AT THE FOREFRONT OF MENDING THE BRAIN

Size: px

Start display at page:

Download "AT THE FOREFRONT OF MENDING THE BRAIN"

Joella Jacobs
5 years ago
Views:

1 AT THE FOREFRONT OF MENDING THE BRAIN Abbott's neuromodulation portfolio fuels earnings growth while offering lifechanging treatment Many people who are dealt with a diagnosis of Parkinson's disease or essential tremor search for a way to limit symptoms and side effects to make living easier. Abbott's Infinity Deep Brain Stimulation system provides relief of symptoms such as tremor and rigidity that allows people to use an Apple ipod controller to manage their therapy. Building on its neuromodulation advancements, Abbott offers the DBS system uses an implanted device with wires leading to the brain. Similar to a pacemaker, the therapy sends electrical stimulation signals to areas in the brain that cause involuntary movements and can help to effectively calm Parkinson's symptoms. The Infinity DBS therapy with its familiar Apple ios controller is another innovative technology within Abbott's neuromodulation portfolio, one of its fastest-growing business units for the health technology company. With neuromodulation revenue growing as much as 50 percent in recent quarters and a robust pipeline of new offerings coming closer to the marketplace, it's another piece of Abbott's accelerated revenue growth that's projected to outperform its recent strong financial performance. Along with groundbreaking technology to help Parkinson's, the Infinity DBS therapy is the only one 1 that uses a wireless ios device (an Apple ipod) to control stimulation. That feature allows patients to receive discreet, personalized treatment in the palm of their hand. The handheld programmer allows John to control how much or how little stimulation he needs, another breakthrough to empower patients with their own care. Global leader in chronic pain treatment Movement disorder devices fall under Abbott s neuromodulation business, where the company has taken a leadership role in a medical area that is being buoyed by an aging population around the world. Abbott holds the largest U.S. and global market share for implantable chronic pain neurostimulation devices. 2 The market's potential remains strong: Global Market Insights puts the total neurostimulation device market at $16 billion by People with chronic pain are often eager to find non-drug alternatives to manage their symptoms to avoid potentially addictive prescription medications. Neurostimulation therapies from Abbott offer drug-free relief that in many cases can put control of the treatment in the hands of those using devices through an Apple ipod controller. Spinal cord stimulation (SCS) is among several highlights of Abbott's neuromodulation business. The company's proprietary waveform BurstDR stimulation has been clinically proven to offer superior pain relief over traditional SCS therapy and is preferred by more than 81 percent of patients over traditional spinal cord therapies. 3 BurstDR received approval in October 2016 after 10 years of research to perfect the treatment that emulates natural firing patterns in the brain to modulate the sensory and emotional pathways to enable people to focus on their lives and not on their chronic pain. Another high-growth neuromodulation area is dorsal root ganglion (DRG) stimulation, with Abbott's Proclaim series of implantable devices that can, as with the DBS system, be controlled with a handheld ios device. The DRG solution is designed for cases where traditional SCS options for treating chronic intractable pain aren't appropriate for patients with Chronic Regional Pain Syndrome in the lower limbs.

2 The DRG a spinal structure densely populated with sensory nerves plays a critical role in the development and maintenance of chronic pain. The DRG's unique pain processes and its anatomical considerations make it an ideal interventional target to treat various pain conditions. 4 Like many parts of Abbott s businesses, the neuromodulation lineup aligns well with healthcare trends and an aging population that seeks life-changing ways to manage their symptoms. "We see this as a great growth opportunity as well, and one that you want to continue to invest behind," said Brian Yoor, Abbott s chief financial officer. "We're making a real difference in people's lives in terms of pain management. We're engineering some amazing ways that people can end their reliance on potentially addictive pain medication, and our science is at the very forefront of treating Parkinson's and other chronic conditions." References 1. St. Jude Medical. Memo #SJM-INF (Based on competitors' earning reports and Abbott's internal company estimates). 3. Deer T, Slavin KV, Amirdelfan K, et al. Success Using Neuromodulation With BURST (SUNBURST) Study: Results From a Prospective, Randomized Controlled Trial Using a Novel Burst Waveform. Neuromodulation Deer, TR, Levy, RM, Kramer, J, et al. (2017). Dorsal root ganglion stimulation yielded higher treatment success rate for complex regional pain syndrome and causalgia at 3 and 12 months: a randomized comparative trial. Pain. 158(4): ACCURATE IDE STUDY, St. Jude Medical. (n=152). Brief Summary:As with any surgery or therapy, deep brain stimulation has risks and complications. Most side effects of DBS surgery are temporary and correct themselves over time. Some people may experience lasting, stroke-like symptoms, such as weakness, numbness, problems with vision or slurred speech. In the event that the side effects are intolerable or you are not satisfied with the therapy, the DBS system can be turned off or surgically removed. Risks of brain surgery include serious complications such as coma, bleeding inside the brain, paralysis, seizures and infection. Some of these may be fatal. Indications for Use: US: Bilateral stimulation of the subthalamic nucleus (STN) as an adjunctive therapy to reduce some of the symptoms of advanced levodopa-responsive Parkinson's disease that are not adequately controlled by medications, and unilateral or bilateral stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the suppression of disabling upper extremity tremor in adult essential tremor patients whose tremor is not adequately controlled by medications and where the tremor constitutes a significant functional disability. International: Unilateral or bilateral stimulation of the thalamus, internal globus pallidus (GPi), or subthalamic nucleus (STN) in patients with levodopa-responsive Parkinson ' disease, unilateral or bilateral stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the management of tremor, and unilateral or bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) for the management of intractable, chronic dystonia, including primary and secondary dystonia. Contraindications: Patients who are unable to operate the system or for whom test stimulation is unsuccessful. Diathermy, electroshock therapy, and transcranial magnetic stimulation (TMS) are contraindicated for patients with a deep brain stimulation system. Warnings/Precautions:Return of symptoms due to abrupt cessation of stimulation (rebound effect), excessive or low frequency stimulation, risk of depression and suicide, implanted cardiac systems or other active implantable devices, magnetic resonance imaging (MRI), electromagnetic interference (EMI), proximity to electrosurgery devices and highoutput ultrasonics and lithotripsy, ultrasonic scanning equipment, external defibrillators, and therapeutic radiation, therapeutic magnets, radiofrequency sources, explosive or flammable gases, theft detectors and metal screening devices, activities requiring excessive twisting or stretching, operation of machinery and equipment, pregnancy, and case damage. Patients who are poor surgical risks, with multiple illnesses, or with active general infections should not be implanted. Adverse Effects: Loss of therapeutic benefit or decreased therapeutic response, painful stimulation, persistent pain around the implanted parts (e.g. along the extension path in the neck), worsening of motor impairment, paresis, dystonia, sensory disturbance or impairment, speech or language impairment, and cognitive impairment. Surgical

