Some solid revenue growth for Medtronic, compared with the same quarter a year ago, were somewhat spoiled by a $200 million write down following the poor outcome from its much vaunted Symplicity HTN-3 Study.
Medtronic
Medtronic Insertable Monitor Outperforms Current Standard of Care in AF Detection
Atrial Fibrillation raises stroke risk five-fold. But it’s often asymptomatic and paroxysmal, leaving patients with a risk they either know nothing about or that medial professionals can’t detect. Medtronic’s monitoring solution has now been found to outperform the current standard of care, raising the possibility of reducing incidence of cryptogenic stroke.
Medtronic Launches ‘TOTAL Across’ Crossing Catheter in Europe
Medtronic has initiated the European launch of the TOTAL across crossing catheter, which recently received the CE Mark as a tool for improving blood flow through narrowed or occluded lower-extremity arteries, including those in the especially challenging below-the-knee (BTK) vessel bed.
Medtronic’s Valiant Captivia Stent Graft Now FDA Approved for Aortic Dissections
Medtronic has taken the opportunity presented by this weeks Thoracic Society meeting to announce that it has gained U.S. FDA approval for its Valiant Captivia Thoracic Stent Graft System to be used in the treatment of type B aortic dissections.
FDA OK’s Medtronic Pacemakers for Full-Body MRI Scans
Medtronic, Inc. has announced the U.S. FDA approval of its Medtronic SureScan® pacing systems that are compatible with use of MRI scanning on any region of the body.
Symplicity Bombshell as U.S. Pivotal Trial Fails to Meet Primary Efficacy Endpoint
Renal denervation therapy has had a bad day with the news that the biggest study and first to be sham-controlled, has not delivered its primary efficacy endpoints. Consequences for Medtronic’s Symplicity programme are serious enough for the company to be considering incurring an impairment charge.
Medtronic Acquires TYRX, Inc., with its Antibacterial Device Envelopes
We’ve covered TYRX’s clever antibacterial, FDA cleared, device envelopes before, mainly because it’s an interesting concept. Medtronic thinks so… it likes it so much it’s bought the company.
First Patients Randomized in SYMPLICITY HTN-4 U.S. Study of Renal Denervation in Moderate Uncontrolled Hypertension
Medtronic, Inc., has kicked off its SYMPLICITY HTN-4 study with the news that the first patients have been randomized. The study, which started enrolling in November 2013 will evaluate the Symplicity™ renal denervation system in patients with moderate uncontrolled hypertension
Shrinking Pacemakers: First Human Implant of World’s Smallest Yet
Medtronic, Inc. is trumpeting the first-in-human implant of the world’s smallest pacemaker, called the Micra™ Transcatheter Pacing System. The device was implanted in a patient in Linz, Austria as part of the Medtronic global pivotal clinical trial.
Seven Year Data Shows Sustained Results with Medtronic Cervical Disc Replacement
Data presented at last week’s Cervical Spine Research Society annual meeting indicate that significant improvements in pain and functional outcomes achieved by 1.5 months in both groups were sustained at seven years.
First Implants of DBS System that Monitors Brain Activity During Therapy Delivery
Medtronic’s Activa® PC+S Deep Brain Stimulation System closes the loop in understanding the impact of this therapy, by monitoring the impact of the therapy on specific areas of the brain in real time.
Delamination Risk Prompts FDA Class I Recall of Medtronic’s Guidewires
The US FDA has issued its highest category of of recall (Class I) for a variety of Medtronic Guidewires, due to the potential for their PTFE coating to part company with the core.
CoreValve® Back in the Game with German Court Appeal Win
Medtronic, Inc. has announced that a German court has ordered the discontinuation, in its entirety, of a prior court ruling that prohibited the company from commercially marketing or selling the CoreValve® System in Germany since August 26, 2013.
Medtronic’s Software Gains FDA Nod for Use in Detecting ICD Lead Issues with Non-Medtronic Leads
Medtronic’s Lead Integrity Alert software is designed to detect implantable pacing lead failures better than impedance monitoring alone. Now the company has gained FDA approval for its system to be used in the detection of problems with other manufacturers’ leads, which opens up a further 12,000 case in the US alone.
“All Comers” Study Tests Medtronic’s Resolute Integrity vs Boston’s Promus Element
Medtronic is trumpeting quite a landmark with the publication of a first head-to-head randomized controlled trial of “third-generation” durable-polymer drug-eluting stents for the treatment of coronary artery disease in an “all-comers” patient population. Resolute Integrity’s greater longitudinal strength doesn’t seem to play out in better target vessel failure stats.
L5/S1 Lateral Disc Access with New OLIF51 System
Medtronic, Inc. has used the annual meeting of the Congress of Neurological Surgeons in San Francisco, at which to announce the launch of the first procedure that allows lateral access to the most common operative level of the spine.