A blog about what is new (and old) in the world of active implantable medical devices

Category Archives: Neural Stimulation

AIMDs for the stimulation of the nervous system

Boston Scientific Receives CE Mark of Vercise™ Deep Brain Stimulation System

Posted on by Posted in Boston Scientific, Brain Stimulation, Neural Stimulation, Parkinson's Disease
Boston Scientific Vercise DBS System www.implantable-device.com David Prutchi, Ph.D.

Image Credit: Boston Scientific

Boston Scientific Corporation received CE Mark approval for use of its Vercise™ Deep Brain Stimulation (DBS) System for the treatment of Parkinson’s disease. The Vercise DBS System is the first and only commercially available DBS system to incorporate multiple independent current control, which is designed to selectively stimulate targeted areas in the brain. This system is an innovative technology that is designed to provide physicians fine control of stimulation.

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St. Jude Medical Receives CE Mark Approval of Eon Mini to Treat Chronic Migraine

Posted on by Posted in Migraine, Neural Stimulation, Occipital Nerve Stimulation, St. Jude Medical

St Jude Medical Eon and Eon Mini Spinal Cord StimulatorsSt. Jude Medical announced it has received European CE Mark approval of its Eon™ family of neurostimulators for treating patients with intractable chronic migraine.

According to the press release:

“Intractable chronic migraine is one of the most difficult-to-treat headache disorders,” said Professor Gennaro Bussone, M.D., head of the Neurological Department at Istituto Besta in Milan Italy. “By definition, people living with this condition are spending half their month living with debilitating headaches. This therapy expands our options in helping manage patients who suffer with disabling chronic migraine symptoms.”

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Nevro Receives FDA Approval to Initiate Trial of its High-Frequency Spinal Cord Stimulation Therapy

Posted on by Posted in Nerve Blocking, Neural Stimulation, Nevro, Pain, Spinal Cord Stimulation
Nevro Senza Implantable Spinal Cord Stimulator for Back and Leg Pain

Image Source: Nevro's Website

Nevro Corp announced that FDA has granted approval for initiation of its SENZA-RCT study, a U.S. prospective, randomized, controlled pivotal clinical trial evaluating the safety and efficacy of Nevro’s high-frequency spinal cord stimulation system for the treatment of chronic pain.

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EnteroMedics Reports $123k Revenue from Sales of its Maestro RC IPG for Treatment of Obesity

Posted on by Posted in AIMD Business, EnteroMedics, Obesity, Vagus Nerve Stimulation

Today EnteroMedics recorded revenue for the first time since it was incorporated nearly eight years ago. The company reported revenue of about $123,000 in the first quarter of the year from the sale of its Maestro RC implantable vagus nerve stimulation system for treating obesity. Revenue was generated through sales by its distribution partner in Australia.

This is an important step for an implantable device company that faced very tough times in 2009 after its US clinical trial failed to meet a critical effectiveness goal.  EnteroMedics is currently conducting a pivotal trial that is expected to end in Q4 2012. EnteroMedics expects to file a premarket approval application with the FDA in the first half of 2013 if the data from the trial is positive.

 

 

Monash University in Australia Starts Test of Direct-to-Brain Visual Prosthesis Chips

Posted on by Posted in Blindness, Brain Stimulation, Electrode Materials, News, Tech Talk, Ultra-Low-Power ICs
Implantable chip for direct-to-brain visual prosthesis developed by Monash University. www.implantable-device.com

Image Credit: Monash Vision Group, Monash University, Australia

Engineers from the Monash Vision Group (MVG) have begun trialling the ASICs for a direct-to-brain visual prosthesis that is expected to enter human clinical trials in 2014.

The prosthesis will consist of a tiny camera mounted into a pair of glasses, which acts as the retina; a pocket processor, which takes the electronic information from the camera and converts it into signals enabling the brain to build up a visual construct; and cortical implants of several tiles which will be the portal for the stimulation of the visual cortex. Continue reading→

John Hopkins Researcher Develops New Early-Warning Seizures Detector with Low False-Positive Rate

Posted on by Posted in Brain Stimulation, Epilepsy, News, Tech Talk

Johns Hopkins’ Sridevi V. Sarma, an assistant professor of biomedical engineering, has devised new seizure detection software that, in early testing, significantly cuts the number of unneeded brain-stimulation therapy that an epilepsy patient would receive.

