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Watch your back: chronic back pain is front and center in recent FDA approvals.

If you're reading this, it's statistically highly likely that you will have a personal interest in treatment for back pain--according to the American Chiropractic Association (ACA), a full 50 percent of working Americans experience back pain symptoms every year. And those are only the reported cases. The ACA also reports that back pain is one of the most common reasons for missed work, and is the second most common reason for visits to the doctor's office, outnumbered only by upper-respiratory infections. Most cases of back pain are mechanical or non-organic--meaning they are not caused by serious conditions, such as inflammatory arthritis, infection, fracture or cancer. What's more, Americans spend at least $50 billion each year on back pain--more if indirect costs such as those for missed work are taken into consideration. Experts estimate that as many as 80 percent of the population will experience a back problem at some time in their lives.

So, back pain is very much a part of our collective consciousness. The National Pain Report recently characterized the spinal cord stimulation (SCS) market as "crowded," which is not surprising when the current projections for market growth are so high. According to a recent Daedel Research report, SCS is the most commonly used implantable neurostimulation technology for management of pain syndromes. The technology works by delivering a low-voltage electrical current continuously to the spinal cord to block the sensation of pain. Market growth in this sector is driven by the-now familiar factors of an aging population, rising healthcare expenditure per capita, increasing cases of obesity and the growing number of failed surgeries, Daedel Research reports.

Nevro Corp. is one of several companies that recently received U.S. Food and Drug Administration (FDA) approval for an SCS system. Nevro is a specialized company, focusing only on SCS technology for the treatment of chronic pain. However, its Senza platform faces stiff competition from medtech giants such as Medtronic plc, Boston Scientific Corp. and St. Jude Medical Inc., the latter of which also earned an SCS approval from the FDA this year (see below). According to iData Research, the SCS market was worth $1.3 billion last year, but less than 10 percent of people who could benefit from the technology use it. Therefore, predictions for the SCS market place its value at close to $7 billion by 2020 because of its great growth potential.

Senza Spinal Cord Stimulation System Gets FDA Nod

Menlo Park, Calif.-based Nevro Corp., a medical device company that makes solutions for the treatment of chronic pain, has received approval from the FDA for its Senza spinal cord stimulation system.

The Senza SCS system, which delivers Nevro's proprietary HF10 therapy, is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.

The Senza system delivering HF10 therapy has been on the market in Europe and Australia over the past five years. HF10 is designed to deliver pain relief without paresthesia (a constant tingling sensation that is the basis of traditional SCS) and can be used without patient restrictions on motor vehicle operation. The Senza system, which is implantable, is permitted by the FDA for use in an MRI (magnetic resonance imaging) scan at 3 Tesla strength.

The Senza system was the subject of the Senza-RCT pivotal study, the first to directly compare SCS therapies. The multicenter study was conducted across 11 U.S. clinical trial sites, comparing the safety and effectiveness of HF10 therapy to traditional SCS therapy. The study enrolled 241 patients.

"My fellow investigators and I have eagerly awaited the approval of the Senza SCS system," said Leonardo Kapural, M.D., Ph.D., lead investigator for the Senza-RCT pivotal study from Wake Forest University Baptist Medical Center, Winston-Salem, N.C. "The results of the study showed that HF10 therapy provides better pain relief and nearly twice the response rate of traditional SCS, representing a tangible advance in chronic pain management. HF10 therapy will allow me to help more patients in my practice by addressing back pain in addition to leg pain. And, with HF10 therapy I can for the first time focus on providing pain relief to my patients instead of managing paresthesia, which is a paradigm shift for my pain practice."

"We are grateful to the inspiring dedication of the clinical investigators, their study coordinators, and patients involved in the Senza-RCT study, as they collectively have paved the way for this therapy to help those suffering from debilitating chronic pain," said Michael DeMane, chairman and CEO of Nevro. "The Nevro organization is prepared to initiate a responsible rollout of HF10 therapy to the U.S. pain management community and the patients they serve to ensure we deliver the clinical outcomes that are the foundation of our therapy and company."

St. Jude Medical's Protege MRI SCS Device Also Passes Regulatory Muster

St. Jude Medical Inc. received FDA approval of its Protege MRI spinal cord stimulation system and for MRI compatibility of the company's 60 centimeter Octrode percutaneous leads, which has received magnetic resonance (MR)-conditional labeling for use with the Protege system.

The Protege MRI system is the smallest MR-conditional spinal cord stimulation implantable pulse generator (IPG) available in the United States, and the only upgradeable IPG on the market to allow patients to safely undergo head and extremity magnetic resonance imaging (MRI) scans, St. Jude executives claim. Upgradeable technology allows patients to access future SCS technology from St. Jude Medical, once approved, through software updates rather than surgical device replacement. Historically, most patients would need additional surgery to receive new product features and benefits.

"The launch of the Protege MRI system provides physicians with a solution that offers the benefits of future therapy upgrades as they are approved without the need for a future surgery," said Robert Levy, M.D., Ph.D., director of the Marcus Neuroscience Institute in Boca Raton, Fla. "The Protege MRI system is a technology advancement that optimizes chronic pain care without compromising a patient's potential need for future head and extremity MRI scans."

Chronic pain affects more than 100 million Americans, an incidence rate which outpaces heart disease, cancer and diabetes combined. In total, the condition costs the American population 515 million workdays annually and generates upwards of 40 million visits to physicians each year, according to St. Jude Medical.

SCS therapy can offer proven, meaningful chronic pain relief for many patients while improving the quality of life and reducing or even eliminating a patient's use of pain medication. Yet for some patients battling chronic pain, the possible need for future MRI scans has acted as a barrier to SCS therapy.

"With the approval of the Protege MRI system, St. Jude Medical has helped remove a barrier for some patients who may benefit from SCS therapy, while preserving the ability of those patients to access future technology and therapy advancements wirelessly through upgradeable technology," said Eric S. Fain, M.D., group president of St. Jude Medical. "Going forward, patients implanted with a Protege MRI system will not only have the ability to access future upgrades, but will also have the ability to undergo head and extremity MRI scans."

In addition to the approval of the Protege MRI system, St. Jude Medical also plans to seek updated labeling in key markets around the world for several existing products, including its flagship Penta paddle lead, to give more patients the ability to safely undergo MRI scans. St. Jude Medical also plans to submit testing data supporting full-body MRI-conditional scan labeling for future SCS systems.

Spinal cord stimulation is a therapy used to manage chronic pain. SCS therapy uses a small implanted generator to deliver electrical pulses to the nerve libers of the spinal column via thin wires, known as leads, with electrodes. These electrical pulses mask or interrupt pain signals as they travel up the spinal cord to the brain, reducing the sensation of pain.

Based in St. Paul, Minn., St. Jude Medical is a global medical device manufacturer focusing on cardiac rhythm management, atrial fibrillation, cardiovascular disease and neuromodulation.
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Title Annotation:New Technology Update
Author:Arrowsmith, Ranica
Publication:Orthopedic Design & Technology
Date:May 1, 2015
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