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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.

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.

Medtronic begins enrollment in global clinical trial for CRT-P.

Posted by: James Walsh Updated: January 10, 2013 - 12:05 PM

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Medtronic on Thursday announced that it is enrolling the first patients in its MIRACLE EF global clinical trial to evaluate the effectiveness of cardiac resynchronization therapy-pacemakers (CRT-Ps) in delaying the progression of heart failure in patients with mildly reduced heart pumping function.
 
The study will be the first to evaluate CRT-P in what Medtronic calls a widely underserved patient group – those who have a slightly reduced left ventricular ejection fraction (LVEF) but whose hearts work a bit more efficiently than heart failure patients who are currently approved for the device.
 
The CRT-P devices used in MIRACLE EF are not approved by the FDA for the patient population being studied. Dr. Edward Schloss performed the first implant at The Christ Hospital's Lindner Research Center in Cincinnati, Ohio. The primary investigator for the site is Dr. Greg Egnaczyk.
 
"Previous studies have proven the real-world therapeutic benefits of CRT in treating mildly to severely symptomatic heart failure patients with moderately to severely reduced cardiac pumping capacity and electrical dyssynchrony," said Professor Cecilia Linde of Karolinska University Hospital in Stockholm, and worldwide principal investigator in the trial. "Through this large global study we hope to further our research on the overall effectiveness of CRT-P by showing its benefit in treating patients with mild-to-moderate heart failure symptoms, but with milder impairment of heart pumping capacity than previously studied."
 
Medtronic said that up to 2,300 patients at approximately 275 centers throughout the world – including in the United States, Canada, Europe, Japan and developing markets – will be enrolled in the trial. Patients will be followed for at least two years or until close of the study. The trial is expected to take four to five years to complete.
 
"We are hopeful that, when completed, MIRACLE EF will influence clinical practice guidelines regarding the use of advanced cardiac resynchronization devices and potentially lead to another expanded indication for Medtronic CRT devices," said David Steinhaus, M.D., vice president and general manager, Heart Failure, and medical director for the Cardiac Rhythm Disease Management business at Medtronic. "We look forward to the positive implications these findings could have on heart failure patients whose disease is less pronounced, yet who still experience symptoms and need advanced therapeutic solutions."
 

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