The World of Implantable Devices

Sulzer-Intermedics Nexus IPG Prototype

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Optimizer III

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OPT III and ICD implant xray

Biotronik’s Iforia DF4 ICD/CRT-D CE-Approved as Compatible with MRI

Published on March 28, 2013 by David Prutchi in Biotronik, Cardiac Pacing, Cardioversion/Defibrillation, Heart Failure (CHF), MRI-safe, Tachycardia

Iforia MRI-compatible ICD/CRT CRT-D David Prutchi PhD www.implantable-device.com Biotronik announced that it had received CE-approval for the world’s first DF4 ICD/CRT-D series approved for MRI. In addition, this series contains one of the world’s smallest ICDs– the Iforia single chamber ICD.

Aside from featuring ProMRI®technology, which allows patients to undergo potentially life saving MRI scans, Iforia also includes the industry standard DF4 connector system, which is designed to simplify and shorten the implantation procedure. The DF4 connector combines the traditional three connectors into one, allowing for a more convenient implantation procedure without compromising safety.

Click here for the press release.

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Implantable Blood Analyzer Chip Developed at École Polytechnique Fédérale de Lausanne

Published on March 20, 2013 by David Prutchi in Cancer, Diabetes, Telemetry

Image Credit: EPFL. This implant measures about 14mm and comprises five sensors, a coil for wireless power as well a miniaturized electronics for radio communication

From Wired:

Written by Liat Clark

Edited by Nate Lanxon

“A multidisciplinary Swiss team has developed a tiny, implantable device that instantly analyses the blood before wirelessly sending the data to a doctor.

The device can be used for monitoring general health, but the team also sees immediate applications in monitoring the efficacy of treatments such as chemotherapy in order to tailor drug delivery to a patient’s unique needs.

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Cactus Semiconductor Announces CSI021 Programmable Current Sink/Source IC for Implantable Neurostimulators

Published on March 7, 2013 by David Prutchi in Cactus Semiconductor, Ultra-Low-Power ICs

Cactus Semiconductor just announced a compact, versatile, fully programmable IC designed for medical device manufacturers involved in peripheral nerve stimulation and other implantable pulse generator applications.

According to the press release: “Cactus Semiconductor, Inc. is pleased to announce the introduction of our first ASSP (Application Specific Standard Product); developed for medical device designers and manufacturers to reduce risk and development time for implantable neurostimulation, neuromodulation and other Implantable Pulse Generator (IPG) applications. The CSI021 will be most beneficial to medical device manufacturers involved in peripheral nerve stimulation by providing a building block suitable for proof-of-concept, trials and even production; depending on the specific application.

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CircuLite Receives Approval to Start IDE Trial of its SYNERGY Circulatory Support System

Published on March 7, 2013 by David Prutchi in Circulatory Support, CircuLite, Heart Failure (CHF)

The SYNERGY Circulatory Support System is a micro-blood pump that provides up to 4.25 liters of blood per minute and reduces the heart’s workload, while improving blood flow to vital organs. The system is surgically implanted using a mini-thoracotomy and the micro-pump is placed in a pacemaker-like pocket. The system’s less invasive procedure is intended to reduce the surgical risks associated with cardiopulmonary bypass support. In addition, SYNERGY is intended to reduce rehospitalizations associated with heart failure symptoms. SYNERGY is designed and manufactured in Aachen, Germany.

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Brown University Develops Fully-Implantable Brain-Computer Interface

Published on March 1, 2013 by David Prutchi in Brain-Computer Interface, EEG Monitoring, Paralysis

Brown University's fully-implantable brain-computer interface www.implantable-device.com David Prutchi, PhD

From Brown University’s press release:

“In a significant advance for brain-machine interfaces, engineers at Brown University have developed a novel wireless, broadband, rechargeable, fully implantable brain sensor that has performed well in animal models for more than a year. They describe the result in the Journal of Neural Engineering and at a conference this week.

PROVIDENCE, R.I. [Brown University] — A team of neuroengineers based at Brown University has developed a fully implantable and rechargeable wireless brain sensor capable of relaying real-time broadband signals from up to 100 neurons in freely moving subjects. Several copies of the novel low-power device, described in the Journal of Neural Engineering, have been performing well in animal models for more than year, a first in the brain-computer interface field. Brain-computer interfaces could help people with severe paralysis control devices with their thoughts.

