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.
On Tuesday, St. Jude Medical announced a clinical study to look at burst stimulation as a potentially more effective –and tingle-free – way to manage chronic pain.
On Wednesday, the Little Canada-based medical technology company said it's launching another study regarding spinal cord stimulation – this one looking at whether combining SCS with peripheral nerve field stimulation (PNfs) offers more effective management of chronic low back and leg pain.
Peripheral nerve field stimulation and spinal cord stimulation involve implanting a stimulation device and small electrical wires, called leads. For spinal cord stimulation, the wires are places along the spine to block pain signals to the brain. For PNfS, wires are placed just under the skin in the subcutaneous tissue to stimulate the network of peripheral nerve fibers in order to reduce the pain at the location where it is most severe. PNfS is not the same as peripheral nerve stimulation (PNS), which targets a specific nerve. Instead, PNfS targets a more general network of nerves.
“We often see patients who have had multiple back surgeries to alleviate their debilitating chronic pain. Ultimately, many of these surgeries fail, leaving patients to seek other options like neurostimulation therapy,” said Dr. Porter McRoberts, an interventional pain physician at Holy Cross Orthopedic Institute in Fort Lauderdale, Fla., and the principal investigator in the study. “Peripheral nerve field stimulation therapy, targeting local nerves near the painful area, combined with traditional spinal cord stimulation, targeting the central nervous system, has the potential to improve our ability to effectively manage patients with difficult-to-treat low back pain.”
The SENSE trial is a randomized, prospective, multicenter, clinical study to demonstrate the safety and effectiveness of PNfS used in combination with spinal cord stimulation to manage low back pain and leg pain. The study will also look at whether the treatment is cost-effective. Up to 450 patients will be enrolled at up to 35 sites in the United States.
To qualify for the study, participants must have chronic low back and leg pain as a result of Failed Back Surgery Syndrome, a condition that refers to patients with back pain or leg pain despite lumbar surgery.
“Traditional spinal cord stimulation therapy has been used to manage chronic pain for more than 40 years and it works very well for many pain conditions,” said Dr. Mark D. Carlson, chief medical officer and vice president of global clinical affairs for St. Jude Medical. “Peripheral nerve field stimulation as an adjunct therapy has the potential to improve outcomes for those who struggle with severe chronic low back and leg pain.”
Neurostimulation, the use of electric stimulation to control chronic pain, continues to gain steam in the U.S. and abroad. On Tuesday, St. Jude Medical announced that it has started a clinical study of its Prodigy neurostimulator, a spinal cord stimulation system that delivers something called burst stimulation. It is the first of its kind, St. Jude said.
The SUNBURST (Success Using Neuromodulation with BURST) study will evaluate whether burst stimulation can be more effective in managing chronic pain than traditional tonic stimulation that sends a continuous stream of electricity.
Spinal cord stimulation to manage pain has been around for more than 40 years. Implantable systems came into being as batteries became smaller and longer-lasting. The procedure involves implanting thin wires along the spinal cord. The wires are connected to a small pulse generator, similar to a pacemaker, that is usually implanted just beneath the skin. The generator delivers low levels of electrical energy to interrupt or mask the transmission of pain signals to the brain.
Patients with a traditional spinal cord stimulator feel the mild pulses of energy as a tingling sensation called paresthesia. St. Jude says that early research indicates that burst stimulation may be able to deliver therapy with little or no tingling and that it may be more effective than traditional stimulation treatment. It may even be more effective in managing complex back pain.
“Severe chronic pain has a debilitating effect on patients’ lives,” said Dr. Timothy Deer, an interventional pain physician, and president and chief executive officer of the Center for Pain Relief in Charleston, WV. “Burst stimulation may provide us with a comprehensive approach to managing patients whose pain is not adequately controlled with tonic spinal cord stimulation alone, or for those who lose therapeutic benefit over time. Importantly, we hope to demonstrate that burst stimulation produces paresthesia-free pain relief which may make it ideal for those who can’t tolerate traditional stimulation.”
The SUNBURST study will examine the safety and effectiveness of the Prodigy neurostimulation system that uses both traditional stimulation and burst stimulation therapy to manage patients with chronic intractable pain. A maximum of 442 patients will be enrolled at up to 50 sites in the U.S.
The Prodigy neurostimulator is not yet approved for use in the U.S.
Boston Scientific’s Vercise Deep Brain Stimulation (DBS) System has received CE Mark approval for the treatment of intractable primary and secondary dystonia, a neurological movement disorder characterized by involuntary muscle contractions, the company reported Tuesday.
