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Wednesday June 19, 2013

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.

New Medical Devices Center at U to have Open House

Posted by: James Walsh under Minnesota innovation, Minnesota technology Updated: May 30, 2013 - 11:28 AM

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By now, you may have heard that the medical device industry is more than a little important in Minnesota. Giants like Medtronic, St. Jude Medical and Boston Scientific all have headquarters or substantial operations here. Hundreds of smaller start-ups continue working to fuel innovation and become the next big thing.
 
The University of Minnesota, too, is a major player in the medical device game here. Now, the U is opening a new state-of-the-art medical devices laboratory – and the public gets a first look.
 
An open house is scheduled from 10 a.m. to 5 p.m. on Tuesday, June 4 at the University of Minnesota’s Mayo Building, Suite G217, 420 Delaware St. SE, Minneapolis. Guided tours are offered throughout the day.
RSVPs are not required but appreciated and can be sent to Trisha Johnson at johnsont@umn.edu or 612-626-5642. For detailed directions to the center visit, http://z.umn.edu/mdcdirections.
 
The 8,000-square-foot Medical Devices Center facility was specifically built for designing, building and testing new medical devices. According to the University, researchers had outgrown their previous location in the University’s Shepherd Labs that opened in 2008 with 2,500 square feet. That facility grew to 5,000 square feet in recent years.
 
University officials say the new center will foster even greater collaboration between the University’s College of Science and Engineering, and Academic Health Center units in Medicine, Pharmacy, Dentistry, Nursing and Veterinary Medicine. Equipment and labs are used for designing and testing medical devices. Facilities include a 3D Virtual Design Lab, Imaging Lab, Anatomy and Physiology Lab, Mechanical and Electronic Fabrication Labs, Wet Lab, Brainstorming Rooms, and more.
 
Student and faculty researchers will demonstrate new equipment during the tour and highlight past successes in developing medical devices at the University.
 
The center hosts the world’s largest annual Design of Medical Devices Conference connecting industry and academia. It is also model for turning research and development ideas into marketable products. Officials say the center’s innovation fellows have filed 120 invention disclosures over the past five years. Based on these invention disclosures, the University has filed 58 patent applications.
 
In addition to driving medical device innovation, the Medical Devices Center trains the next generation workforce. The center’s Innovation Fellows program draws medical and engineering professionals from around the world to train future innovation leaders in Minnesota. The center also provides support and training for more than 100 undergraduate and graduate students per year.
 
The Medical Devices Center is part of the University of Minnesota’s Institute for Engineering and Medicine (IEM) established in July 2007. IEM is an initiative jointly sponsored by the University’s College of Science and Engineering and Academic Health Center. The IEM fosters a wide range of high level, goal-oriented interdisciplinary research, uniting faculty in health sciences and various engineering, science and mathematics departments.
 
Here are some links:
Medical Devices Center: http://www.mdc.umn.edu/

Ricky Rubio joins forces with Medtronic Foundation

Posted by: James Walsh Updated: February 6, 2013 - 11:26 AM

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In his still-new career as a point guard for the Minnesota Timberwolves, Ricky Rubio has made a habit of making heart-stopping plays. Now the Spanish star is being used to help teach the public how to re-start a heart.

Rubio is working with the Medtronic Foundation this month to help save young lives from sudden cardiac arrest (SCA). Through the foundation’s HeartRescue Project, Rubio will lend a "virtual" hand in teaching the public how to respond quickly to an emergency.

SCA is defined as “a sudden, abrupt loss of heart function primarily caused by rapid and/or chaotic electrical activity.” It often occurs without warning and can kill a person within minutes unless treated with CPR and a defibrillator.

According to the Medtronic Foundation, sudden cardiac arrest is the leading cause of death among young athletes, with a young person dying from SCA every three days. According to the American Academy of Pediatrics, 2,000 Americans under the age of 25 die of SCA annually. The risk of sudden cardiac death is three times greater in competitive athletes. In all, nearly 385,000 Americans die from SCA each year – more than breast cancer, colon cancer, lunch cancer and prostate cancer combined.

In 2012, the HeartRescue Project produced the “Save-a-Life Simulator,” an online video tool featuring an SCA victim stricken at a busy shopping mall. The simulator strung together many possible reactions to witnessing SCA in real time to help people learn which steps to take in a real emergency. According to the Medtronic Foundation, since the simulator’s launch, more than five million people have learned how to save a life.

Now Rubio is helping unveil the newest “Save-a-Life Simulator.” Using first-person point-of-view videos, the viewer joins Rubio for a workout at the gym where they both witness a person collapse from SCA.

In the video, Rubio helps guide visitors through a series of critical choices, starting with an initial decision to help the victim or ignore the situation and keep working out. Visitors then follow a series of hands-on decisions. The folks at the Medtronic Foundation say they hope Rubio's involvement will draw attention to sudden cardiac arrest – as well as provide basic technique for how to save a life.

In addition to the simulator, Rubio and Timberwolves players will attend clinics hosted at Twin Cities' schools in February as part of the Timberwolves' FastBreak Foundation WolvesFit month. These clinics will focus on health and fitness and show students the importance of responding to a victim of SCA - knowing that it could happen to anyone in their school.

To participate in the online simulator and learn more about sudden cardiac arrest, go to HeartRescueNow.com.

 

Kips Bay Medical enrolls first U.S. patient in mesh trial

Posted by: James Walsh Updated: February 5, 2013 - 4:48 PM

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Kips Bay Medical on Tuesday announced the first implant in the United States as part of its eMESH I clinical feasibility trial. The eMESH trial will collect patient data on the performance of Kips Bay’s eSVS Mesh, which is designed to strengthen veins used in coronary bypass graft surgery and keep the grafted vessel from closing.
 
