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.
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.
The University of Minnesota is recruiting for the Technological Leadership Institute’s newly launched MS program in medical device innovation.
According to the U, the program “will prepare students to effectively manage the innovation challenges of the complex, highly regulated global medical device industry.”
More than 250,000 people in the state of Minnesota work in the medical device industry, according to the trade association LifeScience Alley, and some of the world’s top medical technology companies are headquartered or have operations in Minnesota.
Medtronic, St. Jude Medical and Boston Scientific are all major players in the med tech field and there are hundreds of other, smaller companies in Minnesota. The U of M’s new program hopes to prepare students for success in this growing field. The master’s in medical device innovation program integrates multiple disciplines, including technology innovation, project and business management, intellectual property, regulatory affairs and public policy.
Daniel L. Mooradian is director of graduate studies for the new program. He is a former member of the faculty in biomedical engineering and in the Medical School at the U of M. He has held research and management positions at Boston Scientific and Synovis Life Technologies (Baxter International). He has also founded and advised a number of med tech start-ups, according to the U.
“The technical training that undergraduate students generally receive – while essential – is not sufficient for success in the medical device industry,” Mooradian said. “This program is designed to provide students with the industry knowledge needed to give them a competitive career advantage and to give their companies enhanced capacity for innovation.”
The program is scheduled to start its first class in June. The Technological Leadership Institue is part of the University of Minnesota’s College of Science and Engineering.
Medtronic on Monday announced the enrollment of the first patient in its Victory AF clinical trial, a study involving patients with persistent or long-standing persistent atrial fibrillation. Patients in the trial will undergo a procedure with Medtronic’s Phased Radiofrequency (RF) system. The study will evaluate the safety of the system, while collecting data on the system’s effectiveness.
The system delivers customized radiofrequency energy to eliminate or block abnormal electrical impulses in the left atrium that initiate or sustain atrial fibrillation. The multi-electrode catheters are intended to allow doctors to identify and selectively ablate a broad area of heart tissue without the need for single-point catheters or complex mapping and navigation equipment.
The Medtronic Phased RF System is currently approved for use in areas of Europe, Asia, Africa, Australia, and Canada. More than 20,000 patients in 26 countries have been treated since January 2009. The system is not yet approved for sale in the United States.
Up to 350 patients will enroll in the trial at 40 centers in the U.S., Canada and Europe. The trial will examine the 30-day procedure-related stroke rate and device-related stroke rate. Six-month effectiveness, as well as rates of pulmonary vein stenosis and acute procedural success, will also be measured.
The principal investigator is Dr. Greg Michaud, assistant professor, Harvard Medical School, and director of the Center for the Advanced Management of Atrial Fibrillation at Brigham and Women’s Hospital in Boston. The first patient in this study was recently treated by Dr. David DeLurgio of Emory University Hospital Midtown in Atlanta.
“In strong collaboration with the [U.S. Food and Drug Administration], we designed the VICTORY AF trial to evaluate the safety of Phased RF ablation in patients who suffer with persistent or long-standing persistent AF,” said Reggie Groves, vice president and general manager of the AF Solutions division at Medtronic. “We expect this trial will demonstrate its safety and benefit for this patient population.”
Persistent atrial fibrillation is defined as lasting more than seven days but less than one year, or lasting fewer than seven days but requiring treatment with medication or electrical current. Long-standing persistent AF is defined as lasting more than one year but fewer than four years.
In the United States, AF ablation catheters currently are available only for treating the mildest form of AF, in which the heart’s upper chambers beat rapidly and irregularly during episodes lasting from a few minutes to a few days. AF can progress into a persistent or long-standing persistent state, where patients often cannot be effectively treated with medication. Patients with persistent and long-standing persistent AF can have debilitating symptoms and are at elevated risk for stroke, hospitalizations and reduced quality of life.
Boston Scientific, a global medical technology company that employs thousands of Minnesotans, on Tuesday announced CE Mark approval of its X4 line of quadripolar CRT-D systems, including the AUTOGEN X4, DYNAGEN X4, and INOGEN X4 cardiac resynchronization therapy defibrillators (CRT-Ds) -- as well as its ACUITY X4 quadripolar LV leads and the ACUITY PRO lead delivery system. Leads are the wires that connect defibrillators and pacemakers to the heart.
The ACUITY X4 leads are designed with multiple electrodes that help doctors accommodate differences in patient anatomy. With multiple electrodes, the device can deliver therapy even if there is scar tissue that could block an electrical signal. The leads also feature multiple options for attaching the lead to the heart, as well as what Boston Scientific said is the industry's smallest lead tip to enable doctors to access blood vessels unavailable to other quadripolar leads.
One of the first implants was performed by Prof. Antonio Curnis, head of Electrophysiology, Brescia University, Civili Hospital, Brescia, Italy, and Dr. Luca Bontempi, an electrophysiologist.
"The unique design of the ACUITY X4 lead allows me to pace from more optimal locations while enabling excellent stability of the lead, low battery consumption and avoiding phrenic nerve stimulation, which are all important issues for CRT patients," said Prof. Curnis. "Thanks to the 17 pacing vector options, it is possible to manage micro dislodgments of the lead and optimize pacing threshold without additional procedures, drastically reducing the risk to patients. This, along with Boston Scientific'soutstanding battery technology, delivers a CRT-D system that truly benefits patients over the long term."
Following CE Mark approval of the X4 quadripolar CRT-D systems, Boston Scientific plans to start a global clinical trial to gather additional data. The device is not yet available for sale in the United States.
"Heart failure is a major cardiovascular problem and CRT-Ds can save lives and improve quality of life. The CE Mark approval of our innovative quadripolar CRT-D systems is truly a milestone when it comes to treating patients with heart failure and at risk of sudden cardiac arrest," said Michael Onuscheck, senior vice president and president, Boston Scientific Europe. "We are also excited to provide physicians with a CRT-D system that can significantly improve the implant experience."
For more information, go to: http://www.bostonscientific.com