Dystonia affects more than 500,000 people across Europe. It is the third most common movement disorder after Parkinson's disease and essential tremor. Symptoms include involuntary muscle contractions, which can be painful and debilitating. Boston Scientific says the Vercise DBS System is the first system designed to selectively stimulate targeted areas of the brain in order to customize therapy and manage symptoms of Parkinson's disease. This system now offers treatment for patients with dystonia.
"Historically, treatment of secondary dystonia has been challenging and efficacy was typically incomplete and partially limited by side effects. The Vercise DBS system represents an advancement in dystonia care by providing more flexible and unique programming options for targeted deep brain stimulation tailored to each individual," said Prof. Dr. Andrea Kühn.
For more information, go to: http://www.bostonscientific.com
St. Teresa Medical, a medical-device startup from Maple Grove, competes tonight in the final round of "Get in the Ring: The American Startup Clash." Folks can watch the stream at 7 p.m. Central Time and cast votes for their favorite startup at www.Kauffman.org/GITR.
The company is commercializing a new technology called FASTCLOT that stops bleeding more quickly and has less potential for adverse side effects than current products, according to company officials.
FASTCLOT combines a fiber dressing “delivery system” with two human-derived clot-forming proteins. When applied, the dressing rapidly dissolves and speeds the formation of a clot over a bleeding injury. It is also quickly absorbed. Other such products are either applied as a patch or with a syringe, making them less user-friendly for the surgeon, St. Teresa said. The product can be used in surgical, trauma, dental, veterinary, military and consumer applications.
The company has conducted 12 pre-clinical studies. Two FASTCLOT products are being used on dogs and horses with “excellent results,” officials said. The company anticipates European regulatory approval for human use in mid-2014 and in the United States in early 2016.
St. Teresa Medical was founded 2010. The company is one of eight organizations from seven states facing off in the final round tonight. The Ewing Marion Kauffman Foundation is hosting the first-ever U.S. competition and will live stream the competition for the title of America’s most promising entrepreneur.
A cash prize of $10,000 will be awarded to the top U.S. finisher; $5,000 will go to the runner-up. Online viewers will be able to vote for the "audience favorite" via a special URL to be announced during the event.
In addition to the cash prize, the startup named U.S. champion will travel the next day to the Nov. 22 Get in the Ring global finals in Rotterdam, the Netherlands. That entrepreneur will face seven other international finalists, selected from 30 participating nations, for a chance to secure angel investment from a potential pool of €1,000,000, or approximately $1.3 million.
The U.S. finalists were selected from 283 applicants from around the country. They are:
Drazil Foods, Edina, Minn.
EyeVerify, Kansas City, Kan.
MANA Nutrition, Matthews, N.C.
POPVOX, Redwood City, Calif.
St. Teresa Medical, Inc., Maple Grove.
Travefy, Lincoln, Neb.
weeSpring, New York
Get in the Ring was founded in 2009 by the Erasmus Centre for Entrepreneurship in the Netherlands to bring the world's most promising entrepreneurs together with those who can help them succeed and to inspire others to start their entrepreneurial journeys. The international finals are held each November during Global Entrepreneurship Week.
Medtronic announced on Thursday that a German court has ordered the discontinuation of a prior court ruling that prohibited the Fridley-based company from marketing or selling its CoreValve transcatheter aortic valve replacement system in Germany.
Medtronic had been prohibited from selling CoreValve in Germany since August 26, after a lower German court ruled that Medtronic infringed on a patent by Edwards Lifesciences. Edwards also makes a transcatheter aortic valve.
But, on Thursday, a higher German court ruled that, because of a preliminary opinion by the European Patent Office that Edwards’ patent claims are not valid, it could not assume that the Edwards patent is valid. Essentially, the higher court decided to discontinue enforcing the earlier patent infringement ruling.
“Medtronic is very pleased with this decision as it will ensure that patients in Germany who need aortic valve replacement will have access to this life-saving therapy,” said John Liddicoat, M.D., senior vice president, Medtronic, and president of the Medtronic Structural Heart Business. “As a result of the ruling, Medtronic will resume distribution of the CoreValve System in Germany.”
Medtronic said it will post a required bond as soon as possible and resume sales in Germany.
CoreValve is not yet commercially available in the United States. Medtronic officials expect CoreValve to win U.S. regulatory approval sometime in 2014. Edwards’ Sapien transcatheter aortic valve is currently the only such valve approved for use in the U.S., and only for patients considered extreme risk for open heart surgery.
Last month, Boston Scientific announced European approval of its Lotus transcatheter valve. Last year, St. Jude hit the European market with its Portico valve.
Transcatheter aortic 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 or through an incision in the upper body. It is a much less invasive procedure than open heart surgery and patients can be home from the hospital within a couple of days, instead of weeks after the procedure.