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.
To encourage visibility about his company's cause, developing needed medical devices for children, the founder and CEO of DesignWise Medical decided to get on his feet and walk. On Thursday, Nov. 14, Brad Slaker walked 100 km, about 62 miles, to raise money and awareness. His Walk4Kids coincided with Give to the Max Day in Minnesota.
He started his walk at midnight in the Long Lake area and hit sidewalks and bike trails on his journey. His goal was to complete the walk in 24 hours. He visited local children's hospitals and other organizations that partner with DesignWise.
"I wanted this first walk to reflect the fact that many children with health needs and their families often feel alone with their struggles. I am starting this walk alone with little pre-publicity but with your support throughout the day and beyond we will together send the message that these children and families are not alone," Slaker said.
On Friday, Slaker sent out the following message:
"Whew! What a day. Thank you! We are humbled by your generosity! We raised $5,301.88, through 42 donors."
He finished his walk in 22 hours.
For more informaton about DesignWise, go to: http://www.designwisemedical.org
Got this from the folks at the University of Minnesota:
The Design of Medical Devices Conference to be held April 7-10, 2014, has extended the deadline for its call for papers. The conference seeks original, two-page papers that demonstrate new technologies and applications in medical device design. They invite submissions from academic and industry researchers, clinicians and practicioners.
Authors of accepted papers woll be invited to present at a scientific poster session held on Wednesday, April 9, at the DQ Room of TCF Bank Stadium. You must register and participate in the conference poster session to have your paper published.
Here is the publication schedule:
Nov. 19,l 2013 – 2-page technical brief due.
Dec. 30, 2013 – Notification of acceptance and revisions needed.
Jan. 27, 2014 – Permission to Publish form due.
Jan. 27, 2014 – Final 2-page technical briefs due.
For more information on the conference, which will be held at the Commons Hotel and McNamara Alumni Center, go to: www.dmd.umn.edu.
For more information about how to submit papers, go to the Call for Papers site.
This week, technology and business leaders praised a research collaboration between the University of Minnesota and medical technology company Boston Scientific with a 2013 Tekne Award.
Given by the Minnesota High Tech Association, the award celebrates "technological breakthroughs that improve the lives of Minnesotans and people around the world."
Boston Scientific became the university’s first collaborator in the Minnesota Innovative Partnerships (MN-IP) program, which allows companies to pay an upfront fee and receive an exclusive worldwide license to intellectual property resulting from sponsored research.
Jay Schrankler, executive director of the U’s Office for Technology Commercialization, said the award was positive feedback for MN-IP.
“It’s encouraging to see that our efforts to make the U more inviting for business are beginning to show real results,” Schrankler said. “Our partnership with Boston Scientific is resulting in exciting new medical technologies and innovative approaches to some of our society’s greatest healthcare challenges.”
According to the university, Boston Scientific and the U are now working on several projects to improve patients’ health through "cutting-edge medical solutions. Boston Scientific’s industry experience pairs up with the university’s world class talent and facilities, granting both parties access to resources normally out of reach."
For more information about MN-IP, go to: http://www.research.umn.edu/techcomm/industry-sponsor.html#.Un1Qkfmkqmw