Who will be the next Medtronic? What will be Minnesota's next breakthrough industry? James Walsh will provide the latest information and commentary on the people, companies and trends driving innovation in Minnesota. From visionary entrepreneurs to game changing technologies, this blog offers a window into the future of Minnesota's economy.

Clinical trial results inconsistently reported among journals, government website

Posted by: James Walsh Updated: March 31, 2014 - 4:36 PM

Medical researchers often presented the findings of their clinical trials in a different way on a federal government website than they did in the medical journals where their studies were ultimately published, according to an Oregon Health & Science University analysis to be published April 1 in the Annals of Internal Medicine.

Researchers' reports in peer-reviewed medical journals often were more favorable to the drug or intervention being studied than the reports on the government website — ClinicalTrials.gov — which required data for specific categories, according to the analysis.

One of the most notable discrepancies: Of the 84 clinical trials the researchers looked at where a "serious adverse event” was reported on ClinicalTrials.gov, 33 of those trials reported fewer adverse events in the medical journals than they had reported to the government website. In 16 of those cases, no adverse events were reported in the journals.

OHSU researchers said their analysis demonstrated the ongoing problem with inaccurate and sometimes biased reporting in medical journals. But it also showed that the government website could be another viable source for objective medical information.

"There's a general recognition that adverse events historically haven't been reported consistently in the medical literature. And underreporting of these events is a major concern because it can distort how health care providers balance the benefits and harms of drugs and other medical interventions for their patients,” said Daniel Hartung, an associate professor in the Oregon State University/OHSU College of Pharmacy and lead author of the study. "But our analysis also seemed to show that ClinicalTrials.gov could be a good alternative for consumers and health care providers to get comprehensive information about a drug or medical intervention.”

For more information on the analysis, go to: http://www.ohsu.edu/xd/about/news_events/news/2014/03-31-clinical-trial-results-i.cfm

Boston Scientific's Maple Grove operations honored

Posted by: James Walsh under Minnesota technology Updated: March 20, 2014 - 11:01 AM

The Shingo Institute at Utah State University has awarded Boston Scientific a Shingo Award in recognition of the company’s “delivering world class results and demonstrating an ongoing commitment to leading and influencing a strong culture of operational excellence at its Maple Grove, Minn. manufacturing facility,” Boston Scientific said in a statement.


“Receipt of the Shingo Silver Medallion signifies an organization’s strong use of tools, techniques and mature systems for business improvement,” said Robert Miller, executive director at the Shingo Institute.

Said Dale Hentges, vice president of Boston Scientific’s Maple Grove operations: “We are proud of our consistent and sustained efforts to drive quality, reduce cost and deliver innovative new products across our global operation. The Shingo Model is a world-class standard for operational excellence, and our team is honored to receive this recognition for our progress and efforts.”

For more information about the Shingo Award and Boston Scientific, go to: www.bostonscientific.com

Consumers Union to lobby at meeting of orthopedic docs in New Orleans

Posted by: James Walsh Updated: March 11, 2014 - 5:27 PM

Consumers Union, the policy and advocacy division of Consumer Reports, is taking its campaign to convince medical device companies to provide warranties for hip and knee implants directly to the doctors who perform these operations. CU has launched an ad campaign and will be conducting outreach activities this week during the American Association of Orthopaedic Surgeons (AAOS) conference in New Orleans.

Consumers Union has called on medical device manufacturers to provide warranties to cover the cost of replacing hip or knee implants that fail prematurely because of a product defect.

This week’s ad campaign includes an ad in support of the campaign in the New Orleans edition of USA Today, a mobile billboard that will circle the Morial Convention Center and ads at the Louis Armstrong New Orleans International Airport.  Consumers Union staff and activists will be outside the convention center where the AAOS annual meeting is taking place.

“Getting a hip or knee implant is a major life decision and high stakes purchase for patients,” said Lisa McGiffert, director of Consumers Union’s Safe Patient Project (www.safepatientproject.org).  “Medical device makers should be willing to provide a warranty that spells out how long they will stand by their products and a process for getting it replaced at no cost if the implant turns out to be defective.”

Nearly 1.2 million hip and knee surgeries are done in the U.S. each year – making them an increasingly common procedure.  Demand is expected to continue rising.  By 2030, an estimated 4 million of these procedures will take place annually.  More than half of those patients are expected to be under 65 years old.

Most hip and knee implants perform well and can last up to 20 years.  But the AAOS estimates that 10 percent will fail for a range of reasons, from infection and trauma to loosening or poor implant positioning.

2014 Medtronic Global Heroes applications sought

Posted by: James Walsh under Minnesota innovation, Minnesota technology Updated: March 10, 2014 - 3:49 PM

Are you a distance runner who has benefitted from medical technology? Medtronic wants you… to run as a Global Hero.

Once again, the Fridley-based medical technology giant is sponsoring its Global Heroes team and will select up to 25 runners, who will receive a paid entry for themselves and a guest to the Medtronic Twin Cities Marathon or the Medtronic TC 10 Mile. They will also receive airfare and accommodations for the Global Hero and a guest.

The 2014 Medtronic Twin Cities Marathon weekend will take place October 3-5, 2014.  Since 2006, 184 runners representing 27 different countries and a myriad of chronic and degenerative disease conditions have run the beautiful course that winds through the lakes and neighborhoods of Minneapolis and St. Paul.

Applications and information for the 2014 Medtronic Global Hero team are available at medtronic.com/globalheroes.  The application deadline is April 25, 2014.

To qualify as a Global Hero, runners must currently be using a medical device therapy to treat the following disease categories: heart disease, diabetes, chronic pain, spinal disorders, or neurological, gastroenterology and urological disorders. Eligible medical devices include any pacemaker or implantable cardioverter defibrillator (ICD), any spinal device, any neurological device, any insulin pump, or any heart valve. The device does not have to have been made by Medtronic.

Runners will be chosen by a committee of Twin Cities In Motion. Certain conditions may apply and applicants must certify that they have discussed race participation with their physician.

Tinnitus sufferers sought for NIH trial

Posted by: James Walsh Updated: March 6, 2014 - 11:56 AM

National Institutes of Health researchers are launching a clinical trial to test a device that seeks to rewire parts of the brain in hopes of reducing or eliminating tinnitus, a persistent buzzing or ringing in the ears in the absence of any real sound.

The small clinical trial is recruiting volunteers and will be conducted at three centers – at the University of Texas at Dallas, the University at Buffalo (SUNY), Buffalo and at the University of Iowa, Iowa City. An additional site will be added later in the year. More information about the trial and enrollment is available on the study’s website, http://www.tinnitustrial.com, or at http://www.ClinicalTrials.gov.

Roughly 10 percent of the adult population of the United States has experienced tinnitus lasting at least five minutes in the past year, and approximately 10 million have been bothered enough by the condition to seek a doctor. Although tinnitus may be only an annoyance for some, for others the relentless ringing causes fatigue, depression, anxiety, and problems with memory and concentration. Available treatments help some people cope, but current therapies lack the potential to significantly reduce the bothersome symptoms of tinnitus.


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