According to Sarma, “These devices use algorithms—a series of mathematical steps—to figure out when to administer the treatment,” Sarma said. “They’re very good at detecting when a seizure is about to happen, but they also produce lots of false positives, sometimes hundreds in one day. If you introduce electric current to the brain too often, we don’t know what the health impacts might be. Also, too many false alarms can shorten the life of the battery that powers the device, which must be replaced surgically.” Continue reading→

Neuromed’s TIME Battery- and RF-Powered Totally Implantable Multichannel Spinal Cord Stimulator (ca. 1988)

Posted on by Posted in Advanced Neuromodulation Systems (ANS), Brain Stimulation, Epilepsy, History, Museum, Neuromed (1980-1995), Pain, Parkinson's Disease, Spinal Cord Stimulation, St. Jude Medical, Wireless Power Transmission
Neuromed dual-power multichannel neurostimulator 1988

Neuromed TIME IPG on loan from Daniel Villamil's collection.

Neuromed was formed in 1980 with an initial capitalization of $150,000 by Bill Borkan through money obtained when Borkan`s parents took out a second mortgage on their home. Borkan’s desire to help his sister, Jennie, a cerebral palsy patient, got him started in neurostimulation technology. In the next few years, Neuromed developed and marketed a RF-powered implantable spinal cord stimulator, along with its external radio frequency transmitter.

Throughout the 1980s, development of more advanced devices was ongoing at Neuromed. My friend Daniel Villamil from CCC Medical has in his collection one of these more modern units, which he lent to me for photographing. The “Total Implantable Multichannel Electronics” (TIME) spinal cord stimulator shown in this picture went into clinical trials around 1988. This was a device that was internally powered by its own battery. However, it could also be RF-powered after the eventual battery failure. Continue reading→

St. Jude’s (ANS) Rechargeable Spinal Cord Stimulators Eon and Eon Mini

Posted on by Posted in Advanced Neuromodulation Systems (ANS), Pain, Spinal Cord Stimulation, St. Jude Medical, Tech Talk, Wireless Power Transmission

St Jude Medical Eon and Eon Mini Spinal Cord Stimulators

In 2005, St. Jude Medical purchased Advanced Neuromodulation Systems (ANS) in Plano, Texas.  ANS had developed a number of spinal cord stimulation IPGs that were either externally powered via inductive link, internally powered by a primary cell, or internally powered by a transcutaneously rechargeable lithium-ion cell.

Today, the most popular St. Jude spinal cord stimulators are the rechargeable 42 cc Eon and 18 cc Eon mini neurostimulators.

They are constant-current devices with a rated longevity of 10 years. Current through up to 16 electrodes is programmable between 0-25.5 mA with a pulse width of 50-500 µs and a frequency between 2-1200 Hz. Continue reading→

St. Jude’s DBS Study Confirms Benefit of Constant Current System for Parkinson’s Disease

Posted on by Posted in Brain Stimulation, Parkinson's Disease, St. Jude Medical
SJM Libra and Libra XP deep-brain neurostimulators to treat Parkinson's disease
Image Credit: St. Jude Medical

Today St. Jude announced that its first controlled study of Deep Brain Stimulation (DBS) confirms benefit of constant current system for patients with Parkinson’s Disease.

Results were published online today by The Lancet Neurology journal. The aim of the study was to evaluate the Libra(TM) and LibraXP(TM) DBS constant current systems to determine the devices’ safety and effectiveness in managing the symptoms of PD. Continue reading→

Biotectix

Posted on by Posted in Biotectix, Brain Stimulation, Cardiac Pacing, Electrode Materials, Electrodes, Tech Talk
Biotectix electrically conductive polymers for implantable devices
Image Credit: Biotectix

Biotectix of Ann Arbor, MI recently contacted me to let me know of new conductive polymer materials that they are developing to enhance the performance of next-gen implantable stimulation and sensing devices.

