid growing safety concerns over the use of power morcellator tools in gynecological procedures, new research shows that a significant number of women undergoing laparoscopic surgery with the device have increased levels of undetected cancer.
Catheter-directed thrombolysis (CDT) has been used in an effort to reduce the incidence of post-thrombotic syndrome in deep vein thrombosis. But a newly published observational study suggests that not only is catheter use ineffective at preventing post-thrombotic syndrome, but it is actually associated with higher rates of adverse events.