Medtronic (NYSE:MDT) said today that it launched a huge, real-world study of the SuperDimension lung device it acquired along with Covidien earlier this year. The 2-year, 2,500-patient Navigate trial is designed to evaluate the performance of the LungGPS electromagnetic navigation bronchoscopy technology the SuperDimension device uses to navigate the lungs. The single-arm, multi-center post-market observational study […]
Clinical Trials
CeloNova wins FDA nod for U.S. stent trial
Interventional cardiology and radiology company CeloNova BioSciences said today it won FDA approval to launch an investigational device exemption trial of its Cobra PzF coronary stent system for treating patients with a high risk of bleeding. The prospective, randomized Cobra-Reduce trial is being led by Dr. Adnan Kastrati and examine the use of the stent during percutaneous […]
AAA IDE study expands, hopes to add Aortica software
Aortica said today that a physician-sponsored investigational device exemption study of abdominal aortic aneurysm-treating endografts gained FDA approval to introduce a new software-planning tool and expand the number of endografts in the study. The trial is designed to assess new technology that could reduce the need for invasive surgeries in patients with aneurysms that are “too […]
Study: Artificial pancreas outperforms pump therapy
Data from 2 new studies of closed-loop artificial pancreas indicates the device outperformed sensor-augmented pump therapy treatment for patients with Type 1 diabetes. The findings were presented September 17 at the European Association for the Study of Diabetes 2015 meeting in Stockholm, Sweden, and published in the New England Journal of Medicine. After 12-weeks being […]
Invuity touts data from device-assisted mastectomy study
Invuity (NSDQ:IVTY) said today that data from a retrospective analysis of its Eikon illuminated retractor system during nipple-sparing mastectomies showed positive economic and clinical benefits. Data from the study indicated a reduction in anasthesia time of 31 minutes, or 10%, a reduction in overall complication rates, a 70% reduction in epidermolysis and potential savings between $580 […]
Neotract touts UK NHS savings, better reimbursements
Neotract said today a new analysis from the U.K.’s National Institute for Health and Care Excellence reported a (UK £286) $443 savings per patient per day when using its UroLift system to treat enlarged prostates, compared to the most common surgical intervention. The NICE reported other benefits of the system, including preservation of sexual function, […]
MIT Researchers convert MRI scans into precise 3D heart models
Researchers at the Massachusetts Institute of Technology and Boston Children’s Hospital said today they developed a system that can take convert an MRI scan of a heart into a 3-D printed model. The printed hearts can be used to give surgeons a hands-on, tangible model of the heart they will be operating on before they touch a […]
Ventrix launches cardiac scaffolding trial
Cardiac bio-scaffold company Ventrix said it launched a trial of its VentriGel biomaterial scaffold designed to repair cardiac tissue in patients who’ve suffered a myocardial infarction. The phase 1, open-label trial is slated to enroll patients who’ve experienced their 1st myocardial infarction in the past 3 years and show signs of left ventricular dysfunction, according to […]
Harpoon Medical launches mitral valve feasibility study
Harpoon Medical said it launched an early feasibility study of its minimally invasive mitral valve repair device, with aims to use the study to support CE Mark approval in the European Union. The Baltimore, Md.-based company is developing a device to “transform the treatment of mitral regurgitation,” by eliminating the need perform an invasive breastbone […]
FDA to review HeartLight visually-guided ablation device from CardioFocus
CardioFocus said today that the FDA accepted its pre-market approval application for the HeartLight visually-guided laser balloon ablation device for treating atrial fibrillation. The PMA bid, backed by data from a 353-patient pivotal study in which subjects were randomly assigned to treatment with either the laser balloon or standard radiofrequency ablation. The results, presented last May at the annual […]
CeloNova launches coronary stent trial
Interventional cardiology and radiology company CeloNova BioSciences said today it launched a trial of its novel Cobra PzF coronary stent for treating heart disease. The e-Cobra study, a prospective registry in France, is slated to enroll 1,000 patients with a primary endpoint assessing the rate of major adverse cardiac events, such as cardiac death, myocardial […]