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

SecondSight Starts US Commercial Implants of Argus II Retinal Prosthesis

Posted on by Posted in Blindness, Retinal Stimulation, retinitis pigmentosa, Second Sight

Second Sight Argus II Retinal Prosthesis www.implantable-device.com David Prutchi PhD

On Jan 29, 2014, Second Sight Medical announced that it had performed the first commercial implants of the Argus II visual prosthetic at the University of Michigan’s Kellogg Eye Center.  Second Sight plans to provide updates during a press conference at the American Society of Cataract and Refractive Surgery conference in April, after the patients complete about three months of rehabilitation and training. The retinal implant, approved by the FDA in 2013, is designed to enhance vision in patients who have been progressively blinded by the condition retinitis pigmentosa.

 

EnteroMedics Reports Maestro Obesity Study Showing 25% Reduction in Excess Weight

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

EnteroMedics Maestro Obesity IPG David Prutchi PhD

EnteroMedics reported new clinical trial data for its Maestro system, which is designed to treat obesity through vagus nerve stimulation. The company said that its Maestro RC system lost 25% of their excess weight, or 10% of their total body weight, after 18 months. Patients who received a sham implant lost 12% of excess weight, or 4% of their total weight. The company is running a five-year study of the system.  The system is approved in Europe and Australia, but not the U.S.

 

 

Boston Scientific Reports Good Results with Precision Spectra™ SCS

Posted on by Posted in Boston Scientific, Pain, Spinal Cord Stimulation

Precision Spectra Spinal Cord Stimulator by Boston Scientific www.implantable-device.com David Prutchi, Ph.D.

Retrospective data for Boston Scientific’s Precision Spectra™ Spinal Cord Stimulator (SCS) System were presented at the North American Neuromodulation Society (NANS) 17th annual meeting in Las Vegas. The data show that the device provided highly significant pain relief three months after implantation.

According to the press release:

Precision Spectra is the first SCS System designed to improve pain relief using the innovative and highly advanced Illumina 3D Software, a three dimensional anatomy-driven computer model. By providing 32 contacts – twice the number of contacts available with other SCS systems – the Precision Spectra System offers more coverage of the spinal cord for the management of chronic pain.

The retrospective study of up to 213 consecutive patients at 13 centers focused on patients with chronic pain who were treated with the Precision Spectra SCS System. Results include:

A 94 percent SCS trial therapy success rate (n=213)

A highly significant reduction in pain from an average baseline score of 7.8, on a 10-point scale, to an average score of 3.2 at three months post implant (in the patients who have reached the three-month follow up, n=113)

A highly significant reduction in low back pain from an average baseline score of 7.0, on a 10-point scale, to an average of 2.9 at three months post implant (in the low back pain patients who have reached the three-month follow up, n=32)

Early results indicate improvements in function, including walking and sleeping, in addition to reductions in opioid use and disability

Medtronic Implants Activa® PC+S DBS IPG in US

Posted on by Posted in Alzheimer's, Brain Stimulation, Medtronic, OCD, Parkinson's Disease

Activa PC+S deep brain stimulator with sensing and recording of brain activity David Prutchi PhD www.implantable-device.com

Medtronic today announced the first US implant of the novel Activa® PC+S deep brain stimulation (DBS) system that, for the first time, enables the sensing and recording of select brain activity while simultaneously providing targeted DBS therapy.

According to the press release:

MINNEAPOLIS – December 5, 2013 – Medtronic, Inc. (NYSE: MDT) today announced the first U.S. implants of a novel deep brain stimulation (DBS) system in research that may one day transform the treatment of devastating neurological and psychological disorders, such as Parkinson’s disease, essential tremor, dystonia, and treatment-resistant obsessive-compulsive disorder.

The Activa® PC+S DBS system delivers Medtronic DBS therapy while simultaneously sensing and recording electrical signals in key areas of the brain, using sensing technology and an adjustable stimulation algorithm. This system, which is not approved by the Food and Drug Administration for commercial use in the United States and is available to select physicians for investigational use only, may offer researchers revolutionary insights into how neurological conditions develop and progress, as well as the brain’s specific responses to Medtronic DBS therapy. Additionally, the system may provide future possibilities for creating personalized DBS therapy across a range of conditions.

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St. Jude Studies Combined PNFS and SCS for Chronic Low Back and Leg Pain

Posted on by Posted in Pain, PNS, Spinal Cord Stimulation, St. Jude Medical

St Jude Medical Eon and Eon Mini Spinal Cord Stimulators

St. Jude announced today that it has launched the SENSE™ Subcutaneous and Epidural Neuromodulation System Evaluation study – a clinical study to evaluate the combination of peripheral nerve field stimulation (PNfS), and spinal cord stimulation (SCS), to determine whether the two therapies together offer more effective management of chronic low back and leg pain than SCS alone.

