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

Increase in Temperature from AIMDs Dissipating Endogenous Heat

Posted on by Posted in Impulse Dynamics, MetaCure, My Portfolio, Rechargeable Batteries, Wireless Power Transmission

Analysis of Temperature Increase at the Device/Tissue Interface for Implantable Medical Devices Dissipating Endogenous HeatActive Implantable Medical Devices generate heat as a result of resistive losses in their circuitry, exothermic reaction in their batteries, eddy-current heating due to inductive recharge, friction between mechanical components, etc.  The European Standard which regulates AIMDs limits the heating of the outer surface of an AIMD to 2ºC above normal body temperature.  Despite the rapid growth in the use of AIMDs, the relationship between AIMD endogenous heat generation and tissue temperature has not been quantified.   In the attached paper we aimed at determining the limit of endogenous heat that can be dissipated in-vivo by the surface area of an AIMD to remain compliant with the 2ºC temperature increase limit.  In our study, four Sinclair mini-pigs underwent implantation of AIMD simulants instrumented to dissipate heat and measure temperature internally, as well as the device/tissue interface temperature.

We found that for a device with the surface area and geometry that we used, approximately 1W can be dissipated before reaching the 2ºC temperature increase limit. 

Click here for a preprint of this paper

 

ElectroCore’s Noninvasive Vagus Nerve Stimulation – An Interesting Challenge to Implantable VNS Systems

Posted on by Posted in Asthma, COPD, Migraine, Vagus Nerve Stimulation

ElectroCore noninvasive VNS www.implantable-device.com David Prutchi PhD

Surgically accessing the Vagus Nerve is not trivial, and implanting a VNS system involving cuff electrodes is risky and recovery is lengthy.  Enter ElectroCore Medical of Bernards Township, New Jersey – it is developing non-invasive VNS therapies that treat or prevent symptoms of serious headache conditions, including migraines and cluster headaches, and bronchoconstriction including asthma and chronic obstructive pulmonary disorder (COPD).

Its gammaCore® therapy is applied using a hand-held, non-invasive neurostimulator device, and is used to treat primary headaches in adults, including migraine, cluster headache, and medication overuse headache. According to ElectroCore, “gammaCore relies on the activation of afferent A-fibers in the vagus nerve which is not implicated in negative cardiac or respiratory effects.”  Results from studies of the therapy as both an acute and preventative against these headache types have been promising, and are ongoing around the world.

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Interesting 2012 Presentation by Setpoint Medical on Neuromodulation for Treating Chronic Inflammatory Diseases

Posted on by Posted in Inflammation, Neural Stimulation, SetPoint Medical, Vagus Nerve Stimulation

Setpoint Medical www.implantable-device.com David Prutchi PhD

I found online the PowerPoint presentation for: R Zitnik, Y Levine, M Faltys, T Arnold, “Harnessing the Inflammatory Reflex: Using Neuromodulation as a Novel Approach to Treat Chronic Inflammatory Diseases”, North American Neuromodulation Society Meeting 2012.

The presentation shows some preliminary animal results, presents an artist’s conception of the implantable system, and concludes as follows:

“- Inflammatory diseases are a $30B market with significant unmet need

– Using neuromodulation to drive the inflammatory reflex has a sound biological foundation: Use in clinic is supported by strong preclinical evidence

– This is the first demonstration that an implantable neuromodulation device improves clinical manifestations of RA:

  • Significant and clinically meaningful improvement in signs and symptoms
  • Response rates were comparable to those with current biologic agents
  • Further larger controlled studies in RA and other chronic inflammatory diseases are warranted.
  • Our microregulator offers significant advantages over current vagal nerve stimulation devices

SetPoint intends to offer a novel therapy that will significantly increases patient QOL, while bending per-patient cost curves down by more than 60%”

 

 

 

Cyberonics Reports 12.4% Increase in VNS Sales for Fiscal Q1 2014

Posted on by Posted in AIMD Business, Cyberonics, Epilepsy, Vagus Nerve Stimulation

Cyberonics VNS IPGs www.implantable-device.com David Prutchi PhDNet product sales increased 12.4% to $67.4 million in the first fiscal quarter ended July 26 for Cyberonics, Inc. of Houston, TX. Including license revenue, sales were up 14.2% overall, with Europe in particular contributing a strong performance. Diluted earnings per share were adjusted by $0.17 cents due to a litigation settlement.

