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

Category Archives: Medtronic

Medtronic Implants Activa® PC+S DBS IPG in US

Posted on by Posted in Alzheimer's, Brain Stimulation, Medtronic, OCD, Parkinson's Disease

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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Medtronic Advisa and Revo MRI SureScan Pacemakers Delays Atrial Fibrillation Disease Progression

Posted on by Posted in Atrial Flutter/Fib, Bradycardia, Cardiac Pacing, Medtronic

Medtronic Advisa www.implantable-device.com David Prutchi PhD

Results for the MINERVA Trial were presented at the AHA Meeting, showing that  Medtronic Advisa and Revo MRI(TM) SureScan(TM) pacemakers reduce the progression of permanent AF by 61%.  According to the press release:

Presented as a late breaking clinical trial at the American Heart Association’s Scientific Sessions 2013, the MINERVA (MINimizE Right Ventricular pacing to prevent Atrial fibrillation and heart failure) study found that Medtronic pacemakers with atrial antitachycardia pacing (Reactive ATP(TM)), managed ventricular pacing (MVP®) and atrial intervention features were able to significantly decrease the incidence of mortality, cardiovascular hospitalizations or permanent AF at two years compared to pacemakers without these features. The effects of these features were most evident by a significant delay in the progression of atrial tachyarrhythmias to permanent AF, with a 61 percent relative risk reduction at two years.

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

Posted on by Posted in AIMD Business, Bradycardia, Brain Stimulation, Medtronic, Pain, Spinal Cord Stimulation, Tachycardia

Medtronic_LogoMedtronic 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 toward stabilization. Pacing revenue was $477 million, an increase of 2 percent on a constant currency basis.”

On related news from the release: “Neuromodulation revenue of $479 million increased 6 percent on both a constant currency and an as reported basis. Growth was driven by strong performance from Activa® deep brain stimulation systems, as well as the launch of the RestoreSensor® SureScan® MRI spinal cord stimulator in the United States.”

Medtronic Implants first Activa® PC+S DBS IPG Capable of Sensing and Recording Brain Activity While Delivering Therapy

Posted on by Posted in Alzheimer's, Brain Stimulation, Medtronic, OCD, Parkinson's Disease

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 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:

This initiates research on how the brain responds to the therapy and could yield insights that one day significantly change the way people with devastating neurological and psychological disorders, such as Parkinson’s disease, essential tremor, dystonia, and treatment-resistant obsessive-compulsive disorder, are treated.

The Activa® PC+S DBS system delivers proven Medtronic DBS Therapy while at the same time sensing and recording electrical activity in key areas of the brain using sensing technology and an adjustable algorithm, which enable the system to gather brain signals at various moments as selected by a physician. Initially, this new technology will be made available to a select group of physicians worldwide for use in clinical studies. These physicians will use the system to map the brain’s responses to Medtronic DBS Therapy and explore applications for the therapy across a range of neurological and psychological conditions.

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Medtronic SureScan Neurostimulators Cleared by FDA for Full-Body MRI

Posted on by Posted in Medtronic, MRI-safe, Pain, Spinal Cord Stimulation

Medtronic Restore Sensor MRI www.implantable-device.comFollowing Medtronic’s announcement in February of this year that it had 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, the Company announced today that FDA has approved the system for use in the US.  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.

The press release states:

“With the first U.S. implants of its new RestoreSensor® SureScan® MRI neurostimulation systems, Medtronic, Inc. (NYSE: MDT) is introducing the first and only implantable neurostimulation (also known as spinal cord stimulation, or SCS) systems for use in the treatment of chronic, intractable back and/or limb pain that are approved by the U.S. Food and Drug Administration (FDA) for conditionally safe* full-body Magnetic Resonance Imaging (MRI) under specific conditions.

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Medtronic Issues Urgent Class-I Recall Notifications for the SynchroMed® Implantable Infusion System

Posted on by Posted in Drug Delivery, Medtronic, Pain

SynchroMed-II[1]

Medtronic’s press release:

MINNEAPOLIS – June 26, 2013 – In June 2013, Medtronic, Inc. (NYSE: MDT) initiated four medical device notifications to customers worldwide about the SynchroMed® Implantable Infusion System. These notifications provide clinicians with information to help identify and manage issues that impact the safe and reliable delivery of therapy using the SynchroMed Implantable Infusion System.

The United States Food and Drug Administration (FDA) has classified three of these notifications as Class I recalls.The fourth notification is an update to a 2011 action related to pump refill which was previously classified by the FDA as a Class I recall.

Patients are encouraged to maintain regular follow-up appointments with their physicians; however, if they experience a change or return of symptoms or hear a device alarm, they should contact their physician immediately. No action is required of physicians beyond the recommendations provided in the notifications.

Medtronic’s intrathecal drug delivery systems are used to treat chronic, intractable pain and severe spasticity of cerebral or spinal origin. These notifications do not involve Medtronic external insulin pumps for diabetes.