According to the press release:

Peripheral nerve field stimulation and SCS are minimally-invasive neurostimulation therapies that involve the implant of a stimulation device and small electrical leads. In SCS, leads are placed in the epidural space to interrupt or mask the transmission of pain signals to the brain. In PNfS, leads are placed just under the skin in the subcutaneous tissue to stimulate the network of peripheral nerve fibers in order to reduce the pain at the location where it is most severe. PNfS is not the same as peripheral nerve stimulation (PNS), which targets a specific nerve. Instead, PNfS targets a more general network of nerves.

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St. Jude Launches SUNBURST Study to Evaluate New Prodigy Neurostimulator’s Burst Stimulation for Chronic Pain

Posted on by Posted in Pain, Spinal Cord Stimulation, St. Jude Medical

St Jude Prodigy Neurostimulator Burst David Prutchi PhD www.implantable-device.comSt. Jude announced today that it has initiated a clinical study of the Prodigy™ neurostimulator, which is the first SCS system able to deliver a proprietary mode of stimulation therapy called burst stimulation.

The purpose of the SUNBURST™ (Success Using Neuromodulation with BURST) study is to evaluate whether burst stimulation can be more effective in managing chronic pain than traditional tonic stimulation.

According to the press release:

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Cerbomed’s Non-Invasive Vagus Nerve Stimulator Poses Challenge to Implantable VNS Systems

Posted on by Posted in Cerbomed, Cyberonics, Depression, Epilepsy, Inflammation, Pain, Vagus Nerve Stimulation

Cerbomed tVNS non invasive vagus nerve stimulator

Cerbomed GmbH, located in Erlangen, Germany, was founded in 2005 to develop transcutaneous Vagus Nerve Stimulation (t-VNS®) neuromodulation systems.

Surgically accessing the Vagus Nerve is not trivial, and implanting a VNS system involving cuff electrodes is risky and recovery is lengthy.  Enter t-VNS, which is delivered non-invasively to the auricular branch of the vagus nerve (ABVN), making it an attractive therapy option when compared to implantable vagus nerve stimulators.

The NEMOS tVNS system consists of a handheld stimulator and a dedicated ear electrode, which patients wear like an earphone.  According to Cerbomed, intensity, pulse duration and frequency of the t-VNS stimulation have been optimized to induce signals in thick-myelinated Aβ fibres of the ABVN. Like those of the cervical branch of the vagus nerve, these project directly to the nucleus of the solitary tract (NTS) in the brainstem.

In 2010 Cerbomed received the CE mark for its NEMOS® transcutaneous Vagus Nerve Stimulator for the treatment of epilepsy and depression. In 2012, the indication was expanded to include the treatment of pain.

In September 2012, Cerbomed entered into a strategic partnership with Cyberonics, Inc., the global market leader in vagus nerve stimulation.  Cyberonics made an initial investment of €2 million to fund Cerbomed’s epilepsy clinical trial in Germany, with further investments of up to €5.5 million, subject to the achievement of certain clinical milestones. Cyberonics is a minority shareholder with certain rights, including representation on Cerbomed’s advisory board and an exclusive option for worldwide sales and distribution of NEMOS.

 

European Heart Rhythm Association Issues Very Interesting Report on New Devices for the Treatment of Heart Failure

Posted on by Posted in BioControl, Cardiac Pacing, Cardiac Stimulation (other), CardioMEMS, CVRx, Heart Failure (CHF), Impulse Dynamics, Spinal Cord Stimulation, Vagus Nerve Stimulation

Implantable devices for the treatment of heart failure, David Prutchi, PhD

 

A position paper was published yesterday by the European Heart Rhythm Association reporting on the performance of new devices for the treatment of heart failure (HF). The report has been endorsed by the Heart Failure Association.

The abstract for the paper titled “New devices in heart failure: an European Heart Rhythm Association report” reads:

 Several new devices for the treatment of heart failure (HF) patients have been introduced and are increasingly used in clinical practice or are under clinical evaluation in either observational and/or randomized clinical trials. These devices include cardiac contractility modulation, spinal cord stimulation, carotid sinus nerve stimulation, cervical vagal stimulation, intracardiac atrioventricular nodal vagal stimulation, and implantable hemodynamic monitoring devices. This task force believes that an overview on these technologies is important. Special focus is given to patients with HF New York Heart Association Classes III and IV and narrow QRS complex, who represent the largest group in HF compared with patients with wide QRS complex. An overview on potential device options in addition to optimal medical therapy will be helpful for all physicians treating HF patients.

