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.
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
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.
Medtronic on Thursday announced the European launch of its Total Across crossing catheter, angioplasty balloon technology that treats blockages and narrowing of the arteries in the lower extremities.
The Total system also treats blockages in below-the-knee blood vessels, Medtronic said.
Fridley-based Medtronic’s system recently received CE Mark approval for sale in Europe and other markets. The company also has submitted an application to the U.S. Food and Drug Administration for clearance. The FDA has not yet approved the Total Across catheter for sale in the United States.
Dr. Andrej Schmidt, an angiologist and cardiologist at the Center for Vascular Medicine at Park-Hospital Leipzig, Germany, is among the first European physicians to use the device. He called it “a tangible step forward in microcatheter design, providing extraordinary support and stability.”
Tony Semedo, a Medtronic senior vice president and president of its Endovascular Therapies business, said: “The Total Across crossing catheter expands our portfolio of medical devices for the interventional treatment of peripheral artery disease. It's a prime example of our focus on developing lesion-specific solutions and our ongoing commitment to addressing BTK lesions specifically. We are excited to be introducing this new device in Europe and look forward to bringing it to the United States in the near future."
Medtronic said the Total Across crossing catheter is the first of three new products to address below-the-knee critical limb ischemia (CLI) that the company plans to introduce around the world over the next two years. CLI is a severe obstruction of the arteries that decreases blood flow to the arms, hands, legs and feet, progressing to the point of severe pain and even skin ulcers and sores.
Other devices in Medtronic's peripheral product portfolio aimed at treating lower-extremity disease include the Complete SE (self-expanding) vascular stent, the In.Pact line of drug-coated balloons and the Admiral, Pacific and Amphirion families of percutaneous transluminal angioplasty (PTA) balloon catheters. The Pacific and Amphirion PTA balloons are designed specifically for use in below-the-knee arteries, Medtronic said.
Boston Scientific on Wednesday announced the U.S. launch and first use of its OffRoad Re-Entry Catheter System, used to treat complete arterial blockages in the major arteries of the legs. Called chronic total occlusions (CTO), such blockages are associated with advanced peripheral artery disease.
The first use of the OffRoad System was performed at a hospital in Wyoming, Mich.
The OffRoad system helps doctors navigate around complete arterial blockages by traveling outside the main channel of the artery but within the tissue of the blood vessel wall (subintimal space). Once the catheter has passed the blockage, a conical-shaped positioning balloon expands the subintimal space and directs a tiny lancet to re-enter the vessel. The doctor can then position a guidewire across the blockage and treat it using traditional techniques such as angioplasty and stenting.
“In my opinion, the biggest challenge with the subintimal approach is the ability of the device to re-enter the true vessel lumen after crossing,” said Dr. J.A. Mustapha, director of Cardiac Catheterization Laboratories, director of Endovascular Interventions and director of Cardiovascular Research at Metro Health Hospital in Wyoming, Mich. “The unique design of the OffRoad System facilitates re-entry, giving me confidence that I will be able to successfully deploy the tools I need to treat the blockage. I look forward to adding OffRoad to my endovascular toolkit to address these challenging lesions.”
Boston Scientific received U.S. Food and Drug Administration clearance in late 2013, after a favorable clinical trial. Investigators using the OffRoad System were successful in navigating around challenging blockages in 85 percent of the enrolled patients, exceeding trial goals, Boston Scientific said.
"CTOs represent one of the most challenging forms of peripheral artery disease, putting patients at great risk of limb amputation and major cardiovascular events such as heart attack and stroke,” said Jeff Mirviss, president of Peripheral Interventions at Boston Scientific. “Physicians rely on a variety of technologies and techniques to treat this condition, and with the addition of the OffRoad Re-Entry catheter system, we believe Boston Scientific is well-positioned to meet those needs with a complete portfolio of CTO solutions.”
Medtronic Inc. on Thursday announced that its SureScan pacing systems – the first and only pacing systems in the United States that have been approved by the U.S. Food and Drug Administration (FDA) for use with magnetic resonance imaging (MRI) – are now approved for MRI scans positioned on any region of the body. Previously, patients implanted with the devices could not have MRI scans of the chest area.
“This approval allows for a more streamlined MRI scanning process and makes scanning the chest easier and more accessible for patients with pacemakers,” said Pat Mackin, president of the Cardiac Rhythm Disease Management business and senior vice president at Medtronic. “Because MRI is the standard of care for soft tissue imaging and is a critical component for early detection, diagnosis and treatment, this FDA approval will help more patients with SureScan pacemakers receive the MRI scans they need.”
Generally, patients with pacemakers do not receive MRI scans because of the potential that the MRI machine could interfere with the device.
But Medtronic says that up to 75 percent of patients worldwide with implanted cardiac devices will need an MRI scan during the lifetime of their devices.
The FDA approved the first MRI compatible pacemaker available in the U.S. – Medtronic’s Revo MRI, in February 2011. A second generation pacemaker, the Advisa MRI, was approved by the FDA in January 2013.