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

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Welcome to implantable-device.com!

Welcome to implantable-device.com, a blog dedicated to professionals interested in the fascinating world of active implantable medical devices!

Let me tell you a bit about myself: I have over twenty years of experience in the design of Medical Electronic Instrumentation, most of it developing active implantable medical devices. In addition to 30 papers and 70 patents on implantable medical devices, I am the lead author of the books “Design and Development of Medical Electronic Instrumentation” and “Exploring Quantum Physics Through Hands-On Projects.”

Please contact me if you would like to contribute to the blog, correct information that you find in these pages, make a news release, or if you have a picture of an implantable device that you would like to share with everyone else.

I hope that you enjoy reading and participating in this blog!

David Prutchi

www.prutchi.com

 
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St. Jude’s Protégé Upgradeable Neurostimulator Receives FDA Approval

St. Jude Protege Neurostimulator www.implantable-device.com David Prutchi PhD

St. Jude Medical today announced the approval of its Protégé™ IPG from the U.S. Food and Drug Administration (FDA). Protégé is the first and only neurostimulation system that allows spinal cord stimulation (SCS) technology upgrades as they are approved to be made via software updates.  According to the press release:

Chronic pain sufferers implanted with this new device can access innovative therapies, stimulation modes, diagnostics or other features once approved through future software upgrades — without the need to surgically replace their medical device.

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Pacesetter’s 1973 Rechargeable Pacemaker

Demo of a rechargeable Pacesetter pacemaker at the Udvar-Hazy Center.  www.implantable-device.com, David Prutchi PhD

Yesterday I visited the Udvar-Hazy Center of the Smithsonian Air & Space Museum in Chantilly, VA.  There I found this demo rechargeable pacemaker being displayed as a spinoff of NASA’s technology with the following explanation:

Demo of a rechargeable Pacesetter pacemaker at the Udvar-Hazy Center.  www.implantable-device.com, David Prutchi PhD

Pacesetter model BD102 VVI rechargeable pacemaker  www.implantable-devices.com David Prutchi PhDI can’t remember exactly where I found the picture of a Pacesetter model BD102 VVI, but the story behind it is documented by Kirk Jeffrey in “Machines in our Hearts”:

“In 1968, Robert Fischell, of the Applied Physics LOaboratory at Johns Hopkins University, and cardiologist Kenneth B. Lewis had begun a collaboration that led in 1973 to a new kind of Ni-Cad battery able to function more effectively at body temperature and hermetically sealable.  Alfred E. Mann, a California entrepreneur with background in the aerospace industry, had provided some financial support to the Hopkins group.  Eventually Mann founded a small company to develop a pacemaker for the rechargeable battery; this was the origin of Pacesetter Systems.  The rechargeable pacemaker reached the market in the summer of 1973, just as CPI introduced its lithium pacer.”

 

 
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Submitting AIMD System Applications to China’s State FDA

Beijing Institute of Medical Device Testing David Prutchi Ph.D. www.implantable-devices.com

I just came back from Beijing where we are in the process of registering our AIMD systems.  The process if very different than submitting an application to a EU Notified Body or to FDA.  This is because China’s State FDA (S-FDA) doesn’t accept testing performed abroad.  S-FDA only accepts testing performed at one of the Chinese nationally-recognized test labs, so it doesn’t matter how or who did your testing outside of China, your devices must be retested by one of the Chinese NRTLs to applicable standards.

Beijing Institute of Medical Device Testing David Prutchi Ph.D. www.implantable-devices.com

We are performing our testing at the Beijing Institute of Medical Devices (BIMT) – a World-Class testing laboratory equipped with the very latest test equipment (including beautiful, new 10m and 30m EMC chambers brought from France, and equipped with top-of-the-line equipment by Rohde&Schwarz, Tektronix, Agilent, etc.).  Most importantly, I found their engineers to be very knowledgeable and kind.  It was a really pleasant experience!

BIMT EMC Chambers David Prutchi PhD

 PS.  My photos of Beijing are at: http://www.flickr.com/photos/prutchi/sets/72157640189751133/

 

 
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Greatbatch Submits Application for CE Mark for its SCS System

Greatbatch Algostim System David Prutchi PhD www.implantable-device.com

On January 20, 2014, Mass Device reported that Greatbatch filed a CE Mark application for its spinal cord stimulation system with German notified body TÜV SÜD America.  The spinal cord stimulation system comes from Greatbatch’s subsidiary, QiG Group. The company also applied for pre-market approval last month.

 

 
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SecondSight Starts US Commercial Implants of Argus II Retinal Prosthesis

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.

 

 
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St. Jude Implants First US Patient with its Nanostim Leadless Cardiac Pacemaker

IMAGE_Nanostim_Product_Shot[1]

St. Jude today announced the first U.S. implant in the company’s LEADLESS II pivotal trial designed to evaluate the Nanostim™ leadless pacemaker for FDA approval. The world’s first retrievable, non-surgical pacemaker was implanted at The Mount Sinai Hospital in New York City by Dr. Vivek Reddy.  The LEADLESS II pivotal trial is a prospective, non-randomized, multi-center, international clinical research trial designed to evaluate the safety and effectiveness of the Nanostim leadless pacemaker in patients indicated for the device. It is being conducted under an Investigational Device Exemption (IDE) from the FDA, and will enroll approximately 670 patients at 50 centers in the U.S., Canada and Europe.

According to the press release:

The Nanostim leadless pacemaker is designed to be placed directly in the heart without the visible surgical pocket, scar and insulated wires (called leads) required for conventional pacemakers. Implanted via the femoral vein with a steerable catheter, the device offers physicians the same pacing therapy through a less-invasive approach as compared to traditional pacemaker procedures that require more extensive surgery. The device is designed to be fully retrievable, so that it can be readily repositioned throughout the implant procedure and later retrieved if necessary.

