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

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AAMI Technical Information Report Gives Guidance to AIMD Designers Regarding MRI Compatibility

AAMI Guidance Implantable Device Compatibility with MRI

A new technical information report (TIR) provides guidance to design active implantable medical device manufacturers for use in patients who may need magnetic resonance imaging (MRI) scans.

ANSI/AAMI/ISO TIR10974:2012, “Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device” was adopted and published by AAMI is meant to inform manufacturers about device behavior and patient risks so that MR-conditional AIMDs can be designed and labeled appropriately.  The introduction to the TIR explains:

Test methods described in this Technical Specification are primarily designed and intended as bench-top tests using equipment and techniques to simulate the fields (B0 static, gradient, and RF) found in MR 1.5 T scanners. Although, in a few cases, clinical scanner tests are implied, in all others, the AIMD manufacturer assumes the burden for development and validation of clinical scanner-based test methods.  Furthermore, the test signals and parameters specifically described within this Technical Specification for bench-top testing are not being encouraged or recommended for use on clinical scanners and to do so might result in scanner damage.

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

Read more…

 
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Interesting Article in Medical Design Briefs: Designing an ASIC Chip to Control an Implantable Glucose Measurement Device

Senseonics implantable glucose sensor www.implantable-device.com David Prutchi PhDSenseonics implantable glucose sensor www.implantable-device.com David Prutchi PhD

The current issue of Medical Design Briefs carries an interesting article titled “Designing an ASIC Chip to Control an Implantable Glucose Measurement Device” by Uwe Guenther of ZMDI (Dresden, Germany) and Andrew DeHennis of Senseonics (formerly known as “Sensors for Medicine and Science, Inc.” in Germantown, MD).

Zentrum Mikroelektronik Dresden AG (ZMDI), Dresden, Germany, partnered with Senseonics and developed a new microchip for use in Senseionics’ fluorescence-based implantable glucose sensor. According to the article, “ZMDI’s design specifications for this application-specific integrated circuit (ASIC), which is implemented as a system- on-a-chip (SoC) for control and analysis had to meet the following main requirements: LED driver, measurement and analysis of reflected light, data pre-processing, memory, wireless interface for data transfer, no battery due to extremely low power and low voltage requirements, medical certification, and special form factor.”

Click here for the online article.  Click here for a local pdf printout.

 
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Nyxoah Developing Implant for Obstructive Sleep Apnea and Snoring

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

 

 

 

 
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Quallion Being Acquired by EnerSys. Medical Battery Technology Said to be Key Strategic Priority.

Quallion logo

EnerSys, a global leader in stored energy solutions for industrial applications, announced that it has entered into an agreement to acquire Quallion LLC, a manufacturer of lithium ion cells and batteries for high integrity applications for $30 million.   Quallion’s innovative cells – especially rechargeable Zero-Volt ™ lithium-ion batteries – are used in quite a few implantable devices.

According to the press release:

Headquartered in Sylmar, CA, Quallion’s products include lithium ion cells and batteries for diverse applications including medical devices, defense, aviation and space. The closing of the transaction is subject to customary closing conditions.

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Changes in EU Rules for Medical Device Approvals

IPG with CE Mark

There has been some discussion in Europe over the last year to tighten the rules for medical device approvals. This discussion arose due to some scandals with breast implants in recent years.  One of the things being considered was a regulatory approval process similar to the PMA process in the US. The European Parliament has just voted this down, which is great news for our industry.

They did agree on some stricter requirements for Notified Bodies, specifically the following:

  • Notified Bodies must maintain in-house staff members rather than subcontractors to assess medical devices for CE Marking
  • A new group of Notified Bodies should be formed to evaluate higher-risk devices (such as implants)
  • More access to medical device clinical data for patients and healthcare providers
  • New requirements for reprocessing single-use devices
  • Separate legislation addressing IVD safety

These new rules will need to be approved by the EU members states so this is by no means final, but they are expected to have an impact on future AIMD development and approval.

 
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Boston Scientific Posts 1% Increase in Q3 2013 CRM Sales

Boston Scientific Logo

From today’s press release: “Improved performance in the company’s Cardiac Rhythm Management and Interventional Cardiology businesses, with CRM achieving growth of 1 percent on a constant currency basis.”  Sales increased from $462M in Q3 2012 to $464M in Q3 2013, which represents a 1% change in constant-currency basis.

 
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St. Jude Q3 2013 AIMD Results: CRM Down 1%, Neuromodulation 3% Up

logo_StJudeMedical

From today’s press release:

Cardiac Rhythm Management (CRM)

Total CRM sales, which include implantable cardioverter defibrillator (ICD) and pacemaker products, were $682 million for the third quarter of 2013, a 1 percent decrease compared to the third quarter of 2012. After adjusting for the impact of foreign currency, total CRM sales were flat.

Of that total, ICD product sales were $418 million in the third quarter, a 1 percent increase compared to the third quarter of 2012. ICD revenue increased 2 percent after adjusting for the impact of foreign currency.

Second quarter pacemaker sales were $264 million, a 5 percent decrease compared to the third quarter of 2012. On a currency neutral basis, pacemaker revenue declined 3 percent.

Neuromodulation

St. Jude Medical sales of neuromodulation products were $104 million in the third quarter of 2013, up approximately 3 percent from the prior year on a reported and currency neutral basis.

 

 
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Neuros Medical Receives IDE Approval to Conduct Pivotal Study

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.

 

 
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St. Jude Acquires Nanostim, Announces CE Mark of World’s First Leadless Pacemaker

cbhayden@me.com

St. Jude Medical today announced the completion of its acquisition of Nanostim, Inc., a privately-owned developer of miniaturized, leadless pacemakers. The acquisition adds the world’s first and only leadless pacemaker to the St. Jude Medical product portfolio.

According to the press release:

Unlike conventional pacemakers that require a more invasive surgery, the Nanostim™ leadless pacemaker is designed to be implanted directly into the heart via a minimally invasive procedure. The device is delivered using a steerable catheter through the femoral vein, eliminating the need to surgically create a pocket for the pacemaker and insulated wires (called leads) that have historically been recognized as the most vulnerable component of pacing systems. The Nanostim leadless pacemaker recently received CE Mark approval and will be available soon in select European markets. It also recently received U.S. Food and Drug Administration (FDA) conditional approval for its Investigational Device Exemption (IDE) application and pivotal clinical trial protocol to begin evaluating Nanostim leadless technology in the U.S.

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FDA Panel Majority Votes Against Effectiveness of CardioMEMS CHAMPION HF Monitoring Device

CardioMEMS miniature implantable sensor for heart failure and aneurism management

Although the FDA advisory panel found CardioMEMS’ CHAMPION HF Pressure Measurement System to be safe, on October 9, 2013, the majority of panel members decided that the implantable sensor monitor to help guide treatment in patients with congestive heart failure is not effective.

According to Forbes, one panel member said it was difficult to connect the dots between use of the monitor and decreased hospitalization and lack of data on use in women.

This is not the first time that CardioMEMS attempts to receive PMA approval.  In 2011 FDA rejected the Champion implantable monitoring system for heart failure for premarket approval, in part due to questions about the validity of presented data. Last year, CardioMEMS received an FDA Warning Letter.

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

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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Increase in Temperature from AIMDs Dissipating Endogenous Heat

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

 

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

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

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%”

 

 

 

 
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