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

Category Archives: Therapies

AIMDs classified according to general type of therapy

Boston Scientific Acquires and Launches Fixate Tissue Band for Spinal Cord Stimulator Leads and Pain Pump Catheters

Posted on by Posted in Boston Scientific, Drug Delivery, Pain, Spinal Cord Stimulation

Fixate Tissue Band for Spinal Cord Stimulator Leads and Pain Pump Catheters David Prutchi PhD www.implantable-device.com

Boston Scientific announced today that it has acquired the fiXate™ Tissue Band and is launching it in the United States.   The fiXate Tissue Band is intended to be an accessory to the leads/catheter component of Spinal Cord Stimulator/Pain Pump systems functioning to secure the lead to the fascia or inter-spinous/supra-spinous ligament.  According to the press release:

“The fiXate Tissue Band is a novel suturing device that is designed to enable quick and simple placement of a suture to help secure a spinal cord stimulator (SCS) lead or pain pump catheter. Boston Scientific introduced the device earlier this month at the annual meeting of the American Academy of Pain Medicine in Fort Lauderdale. The product was purchased from Anulex Technologies, Inc.

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Boston Scientific’s Precision Spectra™ 32-Contact SCS Launched in the US

Posted on by Posted in Boston Scientific, Pain, Spinal Cord Stimulation

Precision Spectra SCS David Prutchi PhD www.implantable-device.comBoston Scientific received FDA approval and is beginning a limited launch of the Precision Spectra Spinal Cord Stimulator (SCS) System.  According to the press release:

“The Precision Spectra System is the world’s first and only SCS system with Illumina 3D™ software and 32 contacts, and is designed to provide improved pain relief to a wide range of patients who suffer from chronic pain. Boston Scientific, the United States market leader in rechargeable SCS devices exiting 2012, is introducing the system at the annual meeting of the American Academy of Pain Medicine in Fort Lauderdale, Florida. Images of the Precision Spectra System can be downloaded here.

More than 100 million Americans suffer from chronic pain. Living in constant pain for an extended period of time can have a devastating impact on quality of life for many patients. Without relief, or the hope for relief, many patients lose the ability to sleep, work and function normally.

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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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St. Jude’s DBS Systems First to Receive CE Mark for Both Primary and Secondary Dystonia

Posted on by Posted in Brain Stimulation, Dystonia, Parkinson's Disease, St. Jude Medical

St Jude Medical implantable devices for dystonia David Prutchi PhD www.implantable-device.com

St. Jude Medical announced CE Mark approval of its Brio™, Libra™ and LibraXP™ deep brain stimulation (DBS) systems for managing the symptoms of intractable primary and secondary dystonia, a neurological movement disorder that causes a person’s muscles to contract and involuntarily spasm, reducing the ability to control movement. This approval represents the first by a regulatory agency for the use of deep brain stimulation to manage both primary and secondary dystonia.

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Sorin Receives Conditional FDA IDE Approval to Study its Paradym CRT-D IPG and SonRtip Hemodynamic Sensor Lead

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

Sorin Paradym CRT-D David Prutchi PhD www.implantable-device.comSorin announced it received U.S. Food and Drug Administration (FDA) conditional approval for its Investigational Device Exemption (IDE) application and clinical trial protocol for RESPOND CRT. The trial will study the safety and effectiveness of the innovative SonR cardiac resynchronization therapy (CRT) optimization system in patients with advanced heart failure. RESPOND CRT is a multi-center, randomized, two-arm, double-blinded, prospective trial that will enroll more than 1,000 patients in the United States and other geographies.

The SonR optimization system is comprised of the SonR hemodynamic sensor embedded in the SonRtip atrial pacing lead and the PARADYM RF SonR CRT-D device, which includes a unique algorithm to automatically optimize the patient’s atrioventricular (AV) delay and interventricular (VV) delay timing. While there are several CRT systems on the market, studies have shown that approximately one-third of patients with advanced heart failure do not effectively respond to CRT. The SonR system is the first and only CRT hemodynamic sensor based system designed to automatically adjust on a weekly basis. The timing of electrical impulses delivered to the heart is based on the patient’s heart activity and need – with the goal of improving the patient’s response to CRT. Typically this device re-programming is done manually in the clinic using echocardiography.

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

Posted on by Posted 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.comBiotronik 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.

Implantable Blood Analyzer Chip Developed at École Polytechnique Fédérale de Lausanne

Posted on by Posted in Cancer, Diabetes, Telemetry
Implantable blood analyzer chip

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

Posted on by Posted in Circulatory Support, CircuLite, Heart Failure (CHF)

CircuLite Vascular Support Pump www.implantable-device.com David Prutchi PhDThe 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

Posted on by Posted 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

Posted on by Posted 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

Posted on by Posted in Alfred E. Mann, Blindness, Retinal Stimulation, retinitis pigmentosa, Second Sight

Second Sight Argus II Retinal Prosthesis www.implantable-device.com David Prutchi PhD

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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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.

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

Posted on by Posted 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

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

Posted on by Posted 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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