Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
Get this in your inbox everyday by subscribing to our newsletters.
5. Toshiba partners with UCI to study potential brain damage in HS football players
Toshiba said yesterday it is partnering with the University of California, Irvine to study possible brain damage incurred in high school football players.
The study is the 1st-of-its-kind investigating cerebral microbleeds as a potential precursor to chronic traumatic encephalopathy, and will operate using Toshiba’s Vantage Titan 3T magnetic resonance imager as the main diagnostic tool, the company said. Read more
4. Medtronic touts insulin pump study
Patients with Type II diabetes fared better with Medtronic’s MiniMed Paradigm Veo insulin pumps that with multiple daily injections, according to a Medtronic-backed study published in the journal Diabetes, Obesity & Metabolism.
Fridley, Minn.-based Medtronic said the 331-patient Opt2mise clinical trial compared the MDI cohort with the MiniMed-treated group; after 6 months, the MDI cohort was moved to the MiniMed arm; at 12 months, the group that moved to the insulin pump arm doubled the A1C measurement for glucose control and used 19% less insulin. Read more
3. Study: Patients with Edwards Lifesciences Sapien 3 show higher pacemaker implantation rate
A clinical study of the next-generation Sapien 3 implantable heart valve made by Edwards Lifesciences showed a higher rate of pacemaker implantation than with an earlier version of the device.
The study, published online in the journal JACC: Cardiovascular Interventions, compared the 1st 206 patients treated using the Sapien 3 with 371 patients treated with the Sapien XT transcatheter aortic valve replacement, excluding any patients previously implanted with a pacemaker or implantable cardioverter defibrillator. Read more
2. Sen. Franken pushes for review of Medtronic Infuse study
Senator Al Franken (D-Minn.) is pushing for more details on Medtronic’s study of its Infuse Bone Graft, saying that the product may have “potentially skewed the risk profile” for patients and exposed “insufficient vigilance” by the FDA, according to the Minneapolis Star Tribune.
The senator raised these concerns in a letter to both Medtronic CEO Omar Ishrak and newly appointed FDA Commissioner Robert Califf. Read more
1. FDA panel to mull St. Jude Medical’s Amplatzer PFO occluder cardiac implant
An FDA advisory panel is slated to review the clinical data behind St. Jude Medical’s bid for pre-market approval of its Amplatzer cardiac implant for treating patent foramen ovale.
The FDA’s Circulatory System Devices Panel is due to convene May 24 for a hearing on the Amplatzer PFO device, a nitinol and polyester mesh “double disc” that’s designed to close a naturally occurring hole in the heart that poses the risk of thrombosis and stroke. Read more
The post MassDevice.com +5 | The top 5 medtech stories for April 13, 2016 appeared first on MassDevice.
from MassDevice http://ift.tt/1XvUHEK
Cap comentari:
Publica un comentari a l'entrada