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.
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.”
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.
AUM Cardiovascular, an award-winning Minnesota medical technology startup, is sponsoring a major pivotal study to prove its non-invasive technology can detect obstructive coronary artery disease (CAD) just as well as a Single Photon Emission Computed Tomography (SPECT) nuclear stress test.
SPECT is the most common nuclear scanning test for diagnosing problems with blood flow to the heart.
AUM’s CADence system is a handheld device, used by a cardiologist, that can quickly spot blockages in blood vessels around the heart after just a few measurements. It uses an algorithm to detect changes in pressure within the blood vessels – changes that could indicate whether those arteries are clogged with plaque.
Marie Johnson, AUM CEO, said CADence is as accurate as a treadmill stress test. Now the study will attempt to prove it.
AUM’s clinical study will enroll 729 patients at 15 trial centers across the United States. Dr. Joseph Thomas, an Assistant Professor of Clinical Medicine at the UCLA David Geffen School of Medicine, will chair the study.
Founded in 2008, AUM Cardiovascular has raised over $5 million from angel investors. In competition against 1,000 companies, AUM won the 2011 Minnesota Cup, an annual statewide competition for promising startups. AUM was recently named one of the top 10 start-up companies in the world by the Innovations in Cardiovascular Intervention conference in Tel Aviv, Israel. The company is located in Northfield, MN.
For more information, go to aumcardio.com.