The first U.S. implant was performed at the Northeast Georgia heart Center in Gainesville, Ga., by Dr. J. Alan Wolfe.
 
“Our first implant of the eSVS Mesh graft went very smoothly and the patient is doing well and recovering normally. I am very impressed by the ease of use and excellent handling characteristics of the eSVS Mesh.” Wolfe said. “Bypass graft closure is the most significant problem that we find in patients with atherosclerotic disease. The eSVS Mesh device is designed to prevent saphenous vein grafts from closing. I believe that it holds the potential to favorably impact the patient’s quality of life and reduce the need for future, costly coronary re-interventions.”
 
Kips Bay CEO Manny Villafana said: “We are excited to begin clinical study of our eSVS Mesh here in the United States. This first U.S. implant represents another significant milestone in the development of our eSVS Mesh technology for coronary artery bypass surgery.”
 
The eMESH I trial is a multi-center, randomized study designed to demonstrate the initial safety and performance of the eSVS Mesh for use as an external saphenous vein graft support device during coronary artery bypass graft (CABG) surger. Kips Bay officials said they expect to enroll up to 120 patients at eight European and four U.S. sites. They hope to use the data from this study as the basis for later requesting a pivotal trial in the United States.
 
Kips Bay Medical was founded in 2007 and is headquartered in Minneapolis. Its eSVS mesh is a metal mesh sleeve that, when placed on the outside of a saphenous vein graft during CABG surgery, is designed to improve the structure and long-term performance of the graft.

Evera ICDs get CE Mark for sale in Europe

Posted by: James Walsh Updated: February 5, 2013 - 10:42 AM

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Medtronic this week announced European (CE Mark) approval of its Evera implantable cardioverter-defibrillators (ICDs). According to Medtronic, Evera offers increased longevity and “the most advanced shock reduction technology available.”
 
Designed with thin, smooth edges and a contoured shape, Evera ICDs are supposed to increase patient comfort by fitting better inside the body. The device is not approved for sale in the U.S.
 
According to Medtronic, Evera boasts a battery life of up to 11 years. That’s a 25 percent increase in battery longevity, Medtronic said. It is paired with Medtronic’s Quattro Secure lead. A lead is the wire that connects an ICD to the heart. The Quattro Secure is the only lead with 10 years of proven performance with active monitoring, Medtronic said.
 
As younger patients are increasingly fitted with ICDs and pacemakers, device-makers are working to develop technology that is more durable and more able to survive the stresses of active lives. Medtronic says its Evera family of ICDs is a step in that direction.
 
“Evera offers patients and physicians a unique standard in modern ICD treatment," said Dr. Joerg O. Schwab, professor of cardiology at the University Hospital of Bonn, in Bonn, Germany. "With a new shape designed for comfort, greater longevity, the most advanced shock reduction capabilities available on the market, and a best-in-class lead with 10 years of proven reliability, this advanced comprehensive ICD technology works to improve patients' overall quality of life."
 
Shock reduction also has become a focus. ICDs deliver a life-saving jolt to the heart, but it can be a painful punch to the chest when the device inaccurately senses the need to provide therapy. Medtronic says its exclusive SmartShock Technology uses an improved shock reduction algorithm that enables the device to better differentiate between dangerous and harmless heart rhythms.
 
According to the Fridley med tech company, the device has proven to be 98 percent inappropriate shock-free rate after a year.
 
"Our new, Evera family of ICDs delivers on our strategy to develop a comprehensive system to reduce many common complications that have been part of receiving an ICD; we have introduced a unique shape to enhance patient comfort, incorporated the most advanced shock reduction technology available, developed a longer-lasting battery than its predecessors, while using the most reliable ICD lead (Sprint Quattro) available," said Dr. Marshall Stanton, vice president and general manager of the tachycardia business at Medtronic.

Kips Bay Medical to enroll more patients in U.S. feasibility trial

Posted by: James Walsh Updated: January 23, 2013 - 9:15 AM

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A local medical technology company, Kips Bay Medical, announced Wednesday that it has received approval from the U.S. Food and Drug Administration to enroll additional patients into its eMESH I clinical feasibility trial.
 
Kips Bay Medical, headquartered in Minneapolis, was founded by Chairman and CEO Manny Villafana. He also founded CPI/Guidant and St. Jude Medical. Villafana started Kips Bay Medical in 2007.
 
The feasibility trial is a multi-center study of Kips Bay Medical’s eSVS Mesh in coronary artery bypass graft surgery. The mesh is used to support blood vessels that are taken from another part of the body and used to bypass the blocked coronary artery. The mesh surrounds the vein like a sleeve, and is designed to improve the structural characteristics and long-term performance of the graft.
 
The FDA initially approved a staged enrollment in the United States, starting with five patients at up to four sites. The FDA now has increased the number of patients from five to 15.
 
As part of the trial, Kips Bay Medical will provide six-month follow up angiograms on the first 10 patients enrolled in trials in Europe and the U.S. combined. The FDA will review those angiograms and, if it finds them acceptable, Kips Bay Medical said it expects to be allowed to enroll the remaining U.S. patients in the trial here.
 
All told, the company said it expects to enroll up to 120 patients at eight European and four U.S. sites. Data from the feasibility study will be used as the basis for a pivotal trial in the U.S. to attempt to gain FDA approval.

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