AIMDs for the stimulation of the nervous system
SetPoint Medical, headquartered in Valencia, California, is developing neuromodulation therapies for patients with inflammatory autoimmune diseases, such as rheumatoid arthritis (RA), inflammatory bowel disease (IBD), psoriasis, diabetes, heart disease, and multiple sclerosis. SetPoint’s proprietary neuromodulation platform consists of an implantable “microregulator”, wireless charger and iPad prescription pad application.
Toronto-based Functional Neuromodulation announced that it implanted the first U.S. Alzheimer’s patient in the “ADvance Study” with a deep brain stimulation (DBS) system meant to improve cognitive performance. ADvance will evaluate the safety and potential clinical benefit of DBS of the fornix (DBS-f), a major inflow and output pathway in the brain’s memory circuit, for patients with mild Alzheimer’s. The ADvance Study is being conducted using Medtronic Activa DBS IPGs.
While DBS has been an effective treatment for movement disorders for more than 15 years, it was only recently that this approach was first applied to Alzheimer’s. Dr. Andres Lozano, a neurosurgeon at University of Toronto and Scientific Founder of Functional Neuromodulation, originated the concept of treating memory disorders using deep brain stimulation (DBS) while treating a patient suffering from morbid obesity. In this patient, DBS stimulation of the hypothalamus and fornix was associated with an unexpected observed improvement in the patient’s memory.
Boston Scientific Received European Regulatory Approval For New Precision Spectra™ Spinal Cord Stimulator System. It is the first and so-far only SCS system with 32 contacts and 32 dedicated power sources designed to provide pain relief to a broad spectrum of chronic pain patients.
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.
Bionic Vision Australia researchers announced on August 30, 2012 that they successfully performed the first implantation of an early prototype bionic eye with 24 electrodes.
According to the press release:
St. 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.”
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.
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.
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
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 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
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
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 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 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