November 3rd, 2011 by Medgadget in Research
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Medtronic received the go-ahead to begin an at-home U.S. trial of its Low Glucose Suspend technology that aims to prevent hypoglycemia by automatically stopping basal insulin delivery when measured glucose reaches a critically low level.
The pump technology is already available in Europe on the company’s Paradigm Veo insulin pump.
This is the second phase of the ASPIRE (Automation to Simulate Pancreatic Insulin REsponse) study, following the completion of the in-patient clinical study. ASPIRE is a multi-center, randomized, pivotal in-home study being conducted at multiple investigational centers to determine the safety and efficacy of the Low Glucose Suspend feature in the sensor-augmented MiniMed Paradigm insulin pump. Medtronic’s newest continuous glucose sensor, the Enlite™ sensor, will be tested as part of the overall system.
ASPIRE will compare Read more »
*This blog post was originally published at Medgadget*
October 30th, 2011 by GarySchwitzer in News, Research
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Reporter John Fauber has published the latest in his “Side Effects” watchdog series, headlined “Doctors didn’t disclose spine product cancer risk in journal: Spine-product paper omitted key data.” Excerpts:
“Doctors paid millions of dollars by Medtronic failed to identify a significant cancer risk with the company’s spine surgery product in a 2009 paper about results of a large clinical trial.
The surgeons left out important data and claimed there was no significant link between the product and cancer.
The company and doctors had become aware of information on Read more »
*This blog post was originally published at Gary Schwitzer's HealthNewsReview Blog*
October 14th, 2011 by John Mandrola, M.D. in Opinion, Research
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The news wires for atrial fibrillation were abuzz this last week. The vigor and speed with which health news travels is striking.
Since 2.6 million Americans live with AF, my guess is that many are looking at the release of the Medtronic-sponsored TTOP-AF trial with anticipation. Here is a link to the press release. The trial purported to show benefits of Medtronic’s novel phased RF ablation system in treating persistent AF.
The study was small and released at a relatively small symposium in Venice, Italy. The TTOP-AF trial randomized 210 patients with persistent AF (including flutter) to either ablation with Medtronic’s ablation system or conventional therapy with drugs and cardioversions.
They found, not surprisingly, that AF ablation reduced AF burden. AF ablation significantly reduced AF burden in 55.8% percent of patients versus only 26% of those treated with conventional medical treatment. Editorial comment: That kind of data is pretty typical.
The problem with the study Read more »
*This blog post was originally published at Dr John M*
July 5th, 2011 by GarySchwitzer in News, Research
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The Spine Journal has published a special June issue focusing on Medtronic’s INFUSE product, or rhBMP-2, a bone growth product commonly used in spine fusion surgeries. A journal news release states:
A critical review of 13 industry-sponsored studies on a spine surgery product found that the actual risk of adverse events was 10 to 50 times the estimates originally reported. The product in question is recombinant bone morphogenetic protein-2 (rhBMP-2), a controversial synthetic bone growth factor often used as a bone graft substitute in spine fusion surgeries. This eye-opening study, “A critical review of rhBMP-2 trials in spinal surgery: emerging safety concerns and lessons learned” is included in a special BMP-focused issue of The Spine Journal.
The comprehensive review found four main areas of concern among the 13 original industry-sponsored studies:
• Conflicts of interest were either not reported or were unclear in each study. Read more »
*This blog post was originally published at Gary Schwitzer's HealthNewsReview Blog*
February 18th, 2011 by Mary Knudson in News, Opinion
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This was the Guest Blog at Scientific American on February 16th, 2011.
New wave of MRI-safe pacemakers set to ship to hospitals
This week Medtronic will begin shipping to hospitals in the United States the first pacemaker approved by the FDA as safe for most MRI scans. For consumers, it is a significant step in what is expected to be a wave of new MRI-compatible implanted cardiac devices.
But this is an example of one technology chasing another and the one being chased, the MRI scanner, is changing and is a step ahead of the new line of pacemakers. The pacemaker approved for U.S. distribution is Medtronic’s first-generation pacemaker with certain limitations, while its second-generation MRI-compatible pacemaker is already in use in Europe where approval for medical devices is not as demanding as it is in the U.S. So let’s check out what this is all about — what it means now for current and future heart patients and where it may be headed.
We are all born with a natural pacemaker that directs our heart to beat 60 to 100 times a minute at rest. The pacemaker is a little mass of muscle fibers the size and shape of an almond known medically as the sinoatrial node located in the right atrium, one of four chambers of the heart. The natural pacemaker can last a lifetime. Or it can become defective. And even if it keeps working normally, some point may not function well along the electrical pathway from the pacemaker to the heart’s ventricles which contract to force blood out to the body.
Millions of people in the world whose hearts beat too fast, too slow, or out of sync because their own pacemaker is not able to do the job right, follow their doctors’ recommendation to get an artificial pacemaker connected to their heart to direct its beating. The battery-run pacemaker in a titanium or titanium alloy case the size of a small cell phone, (why can’t it be the size of an almond?) is implanted in the upper left chest, just under the skin, with one or two insulated wire leads connecting to the heart. It can be programmed to run 24/7 or to only operate when the heart reaches a certain state of irregular beating. Read more »
*This blog post was originally published at HeartSense*
