Royal Philips (NYSE:PHG) and ResMed (NYSE:RMD) today touted results from a collaboratively-supported clinical trial exploring the use of home noninvasive ventilation with oxygen therapy on patients with chronic obstructive pulmonary disorder, which indicated improved survivability and prolonged time to readmission. Results from the study were published today in the Journal of the American Medical Association. “Patients […]
Clinical Trials
EuroPCR Roundup: Bioresorbable stents show promise, but metallic drug-eluting stents remain standard
Abbott’s (NYSE:ABT) bioresorbable scaffold has been plagued with a myriad of troubling data, including a study that showed that the device is associated with an increase in thrombosis and target lesion failure. In April, Abbott pulled the stent from European markets. In response to widespread criticism of the technology, the EuroPCR team released a statement this […]
ViaCyte looks to cell replacement therapy to cure Type I diabetes
ViaCyte said today that it will begin clinical trials of its novel islet cell replacement therapy in development as a potential cure for Type I diabetes, after landing regulatory wins from the FDA and Health Canada. The company’s PEC-Direct candidate delivers stem cell-derived pancreatic progenitor cells in a device that is designed to enable direct […]
BTG touts Ekos data from pulmonary embolism trial
BTG (LON:BTG) touted data today from the Optalyse PE trial showing that pulmonary embolism can be treated effectively with Ekos over a shorter period and with smaller doses of thrombolytic drugs compared to the current standard. The 101-patient trial randomized participants to receive therapeutic anticoagulation and Ekos acoustic pulse thrombolysis therapy at different doses for different lengths […]
BoneSupport launches trial of antibiotic-eluting bone graft
BoneSupport said today that the 1st patient has been enrolled in the pivotal investigational device exemption trial for its injectable antibiotic-eluting bone graft substitute. The company’s Fortify trial plans to evaluate Cerament G’s ability to improve the traditional management of patients with open factures of the tibial diaphysis. The trial is slated to enroll up […]
7 medtech stories we missed this week: May 19, 2017
From FDA clearances to touting study data, here are 7 medtech stories we missed this week but thought were still worth mentioning. 1. XpandOrtho wins FDA 510(k) clearance XpandOrtho announced in a May 17 press release that it has received FDA 510(k) clearance for its electronic soft tissue balancing instrument for total knee replacement surgery. […]
Slow enrollment delays Nexstim pivotal trial
Nexstim said today that slow enrollment in pivotal trial of its Navigated Brain Therapy transcranial magnetic stimulation device in treating patients rehabilitating from stroke. The 60-patient E-Fit study, launched in March, is designed to supplement Nexstim’s already complete Niche study. The Finnish company originally expected to conclude the E-Fit supplemental during the 1st quarter next year, but said […]
Sirtex SIR-Spheres fail to improve survival in colorectal trial
Sirtex Medical (ASX:SRX) saw shares tumble more than 25% today after a trial of its radioactive microspheres reported no effect in improving survival in patients with colorectal cancer. Results from the Foxfire analysis study indicated that the use of SIR-Spheres Y-90 microspheres in combination with chemotherapy did not improve overall survival in patients with unresectable colorectal […]
Nemaura touts data for Memspatch insulin micro-needle device
Nemaura Pharma‘s Memspatch insulin micro-needle device compared well against a pen injector in an 18-patient clinical trials, according to the company. The group of Type I diabetic patients were given insulin using either the Memspatch device or a traditional pen injector. Researchers evaluated the patient’s pain levels using a number pain rating score from 0 […]
Avita ReCell pivotal meets endpoints, shares jump
Avita Medical (ASX:AVH) saw shares rise over 5% today after announcing that the pivotal clinical trial of its regenerative ReCell device for treating severe burns met both co-primary endpoints. The ReCell device is designed to use the patient’s own skin cells to treat a variety of skin issues, including burns, reconstructive and cosmetic procedures, the Cambridge, U.K.-based […]
Rotation Medical release initial results for ‘bioinductive’ shoulder implant
Rotation Medical touted initial data today from the Rebuild registry of its bioinductive implant at the annual meeting of the Arthroscopy Association of North America. Interim results from the 1st 200 patients demonstrated significantly less post-operative pain and use of narcotics in patients who received the bioinductive implant, as well as less sling time, faster […]