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

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Magnetically-Coupled Motor/Generator Transfers 100 mW to Implant at 50 cm Range

Magnetically-coupled motor/generator for transcutaneous energy transfer. www.implantable-device.com David Prutchi, Ph.D.

Image Credit: Fraunhofer Institute for Ceramic Technologies and Systems

Scientists at the Fraunhofer Institute for Ceramic Technologies and Systems developed a magnetically-coupled motor/generator system that they claim is able to transcutaneously transfer 100 mW to an implant up to 50 cm away.

In the external power-transfer module, a rotating magnet driven by an EC motor generates a magnetic rotary field. A magnetic pellet in the implanted receiver connects to the alternating exterior magnetic field and as a result, is set in rotation itself. The rotational movement is transformed into electricity, thus the power is produced right in the generator module. “With magnetic coupling, power can be transported through all non-magnetic materials, such as biological tissue, bones, organs, water, plastic or even a variety of metals. Moreover, the magnetic field produced has no harmful side effects on humans. It doesn‘t even heat up tissue,” says Dr. Holger Lausch, highlighting the advantages of the system. Read more…

 
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John Hopkins Researcher Develops New Early-Warning Seizures Detector with Low False-Positive Rate

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.” Read more…

 
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St. Jude Seeks Retraction of Heart Rhythm Journal Manuscript by Dr. Robert Hauser Regarding the Failure of Riata and Riata ST Implantable Cardioverter-Defibrillator Leads

St Jude Medical Riata LeadsSt. Jude announced it is seeking a retraction of the manuscript accepted for publication in the Heart Rhythm Journal by Dr. Robert Hauser, et al., titled, “Deaths Caused by the Failure of Riata and Riata ST Implantable Cardioverter-Defibrillator Leads.” St. Jude claims that the research performed by Hauser undercounted and excluded MAUDE data reports for Medtronic product resulting in substantial factual errors.

According to the press release: Read more…

 
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St. Jude Warns Physicians of Potential Problem with QuickSite and QuickFlex LV CRT Leads

St Jude QuickFlex lead

Image Credit: St. Jude Medical

St. Jude announced it is proactively informing physicians about visual observations of externalized conductors on the silicone end of QuickSite® and QuickFlex® Left-Ventricular Leads, used to connect Cardiac Resynchronization Therapy devices to the heart.

The announcement noted that there have been no reports of patient injury or loss of therapy due to externalized conductors in these leads, but as a conservative measure, St. Jude Medical is communicating with physicians about the incidence rate so they have the most updated lead performance information with which to make important patient care decisions.

According to the announcement, “St. Jude Medical has confirmed 39 cases of externalized conductors, out of 171,000 QuickSite and QuickFlex leads sold worldwide, resulting in a current reported incidence rate of 0.023 percent, or 2.3 in 10,000. Because these leads continue to function normally, the company expects that this rate is under-reported. Based on an analysis of leads returned to the company and recent fluoroscopic images of implanted leads still in clinical use, St. Jude Medical estimates that 3 to 4 percent of QuickSite and QuickFlex leads may exhibit externalized conductors. As a result of this estimated rate, the company felt it was prudent to communicate with physicians about the externalized conductors at this time.”

St. Jude also announced they will no longer sell these lead models.

 
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St. Jude Medical Announces Clinical Benefits of Quadripolar CRT Pacing at ACC

Quadrapolar cardiac resynchronization pacing St Jude Medical Unify Quadra www.implantable-device.com

Image Credit: St. Jude Medical

St. Jude Medical announced that clinical findings on quadripolar pacing will be presented at the 61st Annual Scientific Sessions of the American College of Cardiology (ACC, Chicago, March 24-27 2012).

According to St. Jude’s announcement, quadripolar pacing allows physicians the ability to use multisite left-ventricular (LV) pacing.  Studies that examined the role of multisite pacing in improving hemodynamics and reducing dyssynchrony as compared to traditional bi-ventricular pacing will be presented in the following two posters:

Read more…

 
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FDA AIMD PMA/Supplement Approvals for January

FDA logoFDA released its PMA/Supplement approvals for January.   The edited version below has been edited to include only AIMDs.  It is not the full list, and should be used only for general information purposes.

Read more…

 
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Cool Reed Switch Manufacturing Video

Reed Switch used in implantable medical devices www.implantable-device.com

Magnetic reed switches are used in active implantable medical devices as a simple way of placing the device in a known operational mode when a programmer is not available.  For example, placing a magnet on a pacemaker sets it to VVI mode with a manufacturer-specified set of parameters.  In other devices (e.g. implantable cardioverter/defibrillators), placing a magnet on the IPG inhibits the delivery of high voltage defibrillation.

Although the reed switches that I use don’t come from Meder Electronics, I came across a very cool video that Meder produced regarding their manufacturing process.   Read more…

 
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ImThera Receives CE Mark for the Aura6000 System to Treat Obstructive Sleep Apnea

 

ImThera Aura 6000 implantable device for the treatment of obstructive sleep apnea

Image Credit: Imthera

ImThera Medical announced this week that it received the CE Mark for the Aura6000 System to Treat Obstructive Sleep Apnea. Read more…

 
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Boston Scientific to Acquire Cameron Health for $150M Up-Front + $150M Upon FDA Approval

Cameron Health S-ICD subcutaneous defibrillator

Image Credit: Boston Scientific

Boston Scientific announced the exercise of its option to acquire Cameron Health.  Cameron Health developed the world’s first and only commercially-available subcutaneous implantable cardioverter defibrillator – the S-ICD® System that I blogged about a few weeks ago.