According to the Aug. 22, 2013 press release, “operating results for the first quarter of fiscal 2014 compared to the first quarter of fiscal 2013, and other achievements, include:

  • Net product sales of $67.4 million, an increase of 12.4%;
  • Net sales of $68.9 million (including $1.5 million of license revenue), an increase of 14.2%;
  • Worldwide unit sales of 3,354, an increase of 9.8%;
  • Record U.S. net product sales of $56.4 million, an increase of 10.8%;
  • Strong International unit sales of 899, an increase of 20.8%;
  • Adjusted non-GAAP income from operations increased by 21.9% to $21.0 million and adjusted non-GAAP income per diluted share increased by 27.9% to $0.48;¹
  • Share repurchases of $13 million; and
  • Significant progress in three clinical studies, E-36, E-37, and ANTHEM.”

 

Autonomic Technologies’ Sphenopalatine Ganglion Stimulator Treats Cluster Headaches

Posted on by Posted in Autonomic Technologies, Cluster Headaches, Migraine, Sphenopalatine Ganglion Stimulation

ATI SPG Neurostimulator for Cluster Headache and Migraine www.implantable-device.com David Prutchi PhD

Autonomic Technologies, Inc. (ATI) is a medical device company located in the San Francisco Bay Area focused on the development of neurostimulators for the treatment of severe headache. The company’s initial product, the ATI Neurostimulation System, is approved in Europe for the treatment of cluster headache and is currently being investigated in a multi-center, randomized study for the treatment of high frequency, high disability migraine.

The ATI Neurostimulation System is a rechargeable, multi-channel, peripheral nerve stimulation system. The System includes:

  • The ATI Neurostimulator: A miniaturized neurostimulator (smaller than an almond) with an integral lead designed to fit ranging facial anatomy.
  • The Remote Controller: A hand-held device with simple therapy controls that provides on-demand patient-controlled SPG therapy. Therapy settings are individualized and can be adjusted quickly by physicians using a programmer laptop.

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Cleveland FES Center’s Networked Neural Prosthesis

Posted on by Posted in Brain-Computer Interface, Cleveland FES Center, Muscular Stimulation, Paralysis, Spinal Cord Injury (SCI)

Cleveland FES - Networked Neural Prosthesis (NNP) system, www.implantable-device.com, David Prutchi, Ph.D.

The Cleveland FES Center was established in 1991 as a consortium between the Cleveland VA Medical Center (CVAMC), the private educational institution of Case Western Reserve University (CWRU), and the public hospital system of MetroHealth Medical Center (MHMC).

As part of this consortium, Dr. Hunter Peckham – biomedical engineering professor at Case Western Reserve University – and his group have developed the Networked Neuroprosthetic System (NNPS), which is based on a network of small implanted modules they call “neuroprosthetic building blocks”.  These modules are distributed throughout the body, and each is dedicated to a specific function.  Modules are linked to a centralized power source via a network cable through which they also communicate with each other.

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SetPoint Medical Secures $27M to Develop VNS Device to Treat Inflammatory Diseases

Posted on by Posted in Boston Scientific, Inflammation, SetPoint Medical, Vagus Nerve Stimulation

SetPoint Medical implantable device for rheumatoid arthritis and Crohn's Disease

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.

SetPoint announced today that it has secured $27 million in financing from its current investors along with new investors Covidien Ventures, Action Potential Venture Capital Limited, the new GlaxoSmithKline (GSK) strategic venture capital fund for bioelectronic medicines and technologies, and Boston Scientific. The proceeds of the financing will be used to expand ongoing clinical development of the SetPoint bioelectronics therapy approach in rheumatoid arthritis and Crohn’s disease and advance development of the SetPoint proprietary neuromodulation platform.

Medtronic Implants first Activa® PC+S DBS IPG Capable of Sensing and Recording Brain Activity While Delivering Therapy

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 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:

This initiates research on how the brain responds to the therapy and could yield insights that one day significantly change the way people with devastating neurological and psychological disorders, such as Parkinson’s disease, essential tremor, dystonia, and treatment-resistant obsessive-compulsive disorder, are treated.

The Activa® PC+S DBS system delivers proven Medtronic DBS Therapy while at the same time sensing and recording electrical activity in key areas of the brain using sensing technology and an adjustable algorithm, which enable the system to gather brain signals at various moments as selected by a physician. Initially, this new technology will be made available to a select group of physicians worldwide for use in clinical studies. These physicians will use the system to map the brain’s responses to Medtronic DBS Therapy and explore applications for the therapy across a range of neurological and psychological conditions.

