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

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

Medtronic 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

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

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

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

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

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

WISE (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

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

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

 
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Nyxoah Developing Implant for Obstructive Sleep Apnea and Snoring

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

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

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

 
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Changes in EU Rules for Medical Device Approvals

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

 
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Boston Scientific Posts 1% Increase in Q3 2013 CRM Sales

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

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

 
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Neuros Medical Receives IDE Approval to Conduct Pivotal Study

Neuros 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

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

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

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

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

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

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

 
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Increase in Temperature from AIMDs Dissipating Endogenous Heat

Active 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

 
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