The report places special focus to patients with HF New York Heart Association (NYHA) Classes III and IV and narrow QRS complex, who represent the largest group in HF compared with patients with wide QRS complex (who are candidates for treatment with cardiac resynchronization therapy – CRT).

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NanoWattICs Establishes Working Relationship with Rosellini Scientific to Develop Suite of Neurostimulation Devices

Posted on by Posted in Nanowattics, Neural Stimulation, Nexeon MedSystems, Rosellini Scientific, Ultra-Low-Power ICs

Nanowattics logo custom IC ASIC design for implantable medical devices

ASIC designer NanoWattICs (Uruguay) and Rosellini Scientific (Dallas, TX) have announced they have entered into a collaborative relationship for the development of a suite of neurostimulation devices comprising implantable, wireless and non-invasive technologies.  From the press release:

Rosellini Scientific, LLC (“Rosellini Scientific”; Dallas, TX, USA) and NanoWattICs SRL (“NanoWattICs”; Montevideo, UY) are pleased to formally announce their collaborative working relationship. For the past twelve months, NanoWattICs has provided support for the engineering efforts required by portfolio companies belonging to Rosellini Scientific.

Rosellini Scientific and NanoWattICs share common developmental interests and possess complementary strengths and expertise, which has produced a fruitful collaboration to date. The continuation of this long-term alliance will allow NanoWattICs to continue growing its team while participating in the development of innovative medical technologies guided by Rosellini Scientific.

“NanoWattICs are world-class engineers striving to develop the next generation of innovative medical technologies,” said Austin Duke, Director of Emerging Therapies at Rosellini Scientific. “We believe that combining their engineering expertise with the Rosellini Scientific vision will greatly enhance the process of bringing high-quality, life-changing medical technologies to the global market.”

“We are extremely pleased and excited about this collaboration opportunity with Rosellini Scientific. The combined knowledge of the two teams can hardly be matched by other players of our size in the industry,” said Pablo Aguirre, Director and Co-Founder of NanoWattICs. “We look forward to expanding our team and together bringing to market the next generation of medical devices.”

Currently, Rosellini Scientific and NanoWattICs are developing a suite of neurostimulation devices comprising implantable, wireless and non-invasive technologies. This work is being supported in part by a recently awarded grant funded by Agencia Nacional de Investigación e Innovación (ANII) in Uruguay. The devices are being developed for a variety of clinical indications, including cardiac arrhythmias, migraines and neuropathic pain.

Previously, NanoWattICs provided engineering support for Rosellini Scientific to assist in the development of a non-invasive medical imaging system (Spectral MD Inc.) and wireless telemetry capabilities for a novel glaucoma implant (collaborative development with ISTAR Medical SA).

UPDATE Jan 19, 2017:  Rosellini Scientific merged with Nexeon MedSystems

Medtronic Reports CRM AIMD Sales Trend Showing Stabilization + Strong Earnings from Neuromodulation AIMDs

Posted on by Posted in AIMD Business, Bradycardia, Brain Stimulation, Medtronic, Pain, Spinal Cord Stimulation, Tachycardia

Medtronic_LogoMedtronic released today its earning reports for the second quarter of fiscal year 2014, which ended October 25, 2013.

Medtronic states in the press release: “Second quarter revenue from Implantable Cardioverter Defibrillators (ICDs) was $713 million, an increase of 4 percent on a constant currency basis in a market that continues to show a trend toward stabilization. Pacing revenue was $477 million, an increase of 2 percent on a constant currency basis.”

On related news from the release: “Neuromodulation revenue of $479 million increased 6 percent on both a constant currency and an as reported basis. Growth was driven by strong performance from Activa® deep brain stimulation systems, as well as the launch of the RestoreSensor® SureScan® MRI spinal cord stimulator in the United States.”

NeuroPace Receives FDA PMA Approval for for the RNS System to Treat Refractory Partial Epilepsy

Posted on by Posted in Brain Stimulation, Dr. David R. Fischell, Dr. Robert Fischell, Epilepsy, NeuroPace

Image Credit: NeuroPace

NeuroPace is a privately-held company in Mountain View, CA. Their RNS® implantable stimulator, along with depth leads and cortical strip leads are designed for the treatment of medically refractory partial epilepsy.

On November 14, 2013, NeuroPace has now received FDA pre-market approval for the NeuroPace RNS System as a treatment for adults with partial onset seizures that have not been controlled with two or more antiepileptic drugs.