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Pacemaker Hacking Hysteria and Conspiracies

Posted on by Posted in Cybersecurity, Tech Talk, Uncategorized

Barnaby Jack Ethical Hacker I’ve been receiving tons of e-mail today from well-meaning friends to tell me about a major story in the news:

“Hacker Found Dead Before Revealing Pacemaker Hacking Secrets”

Actually, the major news outlets just picked up the story.  Ethical hacker Barnaby Jack was found dead on July 25, 2013.

In any case, the media is talking about a conspiracy against Jack, who was supposed to spill the beans on how to hack a pacemaker at the Black Hat Briefings hacking conference in Las Vegas.

In my humble opinion however, there are much easier ways to kill someone than to figure out a target’s IPG model, reverse engineer the AIMD’s communications protocol, and then get close enough to the victim to trigger inappropriate therapy delivery.

Needless to say, the dramatization of such an exploit in the December 2012 “Homeland” episode about a terrorist hacking into the vice-president’s ICD, commanding it to induce VF was totally ridiculous.  Unfortunately, the general public (and the “news” media)  is so ignorant that it believes anything concocted by Hollywood, so it comes to no surprise that Barnaby’s pacemaker hack would cause such sensation.

In reality, if something sinister went on, I would say that criminal minds and powerful players would probably have a lot more interest in Barnaby Jack’s ways of “jackpotting”, or exploiting ATMs in order to make them dispense cash.

The cause of death hasn’t been announced, but no foul play is being suspected by the San Francisco Police Department.

It is obvious that Barnaby Jack was a talented person who was passionate about his work, and it’s unfortunate that the media would exploit his death to sell sensationalistic stories instead of respecting the grief of his loved ones and patiently wait for an official report from the city’s medical examiner’s office.

 

 

Medtronic SureScan Neurostimulators Cleared by FDA for Full-Body MRI

Posted on by Posted in Medtronic, MRI-safe, Pain, Spinal Cord Stimulation

Medtronic Restore Sensor MRI www.implantable-device.comFollowing Medtronic’s announcement in February of this year that it had introduced in Europe the first and only implantable neurostimulation systems indicated for use in the treatment of chronic back and/or leg pain that are designed for full-body Magnetic Resonance Imaging (MRI) scans under specific conditions, the Company announced today that FDA has approved the system for use in the US.  Medtronic SureScan neurostimulation systems include enhancements to existing devices as well as specially designed leads to reduce or eliminate the hazards produced by the MRI environment. The devices also include a proprietary SureScan programming feature, which sets the device into an appropriate mode for the MRI environment.

The press release states:

“With the first U.S. implants of its new RestoreSensor® SureScan® MRI neurostimulation systems, Medtronic, Inc. (NYSE: MDT) is introducing the first and only implantable neurostimulation (also known as spinal cord stimulation, or SCS) systems for use in the treatment of chronic, intractable back and/or limb pain that are approved by the U.S. Food and Drug Administration (FDA) for conditionally safe* full-body Magnetic Resonance Imaging (MRI) under specific conditions.

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Sydney-based Saluda Medical Developing Closed-Loop SCS System for Pain

Posted on by Posted in Pain, Saluda Medical, Spinal Cord Stimulation

Saluda_MedicalStart-up company Saluda Medical has been awarded $5M by Australia’s New South Wales Government to support the development of a closed-loop spinal cord stimulation system for the treatment of pain.

The difference between other SCS systems and Saluda Medical’s is that the latter – the Implanted Neural Sensing & Stimulation product (INS2) – is that it both stimulates and senses nerve responses.

Saluda was spun out of NICTA – Australia’s largest publicly-funded information and communications technology research organization – earlier this year after successfully raising an initial $5M in private investment.  A new $5M grant was provided to Saluda from the inaugural round of the NSW Government’s Medical Devices Fund (MDF), a competitive technology development and commercialization program funded by the NSW Government through the NSW Ministry of Health.

 An excellent technical/business presentation video on the INS2 is available at: http://www.onemedplace.com/database/list/cid/14611/

Boston Scientific’s Q2 2013 AIMD Results: CRM Down 3%, Neuromodulation Up 21%

Posted on by Posted in AIMD Business, Boston Scientific

Boston Scientific LogoToday Boston Scientific announced its Q2 2013 results.  CRM sales were 3% down from $488M for Q2 2012 to $475M this year (2% on constant-currency basis).