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Retina Implant AG Publishes Study Results on its Alpha IMS Implant

Published on February 23, 2013 by David Prutchi in Blindness, Retina Implant AG, Retinal Stimulation, retinitis pigmentosa

Retina Implant AG www.implantable-device.com David Prutchi PhD

Retina Implant AG published study results on its Alpha IMS Implant for functional vision restoration. According to the press release, “Retina Implant AG, the leading developer of subretinal implants for patients blinded by retinitis pigmentosa (RP), announced results from part of its multicentre study were published today in the peer-reviewed journal Proceedings of the Royal Society B. The research found that, during the course of a three to nine month observation period, functional vision was restored in the majority of nine German patients implanted with a subretinal microchip as part of the first module of the Company’s second human clinical trial. In addition, visual acuity for two of the nine patients surpassed the visual resolution of patients from the Company’s first human clinical trial.

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Second Sight Receives FDA Clearance for Argus II Retinal Prosthesis

Published on February 18, 2013 by David Prutchi in Alfred E. Mann, Blindness, Retinal Stimulation, retinitis pigmentosa, Second Sight

On February 4, 2013, after more than 20 years of research and development, Second Sight Medical Products, Inc., announced that its Argus® II Retinal Prosthesis System (“Argus II”) has received U.S. market approval from the Food and Drug Administration (FDA) to treat individuals with late stage retinitis pigmentosa (RP). This announcement follows receipt of the European approval in 2011, and a unanimous recommendation by the FDA’s Ophthalmic Devices Advisory Panel in September 2012 that this revolutionary product be made available to treat this patient population in the U.S.

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Boston Scientific Releases 2012 AIMD Sales Report: CRM Down 7%, Neuromodulation Up 9%

Published on February 1, 2013 by David Prutchi in AIMD Business, Boston Scientific

Boston Scientific Logo

Boston Scientific reported Q4 2012 CRM sales of $457M versus $482M for Q4 2011, or a decline of 5% (4% on constant-currency basis). For the same period, neuromodulation sales grew by 14% from $91M to $104M.

Worldwide CRM sales for the full 2012 year were $1,908M compared to $2,087M for 2011, or a decline of 9% (7% on constant-currency basis). Neuromodulation sales grew by 9% for 2012 to $367M from $336 in 2011.

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Medtronic Introduces First Neuromodulation Systems Compatible with Full-Body MRI

Published on February 1, 2013 by David Prutchi in Brain Stimulation, Medtronic, MRI-safe, Pain, Spinal Cord Stimulation

Medtronic Restore Sensor MRI www.implantable-device.com

Medtronic has 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. 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.

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St. Jude Releases 2012 Year-End Results: CRM Down 6%, Neuromodulation Up 1%

Published on January 23, 2013 by David Prutchi in AIMD Business, St. Jude Medical

St. Jude Medical today reported sales and net earnings for the fourth quarter and year ended December 29, 2012. According to the announcement:

“Total CRM sales, which include implantable cardioverter defibrillator (ICD) and pacemaker products, were $682 million for the fourth quarter of 2012, a 6 percent decrease compared to the fourth quarter of 2011. After adjusting for the impact of foreign currency, total CRM sales decreased 5 percent. Total CRM product sales for the full-year 2012 were $2.854 billion, down approximately 6 percent from 2011. On a currency neutral basis, total CRM sales declined 3.5 percent from the prior year.

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SetPoint Medical’s Vagus Nerve Stimulation for Treatment of Systemic Inflammation

Published on December 13, 2012 by David Prutchi in 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.

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Functional Neuromodulation Ltd. Starts Study using DBS of the Fornix (DBS-f) for Mild Alzheimer’s

Published on December 13, 2012 by David Prutchi in Alzheimer's, Brain Stimulation, Dementia, Functional Neuromodulation Ltd., Medtronic

Medtronic Activa PC used by Functional Neurostimulation for treating Alzheimer's Toronto-based Functional Neuromodulation announced that it implanted the first U.S. Alzheimer’s patient in the “ADvance Study” with a deep brain stimulation (DBS) system meant to improve cognitive performance. ADvance will evaluate the safety and potential clinical benefit of DBS of the fornix (DBS-f), a major inflow and output pathway in the brain’s memory circuit, for patients with mild Alzheimer’s. The ADvance Study is being conducted using Medtronic Activa DBS IPGs.