Indeed, their materials sound very promising.  According to Biotectix, their electrode coatings and device components are made from proprietary conducting polymers that provide intimate, long-term electrical and biological connections between implantable electrodes and the target tissue.  They offer the conductivity and stability of metals at a low-cost with the ease of processing and biological functionality of polymers. Continue reading→

NDI Medical’s Miniature MicroPulse Neurostimulator

Posted on by Posted in Incontinence, Medtronic, Muscular Stimulation, NDI Medical, Pain, Paralysis, Spinal Cord Stimulation, SPR Therapeutics, Wireless Power Transmission
NDI Medical MicroPulse rechargeable neurostimulator
Image Credit: SPR Therapeutics

NDI Medical was founded in 2002 by Geoffrey B. Thrope to develop and commercialize neurodevice products.  NDI Medical developed the MicroPulse neurostimulator, a thumb-sized, rechargeable pulse generator, that has been used for the treatment of incontinence and pain, as well as an implantable device for the restoration of function of paralyzed limbs.

According to a 2006 news release by the electronics assembly manufacturer for the MicroPulse:

“Using minimally-invasive surgery, the Micropulse is implanted into a patient, usually in the lower abdomen or buttock, where the device is most comfortable and least visible. After implantation, a clinician uses a wireless programmer to set the Micropulse’s stimulus parameter and timing patterns. The programmer, as well as the patient’s controller for the device, has a range of about three feet.

To recharge the device’s lithium-ion battery, the patient applies a recharging patch for several hours to the vicinity of the implant. The battery needs recharging from once a month to every few weeks.” Continue reading→

Leptos Biomedical’s Splanchnic Nerve Stimulation For Treatment Of Obesity (2002-2010)

Posted on by Posted in EnteroMedics, Gastric Stimulation, History, Leptos Biomedical, Neural Stimulation, Obesity

Leptos Biomedical, Inc. Splanchnic nerve stimulation for treatment of obesityLeptos Biomedical was founded in Fridley, MN in 2002 by Dr. John D. Dobak.   Leptos intended to develop an implantable device to stimulate the greater splanchnic nerve, that was hoped would  result in reduced food intake and increased energy expenditure.

In February 2010 Leptos announced its closure.  Reasons were not provided, but it has been suggested that the decision was prompted by the 2009 announcement by competitor EnteroMedics’ that it had failed to meet the primary goals of its pivotal study. EnteroMedics’ Maestro device didn’t perform any better than a sham device.  EnteroMedics is now conducting a new study with the device.

Click here for Leptos Biomedical’s patents.

 

Neuros Medical’s Implantable Device to Alleviate Amputation Pain

Posted on by Posted in Nerve Blocking, Neuros Medical, Pain
Neuros Medical Electrical Nerve Block implantable device to alleviate amputated limb pain
Image Credit: Neuros Medical

Neuros Medical was founded by Jon J. Snyder in Cleveland, OH in 2008 to develop a neurostimulation therapy to alleviate chronic pain.  The company’s Electrical Nerve Block™ technology is based on research done at Case Western Reserve University.

The company’s Nerve Block is an implantable device that delivers high-frequency stimulation to sensory nerves in the peripheral nervous system. Neuros’ aim is to stop a wide variety of chronic pain, including residual limb pain, chronic post surgical pain, and chronic migraine.

In November 2011 Neuros Medical announced that it has received IDE approval from the FDA to evaluate its technology for use in acute treatment of pain in the residual limb of amputees.

Company website: http://www.neurosmedical.com/

Click here for patents on Case Western University’s nerve blocking technology

 

 

Spinal Modulation’s Neurostimulator for the Stimulation of the Dorsal Root Ganglion

Posted on by Posted in Mir A Imran (InCube), Pain, Spinal Cord Stimulation, Spinal Modulation
Spinal modulation for stimulation of dorsal root ganglion
Image Credit: Spinal Modulation

 

Spinal Modulation was founded by Mir Imran in Menlo Park, CA in 2004.  The company has developed an implantable neurostimulator to deliver signals to the primary sensory neurons located within the dorsal root ganglion (DRG).  The idea is that unlike dorsal column spinal cord stimulation, the Spinal Modulation system breaks the pain signal’s path before it enters the spinal cord. Continue reading→