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Cirtec Offering VersaStim Platform for Development of Neuromodulation Therapies

Cirtec VersaStimCIRTEC Medical Systems has announced the availability of VersaSTIM, a platform for the medical devices manufacturers working to bring new neuromodulation therapies to market.

According to the press release:

“CIRTEC’s new VersaSTIM neuromodulation platform features unprecedented power and flexibility,” said CEO Peter Howard. “It will give startups and large companies alike a huge head start in bringing their proprietary therapies to market.”

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St. Jude Medical Announces Q4 2013 Results: CRM Up 4%, Neuromodulation Up 2%

logo_StJudeMedical

St Jude Medical announced that its Cardiac Rhythm Management sales increased 5 percent on a constant-currency basis over the fourth quarter of 2012.  Neuromodulation sales for the same period increased by 2%.  According to the press release:

Cardiac Rhythm Management

Total CRM sales, which include implantable cardioverter defibrillator (ICD) and pacemaker products, were $705 million for the fourth quarter of 2013, a 3 percent increase compared with the fourth quarter of 2012. After adjusting for the impact of foreign currency, total CRM sales increased 5 percent. Total CRM product sales for the full-year 2013 were $2.783 billion, down approximately 2 percent from 2012. On a constant-currency basis, total CRM sales declined 1 percent from the prior year.

Of that total, ICD product sales were $442 million in the fourth quarter, a 5 percent increase on a reported and constant-currency basis compared with the fourth quarter of 2012. ICD product sales for the full-year 2013 were $1.741 billion, flat when compared with 2012. On a constant-currency basis, total ICD sales increased 1 percent over the prior year.

Fourth quarter pacemaker sales were $263 million, a 1 percent increase compared with the fourth quarter of 2012. On a constant-currency basis, pacemaker product sales increased 4 percent in the fourth quarter. Total pacemaker sales for 2013 were $1.042 billion, down 6 percent compared with pacemaker sales in 2012. On a constant-currency basis, total pacemaker sales declined 4 percent from the prior year.

Neuromodulation

St. Jude Medical sales of neuromodulation products were $115 million in the fourth quarter of 2013, a 2 percent increase on a reported and constant-currency basis over the prior year. Total neuromodulation product sales for 2013 were $426 million, a 1 percent increase over 2012 sales.

 

 

 
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Boston Scientific Announces Q4 2013 Results: CRM Up 3%

Boston Scientific Logo

Boston Scientific announced that it has continued to improve performance in the company’s Cardiac Rhythm Management business, achieving revenue growth of 3 percent versus the prior year period on a constant currency basis from $457M to $468M.

 
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Reveal LINQ: Medtronic’s New Miniaturized Insertable Cardiac Monitoring System

Medtronic Reveal LINQ David Prutchi PhD www.implantable-device.com

Medtronic’s new Reveal LINQ Insertable Cardiac Monitor is a tiny implantable device that weighs less than three grams and is far less invasive than any previous loop recorder.  The figure above shows its diminutive size compared to the Reveal XT device – it is a full 87% smaller!

 The Reveal LINQ is a leadless device that is implanted in the region of the thorax by way of a <1cm incision. Two electrodes on the body of the device continuously monitor the patient’s subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from automatically detected arrhythmias.

 Reveal LINQ stores a total of 57 minutes of ECG, including 27 minutes of automatically-detected episodes and up to 30 minutes of patient-activated recordings with 6.5–14 min. buffers.

The device connects wirelessly with Medtronic’s MyCareLink™ Patient Monitor, making the Reveal LINQ ICM the only ICM to collect and trend data continuously and wirelessly.

 
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Medtronic Performs First Human Implant of its Micra Leadless Pacemaker

Medtronic Micra TPS leadless wireless pacemaker www.implantable-device.com David Prutchi PhD

 

According to the press release:

At one-tenth the size of a conventional pacemaker, and comparable in size to a large vitamin, the Micra TPS is delivered directly into the heart through a catheter inserted in the femoral vein. Once positioned, the pacemaker is securely attached to the heart wall and can be repositioned if needed. The miniature device does not require the use of wires, known as “leads,” to connect to the heart. Attached to the heart via small tines, the pacemaker delivers electrical impulses that pace the heart through an electrode at the end of the device.

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Sorin Announces CE Mark and Implant of its MRI-Compatible Kora 100 Pacemaker with Automatic MRI Mode

Sorin Kora 100 MRI pacemaker David Prutchi PhD www.implantable-device.com

Sorin announced the CE Mark approval and first implant of its KORA 100 pacing system.

According to the press release:

KORA 100 SR and DR pacemakers when implanted with the Sorin BEFLEX pacing lead enable implanted patients to undergo magnetic resonance imaging (MRI) safely.[1] Pacemaker patients are typically older than 65 years. This patient population is prone to other medical conditions such as arthritis, cancer or stroke that may require MRI examinations for optimal diagnosis and management.

The KORA 100 pacing system has been designed with both patients and physicians in mind. Device settings which allow safe operation during an MRI examination are automatically enabled when KORA 100 pacemakers detect the scanner’s magnetic field. Similarly the devices sense when a patient leaves the MRI field, and return to normal operation within five minutes. The Automatic MRI Mode feature, which is patented and available exclusively on Sorin Group pacemakers, limits the amount of time that KORA 100 pacemakers operate in MRI mode.

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

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.

 

 

 
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Boston Scientific Reports Good Results with Precision Spectra™ SCS

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

 
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Medtronic Implants Activa® PC+S DBS IPG in US

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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