While DBS has been an effective treatment for movement disorders for more than 15 years, it was only recently that this approach was first applied to Alzheimer’s. Dr. Andres Lozano, a neurosurgeon at University of Toronto and Scientific Founder of Functional Neuromodulation, originated the concept of treating memory disorders using deep brain stimulation (DBS) while treating a patient suffering from morbid obesity. In this patient, DBS stimulation of the hypothalamus and fornix was associated with an unexpected observed improvement in the patient’s memory.

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Boston Scientific’s Precision Spectra™ SCS with 32 Contacts and 32 Dedicated Power Sources Receives CE Mark

Published on December 13, 2012 by David Prutchi in Boston Scientific, Pain, Spinal Cord Stimulation

Precision Spectra Spinal Cord Stimulator by Boston Scientific www.implantable-device.com David Prutchi, Ph.D.

Boston Scientific Received European Regulatory Approval For New Precision Spectra™ Spinal Cord Stimulator System. It is the first and so-far only SCS system with 32 contacts and 32 dedicated power sources designed to provide pain relief to a broad spectrum of chronic pain patients.

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Boston Scientific Defibrillators Receive CE Mark for 10-Year Longevity Projections

Published on December 13, 2012 by David Prutchi in AIMD Business, Boston Scientific, Bradycardia, Cardiac Pacing, Cardioversion/Defibrillation, Heart Failure (CHF), Power Sources, Tachycardia

Boston Scientific Incepta ICD with DF-4 connector

Image Credit: Boston Scientific

Boston Scientific has received CE Mark approval for increased longevity projections for the INCEPTA™, ENERGEN™, PUNCTUA™, COGNIS® and TELIGEN® implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). The longevity projections are based on data submitted to the European authorities and vary for each device dependent on the model type and settings.

Projected device longevity exceeds 10 years for some models, approaches eight years for its CRT-D devices, and according to the press release is up to double that of comparable competitive device models. The company supports these devices with warranties of up to 10 years:

Warranties: INCEPTA and ENERGEN VR ICD: 10 years; INCEPTA and ENERGEN DR ICD: eight years; PUNCTUA and TELIGEN ICD: seven years; INCEPTA and ENERGEN CRT-D: six years; and PUNCTUA & COGNIS CRT-D: five years.

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RF Programming Hack Demonstrates Potentially Fatal ICD Exploit

Published on October 18, 2012 by David Prutchi in Tachycardia, Tech Talk

I received today a link to a very interesting article which plays on the fears of the public, and which I am sure will result in tough new regulations to our industry.

The article discusses how IOActive researcher Barnaby Jack reverse-engineered a ”pacemaker transmitter” (probably a programmer or a MICS module) to command ICDs within a 30 feet range to fire, or to rewrite their firmware.

This is the reason why MICS (“RF telemetry”) is under renewed scrutiny by regulators. Thoughts for mitigating this issue include requiring authentication and exchange of encryption keys via close-range (inductive) telemetry and other means before allowing any programming via MICS.

Click here for the original article. The text reads:

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

Biotronik’s Iforia DF4 ICD/CRT-D CE-Approved as Compatible with MRI

Implantable Blood Analyzer Chip Developed at École Polytechnique Fédérale de Lausanne

Cactus Semiconductor Announces CSI021 Programmable Current Sink/Source IC for Implantable Neurostimulators

CircuLite Receives Approval to Start IDE Trial of its SYNERGY Circulatory Support System

Brown University Develops Fully-Implantable Brain-Computer Interface

Retina Implant AG Publishes Study Results on its Alpha IMS Implant

Second Sight Receives FDA Clearance for Argus II Retinal Prosthesis

Boston Scientific Releases 2012 AIMD Sales Report: CRM Down 7%, Neuromodulation Up 9%

Medtronic Introduces First Neuromodulation Systems Compatible with Full-Body MRI

St. Jude Releases 2012 Year-End Results: CRM Down 6%, Neuromodulation Up 1%

SetPoint Medical’s Vagus Nerve Stimulation for Treatment of Systemic Inflammation

Functional Neuromodulation Ltd. Starts Study using DBS of the Fornix (DBS-f) for Mild Alzheimer’s

Boston Scientific’s Precision Spectra™ SCS with 32 Contacts and 32 Dedicated Power Sources Receives CE Mark

Boston Scientific Defibrillators Receive CE Mark for 10-Year Longevity Projections

RF Programming Hack Demonstrates Potentially Fatal ICD Exploit

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