Now that we are nearly a month into 2013, it’s time to reset our horizon scanning efforts and prepare ourselves for the year ahead. Last year was exciting for the neurosciences community. Several artificial discs and stroke devices were approved by the FDA, the debate about the efficacy of spine surgery continued, and new criteria for comprehensive stroke center certification was released.
It’s easy to imagine that 2013 will come with a host of new technological and programmatic developments across the year. To help understand the evolving product pipeline in neurosciences and spine, I've outlined what we believe are the top six technological trends to watch for across 2013.
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1. Artificial cervical discs and motion sparing technologies for spine
Prior to 2012, only three cervical discs had FDA approval and adoption was lukewarm at best. However, in September and October of 2012, the FDA granted premarket approval (PMA) for the SECURE-C (Globus Medical) and the PCM (NuVasive). This technology wave is expected to continue into 2013 as two more cervical discs are in the near-term FDA PMA queue: the Mobi-C (LDR Spine Inc), which is the first disc indicated for two-level cervical disc arthroplasty, and the Kineflex C (SpinalMotion Inc).
The industry is poised to see further market expansion, especially because the most recent clinical data has shown improved outcomes and reduced complications or follow-up surgery with cervical discs compared to traditional fusion. BioMedGPS’ SmartTRAK Spine Module estimates that the U.S. cervical disc market will grow from $122 million to $231 million between 2012 and 2016.
In October 2012, the FDA approved a new motion preserving intralaminar stabilization device, the coflex (Paradigm) as an alternative to pedicle screw fixation of the lumbar spine. The coflex is only the second FDA approved intraspinous device, along with the X-Stop (Medtronic). More technologies are expected to receive approval in the coming years. The Flexus (Globus), In-Space (DePuy Synthes), and Superior (VertiFlex) all include motion sparing technologies in various stages of the FDA premarket approval process and are likely to see movement this year.
As the spine device market grows larger and financial pressure from payers continue to question back surgery, it will be important for hospitals to maintain strict technology management in order to maintain margins.
2. DBS for epilepsy
Deep Brain Stimulation (DBS) is a therapeutic treatment in which a pacemaker-like device in the chest sends electrical stimulation to leads implanted in targeted areas of the brain. FDA-approved for Parkinson’s disease, essential tremor, and dystonia, DBS is a key differentiator for premier movement disorder programs.
The neuroscience community is waiting for the FDA to expand DBS’s approval to include treatment for epileptic patients. An FDA panel denied an application for expansion in 2010, though DBS is already approved to treat epilepsy in Europe and Canada. Recently, a clinical trial found that DBS reduced seizures in epilepsy patients over a five year period, with seizure reduction and quality of life measures continuing to improve over time. Neuroscience leaders are hopeful that these results will bring the FDA closer to approving DBS for epilepsy.
DBS will provide epilepsy programs an alternative to vagal nerve stimulation to treat surgical patients. While DBS is a much more invasive procedure, these surgical cases can bring significant revenue to epilepsy programs.
3. Interventional stroke and brain aneurysm devices
The stroke industry saw expanded technology offerings and new criteria for comprehensive center certification released by the Joint Commission in 2012. The number of FDA approved mechanical thrombectomy devices doubled in 2012 with the approval of the Solitaire FR (Covidien) and the Trevo Pro (Stryker). Both employ new stent-based clot retrieval technology. This market is expected to grow as physicians look to expand the treatment window for stroke from 4.5 hours with tPA to up to 8 hours with clot retrieval devices. At least 6 other companies are developing clot retrieval devices such as the Revive SE (J&J) and the Lazarus ReCover (Lazarus effect), both of which are CE marked in Europe.
Endovascular aneurysm treatment is poised to innovate it's treatment with new flow-diverting stents, representing a paradigm shift away from aneurysm coiling. Cleveland Clinic estimates that over the next five years, approximately one-fourth of worldwide aneurysm treatment procedures could be eligible for treatment with stents. The Pipeline Embolization Device (Covidien) is the only FDA approved flow-diverter, but others are in clinical trials or have already received CE mark approval include the SILK Arterial Reconstruction Device (Balt Extrusion), Luna Aneurysm Embolization System (Nfocus Neuromedical), WEB Aneurysm Embolization System (Sequent Medical Inc), and the Cardiatis Multilayer Stent (Cardiatis SA).
With an expanding product pipeline and growing interest in certification, managing investments across stroke services will continue to pose a challenge. Our research teams hope to help programs understand what turns the dial with our custom Stroke Program Gap Analysis.
4. Neuromodulation device use for headaches
Cluster headaches impact 1% of the U.S. population. They occur at the same time every day and continue for weeks, with no known cause or effective treatment. A new therapy for cluster headaches involves an almond-sized neuromodulation device that stimulates the sphenopalatine ganglion (SPG) nerve bundle, located behind the bridge of the nose.
This patient-controlled stimulator is implanted in the upper gum through a minimally invasive incision, with the lead tip implanted on the SPG nerve bundle on the side of the face where headache pain is typically experienced. Once the patient feels a headache starting, a remote control is used to stimulate the SPG nerve and block the pain in 10 minutes.
European clinical trials found that 68% of participants experienced relief in cluster headache pain and frequency. Already approved in Europe, the device is under investigation in the U.S. Neuromodulation devices are currently being evaluated through research for a variety of applications, including chronic pain, obesity, headaches, and degenerative eye disease.
5. Sinus therapy
Chronic sinusitis affects 32 million people annually, resulting in over 18.3 million physician visits per year. Antibiotics represent a first line of therapy for sinusitis patients, but these are often ineffective. Balloon sinuplasty treatment has begun to gain favor with physicians.
This is a minimally invasive treatment for sinusitis. A catheter is threaded through the sinus anatomy and a balloon is inflated to gently open the nasal cavities. Acclarent’s Balloon Sinuplasty device and Entellus’ FinEss offer alternatives to traditional open functional endoscopic sinus surgery. It’s likely these devices will be increasingly employed as patients present more complex cases.
6. Stem cell therapy for neurodegenerative therapies
Around seven million people are currently living with a neurodegenerative disease such as Parkinson’s, Alzheimer’s, Huntington’s, ALS, or spinal muscular atrophy. Presently, NIH research spends roughly $770 million annually studying these conditions, but there are no effective therapies to date.
One promising area of research includes advancements in stem cells. Stem cells are capable of self-renewal and can differentiate in multiple types of cells in the body. Cellular therapies for neurodegenerative diseases replace lost neurons and involve the derivation of the specific neuron types lost in disease. Additional clinical trials will occur over the next few years, and studies hope to bridge the gap between preclinical research and clinical applications.
Stay in Touch in 2013
Technology Insights will continue to keep you updated on the evolving neurosciences frontier at The Pipeline. We will share new research focused specifically on programmatic struggles in our upcoming webconference addressing the neuroscience physician shortage. Register today.