Medtronic (NYSE:MDT) said today it launched a long-term clinical study of its Infuse bone graft for use during posterolateral fusion and transforaminal lumbar interbody fusion spine procedures. The 1st patient in the study was enrolled at Indiana’s Fort Wayne Orthopedics and underwent a procedure led by Dr. Kevin Rahn and Dr. Robert Shugart, Fridley, Minn.-based Medtronic […]
Clinical Trials
Apollo Endosurgery touts 20-year Lap-Band data
Apollo Endosurgery today released 20-year outcomes data from its Lap-Band system, touting it as a safe and effective procedure which results in sustained, medically relevant weight loss. Outcomes data was presented at the 22nd World Congress of the International Federation for the Surgery of Obesity and Metabolic Disorders in London. Data came from follow-ups with 8,263 […]
LabCorp completes $1.2B Chiltern buy
Diagnostics company LabCorp (NYSE:LH) said today that it has closed its $1.2 billion acquisition of contract research organization Chiltern International. Chiltern is slated to fold into the company’s Covance drug development business, which conducts clinical trials for drugmakers. Get the full story at our sister site, Drug Delivery Business News.
Ethicon touts progress on multi-year bariatric surgery evidence initiative
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon said today it has made major progress in its “Project Game Changer” initiative which looks to close evidence gaps and reduce clinical and economic barriers for access to surgical treatments for treating obesity and related diseases. With the Game Changer Initiative, the company said it is focusing its research and evidence […]
Abbott launches Amplatzer newborn congenital heart defect trial
Abbott (NYSE:ABT) said today it launched a US pivotal trial looking to explore the safety and effectiveness of a modified version of its Amplatzer device designed to correct patent ductus arteriosus, a congenital heart defect in pre-term infants. “Patent ductus arteriosus is one of the most common heart defects, accounting for 5% to 10% of all […]
Vascular Dynamics touts significant BP reductions in interim MobiusHD trial results
Vascular Dynamics yesterday released interim results from the 1st-in-human trial of its MobiusHD implant designed for treating resistant hypertension, touting significant reductions in ambulatory systolic blood pressure. Results were released at the European Society of Cardiology’s annual meeting in Barcelona. The MobiusHD device is designed to help regulate blood pressure using electrodes implanted in the carotid […]
InVivo retools to get Inspire trial back on track, lays off 39%
InVivo Therapeutics (NSDQ:NVIV) said yesterday that it’s laying off nearly 40% of its workforce, pausing a clinical trial and cutting two R&D programs as it tries to get its a pivotal study back on track. The Cambridge, Mass.-based company, which is developing a scaffold implant to treat traumatic spinal cord injuries, last month suspended its 16-patient […]
ESC 2017 Roundup: Biotronik touts lowered mortality for AF patients treated with cath ablation
Biotronik today released results from the Castle-AF study exploring the use of catheter ablation to treat heart failure patients with atrial fibrillation, touting a 38% composite reduction in all-cause mortality and hospitalization for worsening heart failure. The 398-patient, 33-site study compared the results of catheter ablation treatment for AF in heart failure patients using implantable cardioverter […]
Biotronik’s Orsiro drug-eluting stent tops Abbott’s Xience in study
Biotronik said today that its Orsiro drug-eluting stent beat Abbott‘s (NYSE:ABT) Xience DES in a trial comparing the target lesion failure rates of both devices. The data, which were presented at the European Society of Cardiology’s ESC Congress and published by The Lancet, showed a 6.2% TLF rate at 12-months for patients treated with Orsiro compared to 9.6% […]
FDA clears Second Sight IDE trial of next-gen Orion cortical visual prosthesis
Second Sight Medical (NSDQ:EYES) said today it won FDA investigational device exemption to initiate a feasibility clinical study of its Orion cortical visual prosthesis system. The conditional approval gives the Sylmar, Calif.-based company clearance to enroll up to 5 patients at 2 US sites, but requires that the company conduct additional device testing and “address outstanding […]
Xarelto, aspirin combo reduces risk of cardiovascular events in pivotal Ph3 trial
Johnson & Johnson (NYSE:JNJ) subsidiary Janssen touted data today from a pivotal Phase III trial showing that Xarelto plus aspirin reduced the risk of major cardiovascular events in patients with stable coronary and peripheral artery disease compared to aspirin alone. Treatment with Xarelto twice per day and aspirin once-daily cut the risk of major cardiovascular events […]