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 […]
Clinical Trials
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 […]
EuroPCR Roundup: Medtronic’s Resolute Onyx meets primary endpoint in small-vessel trial
Medtronic‘s (NYSE:MDT) Resolute Onyx 2.0mm drug-eluting stent met its primary endpoint of target lesion failure at 1 year for the treatment of coronary artery disease in extra-small vessels, according to data from the Resolute Onyx 2.0mm trial. The trial enrolled 101 patients with extra-small vessel sizes ranging from 2 millimeters to 2.25 millimeters. Patients treated with […]
ESOC 2017 Roundup: Gore touts lowered ischemic stroke, new brain infarcts in PFO Occluder test
W.L. Gore & Associates yesterday released results from the Reduce study of its Cardioform Septal Occluder devices used to close patent foramen ovale, touting a reduction in recurrent ischemic strokes and new brain infarcts. The Gore Cardioform Septal Occluder is designed to be inserted via catheter and is currently cleared by the FDA for closure […]
Xeltis touts preclinical bioresorbable heart valve data
Xeltis today released early data on its bioresorbable heart valves built on endogenous tissue restoration technology, touting potential benefits of the regenerative approach to heart valve replacement. The Swiss medical device company’s technology is designed to promote endogenous tissue restoration using polymers structured as a resorbable “porous matrix.” The aim is to gradually replace the polymer […]