According to the press release:

The RNS System has been evaluated in three clinical trials, including a prospective, randomized, double-blinded, sham stimulation controlled pivotal study. The pivotal study primary effectiveness endpoint was met by demonstrating a 37.9 percent reduction in seizure frequency in patients treated with responsive stimulation compared to a 17.3 percent reduction in patients who were implanted with the device but were not receiving responsive stimulation during a three month blinded period. The difference is statistically significant (p=0.012). For those subjects who reached two years post-implant, 55% of the subjects experienced a 50% or greater reduction in seizures.

Unlike Cyberonics’ VNS IPGs, the RNS neurostimulator is designed to detect abnormal electrical activity in the brain and respond by delivering electrical stimulation to normalize brain activity before the patient experiences seizure symptoms. The neurostimulator is implanted in the cranium and connected to one or two leads that are implanted near the patient’s seizure focus.

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WISE s.r.l. Raises €1M to Develop Flexible Electrodes for Spinal Cord Stimulation

Posted on by Posted in Electrode Materials, Spinal Cord Stimulation

Supersonic Cluster Beam ImplantationWISE (Wiringless Implantable Stretchable Electronics), a Milan- and Berlin-based medical device companyraised a seed-round of € 1 M to advance the development of its first product aimed at the spinal cord stimulation market.

WISE’s technology relies on Supersonic Cluster Beam Implantation (SCBI) for the metallization of polymers and elastomers. SCBI allows to fabricate complex microelectronic circuits and interconnects on stretchable and conformable supports that preserve their electrical performances after extensive cycles of stretching and bending of the substrates. The devices can be efficiently fabricated on biocompatible platforms, and are therefore suitable for the production of implantable biomedical devices.

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Nyxoah Developing Implant for Obstructive Sleep Apnea and Snoring

Posted on by Posted in Neural Stimulation, Obstructive Sleep Apnea

Nyxoah patch obstructive sleep apnea David Prutchi PhD www.implantable-device.com

Nyxoah was founded in 2009 by Robert Taub and Dr. Adi Mashiach to develop neurostimulation treatments focused for Obstructive Sleep Apnea.

Nyxoah is currently engaged in clinical tests of a tiny, battery-less implantable neurostimulator that can electrically control the nerves of the tongue and so prevent airway blockage.

According to Nyxoah, the implantable device is 20mm high and 2.5mm wide (although it looks more like 20mm diameter x 2.5mm thick to me…). It’s designed to be implanted close to the nerves of the tongue muscle by a single small incision in a procedure that reportedly takes only 15 minutes.

The implant is powered and controlled by a disposable external adhesive patch.  Every evening the OSA sufferer uses a new disposable patch that has been powered by the charger. The patch, measuring only 55 x 90 mm, is attached to the skin under the chin and has enough power to wirelessly activate the implant for a full night sleep session.

Nyxoah patch obstructive sleep apnea David Prutchi PhD www.implantable-device.com

 

 

 

Neuros Medical Receives IDE Approval to Conduct Pivotal Study

Posted on by Posted in Nerve Blocking, Neuros Medical, Pain

Neuros Medical Altius www.implantable-device.com David Prutchi PhDNeuros Medical received an Investigational Device Exemption to conduct a pivotal clinical trial to evaluate the Altius™ System High Frequency Nerve Block technology for the management of intractable limb pain of amputees.   The prospective, randomized, controlled pivotal clinical trial will consist of 130 patients at 15 institutions in the U.S. to evaluate the safety and efficacy of Neuros Medical’s Altius System.

 

MicroTransponder Raises Funds for Clinical Trials of Serenity VNS IPG for Treating Tinnitus

Posted on by Posted in Micro Transponder, Tinnitus, Vagus Nerve Stimulation

MicroTransponder Serenity IPG for treatment of Tinnitus David Prutchi PhD www.implantable-device.com

MicroTransponder, Inc. of Dallas, TX has raised $3.4 million to carry out clinical trials of its Vivistim System to help restore functionality in the upper limbs of stroke patients, and its Serenity System designed to “rewire” the auditory cortex of tinnitus patients. The company intends to secure a CE mark for both systems next year, and then raise more funds to support a clinical trial for a pre-market approval in the U.S.

According to the company’s website, the Serenity System™ pairs Vagus Nerve Stimulation (VNS) with listening to tones. VNS is approved by the FDA and has been used to treat over 60,000 patients for epilepsy and depression, but has not yet been evaluated for safety or efficacy to treat tinnitus.  The device is fully implantable and can easily be used at home. During the therapy, an individual sits in a comfortable chair and wear headphones. They listen to tones while receiving small bursts of neurostimulation, which activate the vagus nerve.  UT Dallas says that “preclinical tests demonstrated that this approach “rewires” damaged brain circuitry associated with tinnitus, potentially yielding long-term reversal of symptoms. The initial human trial in Belgium provided encouraging results.”

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