Friday January 4, 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.
Medtronic renal denervation trial continues to show positive results
Posted by: James Walsh Updated: December 17, 2012 - 4:06 PM
Medtronic on Monday reported positive one-year results of its worldwide clinical trial for renal denervation, a treatment for medication-resistant high blood pressure.
Medtronic’s Symplicity HTN-2 trial showed that patients who received the treatment maintained a significant drop in blood pressure a year after having the procedure, Medtronic reported. In addition, 35 patients who were in the control group of the study – those who had been treated with medication only for the first six months – had denervation after that and showed a drop in blood pressure.
There were no device-related serious problems, no late complications and no significant decline in kidney function after 12 months, Medtronic said.
Study results were published online in Circulation, the Journal of the American Heart Association. Symplicity is not yet approved by the U.S. Food and Drug Administration for sale in the United States. A total of 106 patients at 24 centers around the world are participating in the HTN-2 trial, with half receiving renal denervation in addition to medication and half receiving medication only. After the first six months of the trial, patients on medication only also were offered denervation.
The therapy involves using radio frequency energy to burn spots on the nerves in the wall of the renal arteries. Those nerves are part of the sympathetic nervous system, which affects the major organs responsible for regulating blood pressure – the brain, heart, kidneys and blood vessels. It is a one-time treatment and does not require that a device be implanted.
Treatment-resistant hypertension is persistently high blood pressure despite a patient taking three or more blood pressure medications. An estimated 120 million people worldwide have this problem, putting them at risk for kidney disease, stroke, heart attack and heart failure.
The Symplicity system was launched in April 2010 and is available in parts of Europe, Asia, Africa, Australia and the Americas. It has been used to treat thousands of patients with treatment-resistant hypertension worldwide, Medtronic said Monday.
The FDA granted Medtronic approval for the protocol for SYMPLICITY HTN-3, the company's U.S. clinical trial of Symplicity in August 2011. More information about HTN-3 can be found at www.symplifybptrial.com.
Boston Scientific launches new spinal cord stimulator in Europe
Posted by: James Walsh Updated: December 7, 2012 - 10:37 AMBoston Scientific on Friday announced CE Mark approval and has launched its new spinal cord stimulator system in Europe. The Precision Spectra Spinal Cord Stimulator (SCS) System is the world's first and only SCS system with 32 contacts and 32 dedicated power sources, according to Boston Scientific. It is designed to provide relief to a wide range of patients who suffer from chronic pain.
The first commercial implant of the Precision Spectra System was performed last month at the Basildon and Thurrock University Hospitals in the United Kingdom.
Chronic pain affects one in five adults in Europe – about 95 million people 15 to 64 years of age, Boston Scientific says.
Spinal cord stimulators deliver electrical pulses from an implantable pulse generator to leads with stimulating contacts. These electrical pulses mask pain signals traveling up the spinal cord to the brain. Until now, Boston Scientific said, such systems have offered a maximum of 16 contacts and two lead ports, with each lead port allowing the placement of one lead. By providing 32 contacts and four lead ports—twice that of any other SCS system—the Precision Spectra System offers more coverage of the spinal cord for the management of chronic pain. Additional lead ports also give physicians more flexibility to treat their patients' pain at time of implant and more flexibility to adapt to changing pain patterns in the future.
Officials at Boston Scientific say they plan to invest and expand their offerings in neuromodulation and for the treatment of chronic pain in a big way. The Natick, Mass.-based company with about 5,000 Minnesota employees has recently begun other clinical trials and has launched several new products in Europe.
The Precision Spectra SCS System is currently under review by the U.S. Food and Drug Administration, and is not available for sale in the United States.
FDA, local med tech firms launch consortium
Posted by: James Walsh Updated: December 3, 2012 - 4:58 PMMedical device makers have ongoing concerns about the speed and transparency about the U.S. Food and Drug Administration’s approval process for new medical technology and therapy. But those concerns haven’t kept members of Minnesota’s medical device community from working with the FDA to improve the process.
On Monday, LifeScience Alley, the nation's largest state-based life science trade association, announced the formation of the Medical Device Innovation Consortium (MDIC), a public-private partnership with the FDA’s Center for Devices and Radiological Health (CDRH). The move formalizes plans by LifeScience Alley and CDRH to bring leaders of industry, academia and government agencies together to advance medical device regulatory science.
The consortium will be administered through a new non-profit organization and will be governed by a national board of directors, including industry executives and government leaders. Articles of Incorporation for the Consortium have been filed with the state of Minnesota, and the organization will be applying for a 501(c)(3) designation with the IRS.
Dr. Maura Donovan will serve as interim executive director. Donovan most recently served as vice president of therapy research and development at Medtronic. As interim executive director, she will lead the recruiting of the inaugural board of directors and build the consortium’s membership. She will also initiate the first subcommittees to identify and lead specific projects. Medtronic is supporting the project by loaning Donovan.
"Maura has provided excellent leadership to Medtronic over the years," said Rick Kuntz, M.D., senior vice president and Chief Scientific, Clinical and Regulatory Officer, Strategic & Scientific Operations at Medtronic. "Given the magnitude of the impact regulatory science can have on the creation and approval of safe and effective medical devices, we believe Maura is an excellent choice to lead this effort, and we are glad that we are able to support LifeScience Alley by lending Maura's time and expertise to the Consortium."