3 risks include intracranial hemorrhage, stroke, paralysis, and death. Other complications may include seizures and infection. Clinician s manual must be reviewed for detailed disclosure.brief Summary: As with any surgery or therapy, deep brain stimulation has risks and complications. Most side effects of DBS surgery are temporary and correct themselves over time. Some people may experience lasting, stroke-like symptoms, such as weakness, numbness, problems with vision or slurred speech. In the event that the side effects are intolerable or you are not satisfied with the therapy, the DBS system can be turned off or surgically removed. Risks of brain surgery include serious complications such as coma, bleeding inside the brain, paralysis, seizures and infection. Some of these may be fatal. indications for Use: US: Bilateral stimulation of the subthalamic nucleus (STN) as an adjunctive therapy to reduce some of the symptoms of advanced levodopa-responsive Parkinson's disease that are not adequately controlled by medications, and unilateral or bilateral stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the suppression of disabling upper extremity tremor in adult essential tremor patients whose tremor is not adequately controlled by medications and where the tremor constitutes a significant functional disability. International: Unilateral or bilateral stimulation of the thalamus, internal globus pallidus (GPi), or subthalamic nucleus (STN) in patients with levodopa-responsive Parkinson ' disease, unilateral or bilateral stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the management of tremor, and unilateral or bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) for the management of intractable, chronic dystonia, including primary and secondary dystonia. Contraindications: Patients who are unable to operate the system or for whom test stimulation is unsuccessful. Diathermy, electroshock therapy, and transcranial magnetic stimulation (TMS) are contraindicated for patients with a deep brain stimulation system. warnings/precautions: Return of symptoms due to abrupt cessation of stimulation (rebound effect), excessive or low frequency stimulation, risk of depression and suicide, implanted cardiac systems or other active implantable devices, magnetic resonance imaging (MRI), electromagnetic interference (EMI), proximity to electrosurgery devices and high-output ultrasonics and lithotripsy, ultrasonic scanning equipment, external defibrillators, and therapeutic radiation, therapeutic magnets, radiofrequency sources, explosive or flammable gases, theft detectors and metal screening devices, activities requiring excessive twisting or stretching, operation of machinery and equipment, pregnancy, and case damage. Patients who are poor surgical risks, with multiple illnesses, or with active general infections should not be implanted. adverse Effects: Loss of therapeutic benefit or decreased therapeutic response, painful stimulation, persistent pain around the implanted parts (e.g. along the extension path in the neck), worsening of motor impairment, paresis, dystonia, sensory disturbance or impairment, speech or language impairment, and cognitive impairment. Surgical risks include intracranial hemorrhage, stroke, paralysis, and death. Other complications may include seizures and infection. Clinician s manual must be reviewed for detailed disclosure. Brief Summary:Prior to using these devices, please review the User's Guide for a complete listing of indications, contraindications, warnings, precautions, potential adverse events, and directions for use. The system is intended to be used with leads and associated extensions that are compatible with the system. Indications for Use:Spinal cord stimulation as an aid in the management of chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome and intractable low back and leg pain. Contraindications:Patients who are unable to operate the system or who have failed to receive effective pain relief during trial stimulation. Warnings/Precautions:Diathermy therapy, implanted cardiac systems, magnetic resonance imaging (MRI), explosive or flammable gases, theft detectors and metal screening devices, lead movement, operation of machinery and equipment, postural changes, pediatric use, pregnancy, and case damage. Patients who are poor surgical risks, with multiple illnesses, or with active general infections should not be implanted. Adverse Effects: Painful stimulation, loss of pain relief, surgical risks (e.g., paralysis). User s Guide must be reviewed for detailed disclosure.brief Summary: Prior to using these devices, please review the User's Guide for a complete listing of indications, contraindications, warnings, precautions, potential adverse events, and