Neuromodulation went up by a whopping 21% from last year’s Q2 $91M to $111 in Q2 2013.  The press release indicated that Boston Scientific achieved global year-over-year revenue growth of 21 percent in Neuromodulation on the strength of the Precision Spectra™ Spinal Cord Stimulator (SCS) System launch.

Advanced Glass Encapsulation for AIMDs Offered by Valtronic

Posted on by Posted in Valtronic

Implantable glass encapsulation David Prutchi PhD www.implantable-device.comValtronic is offering advanced glass encapsulation for active implantable devices.  Their first commercial application for this product is for an ingestible pill, but this technology is suitable for many long-term implants that can take advantage of its high density feed-through reliability, intrinsic miniaturization, and radio frequency/light transparency (e.g. implantable RFID tags, sensors, microstimulators, etc.)

Glass encapsulation has been used in other high-tech industries and is a proven technology. Hermetic glass encapsulation provides a totally leak-proof housing for an implant. Glass-sealed packages are used mostly in critical components and assemblies solving several problems in the development and manufacture of active implants due to its strong properties and extended life.

In a recent press release, Jim Ohneck, Valtronic’s Chief Marketing Officer stated:

“This new capability provides Valtronic with a unique opportunity to reduce an implant’s power consumption and increase its functionality while reducing its size.  We have exclusive rights to this technology for the medical industry worldwide and are excited about this great opportunity.”

Valtronic has released an interesting, very informative, and technically-oriented white paper about the technology.  Click here for the pdf file of the white paper.

Implantable glass encapsulation David Prutchi PhD www.implantable-device.com

 

Boston Scientific Launches OPTIMISE Trial of Precision™ Neurostimulator for Treatment of Chronic Migraine

Posted on by Posted in Boston Scientific, Migraine, Occipital Nerve Stimulation

Precision Spectra Spinal Cord Stimulator by Boston Scientific www.implantable-device.com David Prutchi, Ph.D.Boston Scientific announced that it has launched a clinical trial to determine whether occipital nerve stimulation (ONS) using the Precision™ System can safely and effectively treat chronic migraine when used in conjunction with anti-migraine medications.   According to the press release:

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WiTricity Developing Long-Range Transcutaneous Energy Transfer Solutions for AIMDs

Posted on by Posted in Rechargeable Batteries, Thoratec, WiTricity

WiTricity Logo www.implantable-device.comThis month’s Medical Device and Diagnostic Industry  (MD+DI) magazine carried an interesting article by David Schatz – WiTricity’s VP Sales – on their efforts to develop highly resonant wireless power transfer technology for use in AIMDs.  The article is available online at http://www.mddionline.com/article/wireless-power-medical-devices.

The article mentions the work that WiTricity has been doing with Thoratec to wirelessly power a HeartMate II® LVAD, and which was announced back in May 2011.  David told me that for this project, WiTricity has been able to transfer 20 Watts over 20 cm, with SAR and temperature-rise compliance, and without the use of resonant repeaters.

If these levels scale well to small receiver units, I believe that this technology would enable not only the development of deep-implant AIMDs that are currently outside the range of classical resonant-inductive TET, but would also allow the development of more patient-friendly rechargeable AIMDs that don’t require dedicated recharge sessions, but rather receive their charge from a WiTricity transmitter under the patient’s bed while the patient sleeps.  From the MD+DI article:

“A circulatory assist device like an LVAD is just one example of a medical device that can harness the benefits of highly resonant wireless power transfer. There is also promise for other implanted devices, including neurostimulators, implantable defibrillators and pacemakers, implantable drug-delivery pumps, electronic ophthalmic and cochlear implants, and rechargeable hearing aids.

In this broad range of implanted medical devices, high-resonance wireless power transfer can enable higher charge rates than would be possible with traditional magnetic induction. Higher charge rates allow for device implantation deeper within the body and enable more flexible charger configurations outside of the body.

For example, the wireless charger for ophthalmic or cochlear implants could be deployed in a pair of eyeglasses or a pillow. The wireless charger for a neurostimulator implanted in the lower back could be deployed in a chair or bed. Hearing aids could be recharged by simply placing them in a charging box on one’s nightstand, without requiring precise fixturing or galvanic contacts as do today’s rechargeable hearing aids.”