The agreement calls for an upfront payment of $150 million, payable upon transaction closing, an additional potential $150 million payment upon FDA approval of the S-ICD System, plus up to an additional $1.050 billion of potential payments upon achievement of specified revenue-based milestones over a six-year period following FDA approval.  Closing of the transaction is subject to customary conditions, including relevant antitrust clearance, and is expected to occur in the second or third quarter of 2012.

 
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Medtronic Receives CE Mark for CapSure Sense MRI™ SureScan® Pacing Leads

Medtronic SureScan Sense MRI Passive Fixation Leads. www.implantable-device.com

Image Credit: Medtronic

Medtronic today announced the receipt of CE Mark and launch of the CapSure Sense MRI™ SureScan® pacing leads, which are approved for use during MRI procedures.  The newly approved leads are the smallest MR–Conditional leads available in the world with a 5.3 French isodiametric lead body.  The new leads are passive-fixation leads.  Previously approved Medtronic MR–Conditional leads are active fixation leads.

Click here for Medtronic’s product page for the CapSure Sense MRI™ SureScan® Pacing Leads.

 
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News from Stanford: Modelling Tissue as a Dielectric Shows Feasibility of Inductive Power Transfer at 1 GHz

Stanford self-propelled implantable device powered at 1 GHz  www.implantable-device.com

Image Credit: Stanford University

Stanford Engineering assistant professor  Ada Poon demonstrated a tiny, wirelessly powered, self-propelled medical device capable of controlled motion through blood.  The device drives electrical current directly through the fluid, which in the presence of an external magnetic field creates a directional force that pushes the device forward. This type of device is capable of moving at just over half-a-centimeter per second.

That was the news picked up by bloggers from Poon’s presentation at the International Solid-State Circuits Conference (ISSCC).  However, what caught my attention is her work on inductive transcutaneous energy transmission.  From Stanford’s press release: Read more…

 
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Medtronic’s Q3 AIMD Earnings: CRM 3% Down, Neuromodulation 4% Up

Today Medtronic announced financial results for its third quarter of fiscal year 2012, which ended January 27, 2012. According to the report:

“CRDM third quarter revenue of $1.192 billion decreased 2 percent as reported or 3% on a constant currency basis. Third quarter revenue from ICDs was $674 million,  down 9 percent on a constant currency basis, while pacing revenue was $467 million, an increase of 3 percent on a constant currency basis. Weaker ICD sales, primarily due to declining procedure volumes in the U.S. market versus the prior year, were partially offset by continued growth of the AF Solutions and Pacing businesses.”

“Neuromodulation revenue of $419 million increased 4 percent as reported and on a constant currency basis. Growth continues to be driven by strong sales of InterStim® Therapy. The RestoreSensor™ spinal cord stimulator with its proprietary AdaptiveStim™ technology continues to perform well in Europe, and was approved in the U.S. and Japan in the third quarter. The U.S. launch of this product was delayed for most of the quarter due to a supply disruption resulting from the flooding in Thailand, which has subsequently been resolved.”

 
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MicroCHIPS Announces Clinical Results for First Successful Human Trial of Programmable Microchip-Based Drug Delivery Device

MicroCHIPS implantable programmable pump for the treatment of osteoporosis

Image Credit: MicroCHIPS, Inc.

Last month I posted some background on MicroCHIPS, the MIT spinoff to develop implantable sensors and drug-delivery devices.  I concluded that post with the February 2011 announcement that MicroCHIPS started its clinical trial to assess the pharmacokinetics of long-term parathyroid hormone (hPTH 1-34) delivery in women with osteoporosis.

MicroCHIPS announced today the results of the first successful human clinical trial with an implantable, wirelessly controlled and programmable microchip-based drug delivery device. The MicroCHIPS study was published in today’s online edition of the journal Science Translational Medicine. Read more…

 
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iPacemaker Implantable Pacemaker/ICD Database for the iPhone

iPacemaker implantable pacemaker and ICD database for the iPhone

Image Credit: iPacemaker

My friend and colleague Dr. Irit Yaniv alerted me to this iPhone app that was just released.  It is an implantable pacemaker and defibrillator database that, according to its author, displays up to 70 parameters for each model, includes battery and longevity data, and links directly to product manuals. Read more…

 
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The Australian Pacemaker: Telectronics (1965-1995)

Telectronics model 150B VVI pacemaker photographed by David Prutchi, Ph.D.  www.implantable-device.comIn 1965, Australian medical device pioneer Noel Gray established Telectronics – Australia’s first manufacturing facility for producing pacemakers that were designed in-house.  Telectronics was an innovative developer, achieving some major successes in the early cardiac pacing field, for example, Telectronics’ leads allowed narrowing the pacing pulse to its current nominal of 0.5 milliseconds; encapsulating the pacemaker in titanium instead of epoxy; using a microplasma weld to join the two halves of the pacemaker capsule; creating one of the first rate-responsive ‘demand’ pacemakers; and isolating the pacemaker’s battery in a separate compartment to deal with the problem of leaking mercury-zinc batteries. Read more…

 
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