4 directions for use. The system is intended to be used with leads and associated extensions that are compatible with the system. indications for Use: Spinal cord stimulation as an aid in the management of chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome and intractable low back and leg pain. contraindications: Patients who are unable to operate the system or who have failed to receive effective pain relief during trial stimulation. warnings/precautions: Diathermy therapy, implanted cardiac systems, magnetic resonance imaging (MRI), explosive or flammable gases, theft detectors and metal screening devices, lead movement, operation of machinery and equipment, postural changes, pediatric use, pregnancy, and case damage. Patients who are poor surgical risks, with multiple illnesses, or with active general infections should not be implanted. adverse Effects: Painful stimulation, loss of pain relief, surgical risks (e.g., paralysis). User s Guide must be reviewed for detailed disclosure. Brief Summary:Prior to using these devices, please review the User's Manual for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use. Indications for Use:Spinal column stimulation via epidural and intra-spinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable* pain of the lower limbs in adult patients with Complex Regional Pain Syndrome (CRPS) types I and II.** *Study subjects from the ACCURATE clinical study had failed to achieve adequate pain relief from at least two prior pharmacologic treatments from at least two different drug classes and continued their pharmacologic therapy during the clinical study. **Please note that in 1994, a consensus group of pain medicine experts gathered by the International Association for the Study of Pain (IASP) reviewed diagnostic criteria and agreed to rename reflex sympathetic dystrophy (RSD) and causalgia, as complex regional pain syndrome (CRPS) types I and II, respectively. Contraindications:Patients who are unable to operate the system, who are poor surgical risks, or who have failed to receive effective pain relief during trial stimulation. Warnings/Precautions:Diathermy therapy, implanted cardiac systems or other active implantable devices, magnetic resonance imaging (MRI), computed tomography (CT), electrosurgery devices, ultrasonic scanning equipment, therapeutic radiation, explosive or flammable gases, theft detectors and metal screening devices, lead movement, operation of machinery and equipment, pediatric use, pregnancy, and case damage. Adverse Effects: Painful stimulation, loss of pain relief, surgical risks (e.g., paralysis). Implant Manual must be reviewed for detailed disclosure. Refer to the User's Manual for detailed indications, contraindications, warnings, precautions and potential adverse events.brief Summary: Prior to using these devices, please review the User's Manual for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use. indications for Use: Spinal column stimulation via epidural and intra-spinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable* pain of the lower limbs in adult patients with Complex Regional Pain Syndrome (CRPS) types I and II.** *Study subjects from the ACCURATE clinical study had failed to achieve adequate pain relief from at least two prior pharmacologic treatments from at least two different drug classes and continued their pharmacologic therapy during the clinical study. **Please note that in 1994, a consensus group of pain medicine experts gathered by the International Association for the Study of Pain (IASP) reviewed diagnostic criteria and agreed to rename reflex sympathetic dystrophy (RSD) and causalgia, as complex regional pain syndrome (CRPS) types I and II, respectively. contraindications: Patients who are unable to operate the system, who are poor surgical risks, or who have failed to receive effective pain relief during trial stimulation. warnings/precautions: Diathermy therapy, implanted cardiac systems or other active implantable devices, magnetic resonance imaging (MRI), computed tomography (CT), electrosurgery devices, ultrasonic scanning equipment, therapeutic radiation, explosive or flammable gases, theft detectors and metal screening devices, lead movement, operation of machinery and equipment, pediatric use, pregnancy, and case damage.

5 adverse Effects: Painful stimulation, loss of pain relief, surgical risks (e.g., paralysis). Implant Manual must be reviewed for detailed disclosure. Refer to the User's Manual for detailed indications, contraindications, warnings, precautions and potential adverse events.

PATIENT CONTROLLER ST. JUDE MEDICAL UNDERSTANDING IMPORTANT FEATURES ON YOUR

PATIENT CONTROLLER ST. JUDE MEDICAL UNDERSTANDING IMPORTANT FEATURES ON YOUR UNDERSTANDING IMPORTANT FEATURES ON YOUR ST. JUDE MEDICAL PATIENT CONTROLLER THINGS TO KNOW BEFORE AND AFTER AN MRI OR SURGICAL PROCEDURE WHEN YOU HAVE A ST. JUDE MEDICAL PROCLAIM NEUROSTIMULATION SYSTEM