Specifically, the Neuromodulation business of Medtronic has initiated the following field corrective actions:

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Medtronic Announces FDA Approval of Next-Generation CRT-D and ICD IPG Families

Posted on by Posted in Bradycardia, Cardiac Pacing, Cardioversion/Defibrillation, Heart Failure (CHF), Medtronic, Tachycardia

Medtronic Evera ICD www.implantable-device.com David Prutchi PhD

Medtronic announced today the FDA approval of its new Viva® portfolio of cardiac resynchronization therapy with defibrillation (CRT-D) devices, and the Evera® portfolio of implantable cardioverter-defibrillators (ICD).  According to the press release:

“The Viva CRT-D significantly improves response rate to the therapy for many indicated heart failure patients, with a demonstrated 21 percent reduction in overall heart failure hospitalizations within the first year after implant as compared to historical CRT trials. According to economic analyses presented at ISPOR Europe, with this device both payers and hospital providers will experience reductions in overall healthcare costs as compared to CRT-D devices with traditional programming.

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Medtronic’s Fully Implantable Percutaneous Nerve Stimulation (PNS) System for Treatment of Lower Back Pain

Posted on by Posted in Medtronic, Pain, PNS, Spinal Cord Stimulation

Medtronic Activa PC used by Functional Neurostimulation for treating Alzheimer'sIn May 2011 Medtronic received the CE Mark for the first 16-electrode, fully implantable system for the percutaneous delivery of peripheral nerve stimulation (PNS) in the management of chronic back pain.

PNS involves an implant of electrical leads just under the skin of the lower back.  These leads are connected to a stimulator which delivers mild electrical impulses to the nerves, interrupting pain signals traveling through the nervous system to the brain.

Medtronic today announced the first patient enrollments in the SubQStim II pivotal clinical trial to pursue FDA approval PNS (also known as subcutaneous nerve stimulation or SQS), for the reduction of chronic, intractable post-surgical back pain.

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Medtronic Introduces First Neuromodulation Systems Compatible with Full-Body MRI

Posted on by Posted 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.

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

Posted on by Posted in Alzheimer's, Brain Stimulation, Dementia, Functional Neuromodulation Ltd., Medtronic

Medtronic Activa PC used by Functional Neurostimulation for treating Alzheimer'sToronto-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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Medtronic Receives CE Mark for CapSure Sense MRI™ SureScan® Pacing Leads

Posted on by Posted in Cardiac Pacing, Medtronic, MRI-safe
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.

DF-4 Connectors for Implantable Cardioverter Defibrillators Enter Use in the US

Posted on by Posted in AIMD Business, Boston Scientific, Cardioversion/Defibrillation, Medtronic, St. Jude Medical, Tachycardia
DF-4 Connector for implantable cardioverter defibrillators

Image Credit: St. Jude Medical

The DF-4 Connector was recently introduced by a joint group of CRM companies, physicians, and regulatory agencies as a way of easing the implant of ICDs by reducing defibrillation connections from three to one and by minimizing the number of set screws.  Prior to the development of the DF-4, traditional high-voltage connector systems required up to three connections. Continue reading→

Medtronic’s Chronicle Implantable Hemodynamic Monitor for Heart Failure Monitoring

Posted on by Posted in ECG Monitoring, Heart Failure (CHF), History, Medtronic, Telemetry
Medtronics Chronicle Implantable Hemodynamics Monitor
Image Credit: Medtronic

The Medtronic Chronicle implantable hemodynamic monitor used a specialized RV lead/sensor.  The device was able to monitor and telemeter:

  • Systolic and diastolic pressure
  • Estimated pulmonary artery diastolic pressure
  • RV dp/dt (positive & negative)
  • Heart rate & activity
  • Core body temperature
  • Continuous remote monitoring
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NDI Medical’s Miniature MicroPulse Neurostimulator

Posted on by Posted in Incontinence, Medtronic, Muscular Stimulation, NDI Medical, Pain, Paralysis, Spinal Cord Stimulation, SPR Therapeutics, Wireless Power Transmission
NDI Medical MicroPulse rechargeable neurostimulator
Image Credit: SPR Therapeutics

NDI Medical was founded in 2002 by Geoffrey B. Thrope to develop and commercialize neurodevice products.  NDI Medical developed the MicroPulse neurostimulator, a thumb-sized, rechargeable pulse generator, that has been used for the treatment of incontinence and pain, as well as an implantable device for the restoration of function of paralyzed limbs.

According to a 2006 news release by the electronics assembly manufacturer for the MicroPulse:

“Using minimally-invasive surgery, the Micropulse is implanted into a patient, usually in the lower abdomen or buttock, where the device is most comfortable and least visible. After implantation, a clinician uses a wireless programmer to set the Micropulse’s stimulus parameter and timing patterns. The programmer, as well as the patient’s controller for the device, has a range of about three feet.

To recharge the device’s lithium-ion battery, the patient applies a recharging patch for several hours to the vicinity of the implant. The battery needs recharging from once a month to every few weeks.” Continue reading→