The Medical Device Innovation Consortium’s initial objectives focus on creating scientific tools to help develop and assess the safety and effectiveness of new medical devices. According to a statement, “the ultimate goals of the MDIC are to enhance the quality and performance of medical devices; improve the timeline of availability of these products to patients; and validate and qualify new methods, tools, approaches and standards in order to increase transparency and effectiveness for industry stakeholders.”
Dale Wahlstrom, CEO of LifeScience Alley, on Monday said: "The establishment of the Consortium is an impactful step in the advancement of medical device regulatory science. We have been working closely with Dr. Jeff Shuren, Dr. Michelle McMurry-Heath and CDRH staff over the past year to build a mechanism to solve pre-competitive technical issues. This is an exciting partnership that will have a profound impact across the nation's medical technology industry."
St. Jude gets CE Mark for new ICDs that protect against unnecessary shock
Posted by: James Walsh Updated: November 28, 2012 - 8:24 PMSt. Jude Medical on Monday announced European CE Mark approval of the Assura family of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). The Assura devices feature a technology that helps protect patients against inappropriate shocks.
Officials at St. Jude said that the new technology is projected to reduce inappropriate therapy by 74 percent. Products currently available in Europe include the Quadra Assura CRT-D, Unify Assura CRT-D and Fortify Assura ICD.
ICDs are implantable cardiac devices that treat abnormally fast, potentially lethal heart rhythms that can lead to sudden cardiac death if left untreated. A CRT-D device resynchronizes the beat of the heart’s lower chambers, which often beat out of sync in heart failure patients. A CRT-D also provides back up treatment for sudden cardiac death.
“With the three new discriminators and highest amount of delivered energy, the Assura devices provide the ideal combination of intelligence and strength. These devices offer unique features that I believe will help protect my patients from inappropriate shocks and provide greater defibrillation therapy assurance,” said Dr. Klaus-Jürgen Gutleben, Heart and Diabetes Center North Rhine-Westphalia in Bad Oeynhausen, Germany.
St. Jude Medical is a worldwide maker of medical technology headquartered in Little Canada.
More information about Assura can be found at: http://investors.sjm.com/phoenix.zhtml?c=73836&p=irol-newsArticle&ID=1762387&highlight=
St. Jude joins transcatheter aortic valve market
Posted by: James Walsh Updated: November 19, 2012 - 12:33 PMSt. Jude Medical on Monday announced the European approval of its Portico transcatheter aortic heart valve, which allows doctors to treat severe aortic stenosis for inoperable or high risk patients without open heart surgery.
With the announcement, St. Jude joins a growing roster of companies that are making a less-invasive way to treat what is a very dangerous disease. Aortic stenosis is a narrowing of the aortic heart valve that decreases blood flow from the heart. Before the advent of transcatheter aortic valve replacement (TAVR), the only way to replace a diseased aortic valve was through open heart surgery. Problem was, some patients are deemed too sick for open heart surgery to risk it.
But, without valve replacement, as many as half of those with severe aortic stenosis die within a year.
Transcatheter valve replacement allows doctors to insert a new valve into the heart by snaking a catheter up into the patient through an artery in the leg. Patients can be home from the hospital within a couple of days, instead of weeks after open heart surgery.
Currently, only Edwards Lifesciences, based in California, has the only transcatheter valve approved for sale in the United States. Medtronic is currently marketing its own TAVR product in Europe and expects to gain U.S. approval in 2014. Boson Scientific also is developing a similar product, which is expected to win European approval in late 2013.
St. Jude’s Portico valve can be resheathed and repositioned – or withdrawn – before it is released from its delivery system, allowing physicians more flexibility in placing the valve and preventing possible leakage around the valve, St. Jude said.
ADVERTISEMENT
recent posts
- Medtronic renal denervation trial continues to show positive results
- Boston Scientific launches new spinal cord stimulator in Europe
- FDA, local med tech firms launch consortium
- St. Jude gets CE Mark for new ICDs that protect against unnecessary shock
- St. Jude joins transcatheter aortic valve market
- Medtronic Foundation helps with Sandy aftermath
- St. Jude renal denervation study shows promise at six months
- Mahoney takes the reins at Boston Scientific
- MCTC, University of Minnesota forge biotechnology partnership
- Boston Scientific to Acquire Rhythmia Medical, Inc.
- Under the Scanner, Part Two
- Under the Scanner
- LifeScience Alley to host Biosciences Summit
- U of M's IEM Showcase coming Sept. 11
- Cryoballoon wins FDA and CE Mark approval
- Med Tech leaders and senators meet with FDA head
- DMD Conference seeking papers
- Medtronic announces U.S. launch of remote monitoring system
- Student teams win national biomedical design competition
ADVERTISEMENT
Links
inside the StarTribune
-
425 Portland Av. S.
Minneapolis, MN 55488
(612) 673-4000
- Company
- Subscriber Services
- Website
- Buy Ads
- Store
- Connect with Us
© 2013 StarTribune. All rights reserved.
StarTribune.com is powered by Limelight Networks
Newspaper Subscriptions
eEdition
RSS
Newsletters