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 London man recognized for being CardioSmart

Posted by: James Walsh under Minnesota newsmakers Updated: February 24, 2014 - 11:26 AM

A Minnesota man has been recognized by the American College of Cardiology for transforming his life, and his body, after a procedure to treat his atrial fibrillation.

Marcus McCleery of New London weighed nearly 400 pounds, largely due to his heart condition, making it nearly impossible for him to live an active life. But, after two surgeries in two years, McCleery took back control of his life.

Over time, as he became more and more active and was smarter about what he ate, McCleery lost 183 pounds. The one-time couch potato now participates in triathlons, is an avid cyclist, runner and kayaker. He volunteers for the Minneapolis Heart Institute Foundation. He also created the Web site: , www.move15minutesaday.com.

For his example, McCleery was recognized by the ACC’s “I am CardioSmart” Contest.

The Star Tribune featured McCleery’s journey here: http://www.startribune.com/lifestyle/health/181118921.html

For more information about the symptoms of atrial fibrillation and its treatments, go here: www.cardiosmart.org/Heart-Conditions/Atrial-Fibrillation.

Mercy Hospital first to use new FFR technology by Eden Prairie company

Posted by: James Walsh under Minnesota innovation Updated: February 19, 2014 - 11:34 AM

ACIST Medical Systems of Eden Prairie on Wednesday announced the first successful human case to use its RXi Rapid Exchange FFR System in the United States.

Dr. Jeff Chambers of Metropolitan Heart and Vascular Institute in Coon Rapids performed the Fractional Flow Reserve (FFR) procedure on Monday. FFR is used to detect and assess blockages in coronary arteries that could require angioplasty.

The new technology was designed to provide physicians with a faster and easier way to perform FFR procedures, ACIST said in a statement.

“The ACIST Rapid FFR System offers a significant step forward in diagnostic assessment,” said Chambers, an interventional cardiologist and the director of the Cardiac Catheterization Lab at Mercy Hospital. “With Rapid FFR, measurements can be obtained quickly and easily without disrupting cath lab workflow… The time savings and ease of use are significant advantages, especially in complex coronary interventions like the ones we routinely perform here at Mercy."

Tom Morizio, president and chief operating officer of ACIST, said: “The RXi Rapid Exchange FFR System is a major step forward in the transformation of ACIST…. The technology in the RXi Rapid Exchange FFR System will continue to evolve and advance our mission to simplify the complexities in the Cath Lab.”

ACIST received FDA clearance for the RXi system in January. The company conducted a clinical trial in New Zealand and is currently performing an additional study in Europe. ACIST is moving forward with a limited market rollout of the system in advance of a full global release in the spring of 2014.  For more information about ACIST, go to: www.acist.com.

Heart disease, stroke risk estimator app available for health care pros

Posted by: James Walsh Updated: February 18, 2014 - 11:47 AM

I just got this from the American College of Cardiology. The app is available for iOS and Android:

WASHINGTON (Feb. 18, 2014) —The American College of Cardiology and the American Heart Association have released a mobile and Web-based app for health care professionals to use with their patients in determining 10-year and lifetime risks for developing atherosclerotic cardiovascular disease (ASCVD), the major cause of heart attack and ischemic stroke.

“This tool is meant to facilitate a conversation between the health care provider and the patient about the patient’s risk of heart attack and stroke and how best to reduce those risks,” said John G. Harold, MD, MACC, president of the American College of Cardiology. “While we hope the app will make the risk assessment guidelines more accessible, it is not a substitute for face-to-face engagement. It is a tool to help health professionals and patients work together as part of a discussion of the patient’s medical history and lifestyle.”

The ASCVD Risk Estimator, a mobile and Web version of the Excel-based calculator released with the ACC/AHA Cardiovascular Risk Guideline released in November 2013, uses a patient’s age, sex, race, total cholesterol, HDL cholesterol, systolic blood pressure, blood pressure-lowering medication use, diabetes status and smoking status to estimate their 10-year and lifetime risk of heart attack and ischemic stroke. The app also helps health care professionals determine whether statin therapy is appropriate, what intensity of statin therapy is needed, how to address safety concerns of statin therapy, and what lifestyle changes should be made.

“We are pleased the risk assessment guidelines are now available in easy to access tools,” said Mariell Jessup, MD, president of the American Heart Association. “The guidelines were broadened late last year to include the assessment for risk of stroke as well as heart attack. This app incorporates the stroke risk as well as the new gender- and ethnicity-specific formulas for predicting risk in African-American and white women and men found in the guidelines, and it looks beyond traditional short-term (10-year) risk estimates to predict an individual’s lifetime risk of developing heart disease and having a stroke.” 

The ASCVD Risk Estimator mobile app can be downloaded for free from the iTunes and Google Play app stores. The Web version is available on CardioSource.org and on myamericanheart.org.

Medtronic announces European launch of system to treat lower extremity blockages

Posted by: James Walsh under Minnesota innovation, Minnesota technology Updated: February 13, 2014 - 11:10 AM

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 launches catheter system to treat complete blockages of leg arteries

Posted by: James Walsh under Minnesota technology Updated: February 5, 2014 - 12:24 PM

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.”


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