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

St. Jude Medical Signs $40M Equity Investment and $300M Option with Spinal Modulation

Posted on by Posted in Dorsal Root Ganglion Stimulation, Pain, Spinal Cord Stimulation, Spinal Modulation, St. Jude Medical

Axium Neurostimulator David Prutchi PhD www.implantable-device.comSt. Jude Medical and privately-held Spinal Modulation, Inc., today announced that they have entered into a series of agreements under which St. Jude Medical made a $40 million equity investment in Spinal Modulation, a company that has developed an innovative neuromodulation therapy that provides a new pain management option for patients with chronic, intractable pain.

According to the announcement, “the agreement provides St. Jude Medical with an exclusive option to distribute the Axium™ Neurostimulator System, developed and manufactured by Spinal Modulation, in international markets where it is approved for sale. Additionally, St. Jude Medical will have the exclusive option to acquire the company for up to $300 million plus certain revenue-based milestones following U.S. commercialization.

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Sorin Receives FDA Approval for SMARTVIEW™ Remote Monitoring Solution

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

Sorin Paradym Smartview www.implantable-device.com David Prutchi PhD

Sorin today announced it received FDA approval for and is beginning the U.S. launch of the SMARTVIEW™ remote monitoring solution for patients with CRM devices.  From the press release:

“Using the secure SMARTVIEW remote monitoring solution, physicians and nurses following patients with a Sorin PARADYMTM RF device can access valuable cardiac data and alert messages from the device while the patient is at home. Sorin launched the PARADYMTM RF VR and DR implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy (CRT-D) devices in the United States in May 2012.

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Biotronik Receives FDA Approval for Ilesto 7 ICD/CRT-D Series

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

Biotronik Ilesto ICD CRTD David Prutchi PhD www.implantable-device.comBiotronik announced that FDA granted approval for its Ilesto 7 implantable cardioverter-defibrillator/cardiac resynchronization therapy defibrillator (ICD/CRT-D) series. According to the press release:

“BIOTRONIK lives up to its reputation for excellence in design and manufacturing with the introduction of the Ilesto family, and the new Ilesto DX device. Physicians depend on complete and timely information, and Ilesto DX with BIOTRONIK Home Monitoring® certainly delivers. With this device, physicians can receive atrial information to ensure diagnostic accuracy and identify previously undetected atrial fibrillation. They also receive peace of mind that there is less risk of complications due to the single lead,” said Paul Woodstock, executive vice president of sales and marketing at BIOTRONIK, Inc., USA. “Ilesto’s smaller footprint will be more comfortable as well, which may present a win-win solution for patients and physicians alike.”

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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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NeuroVista Publishes Study Results for their Implantable Seizure-Warning Device

Posted on by Posted in EEG Monitoring, Epilepsy, NeuroVista

 

NeuroVista implantable device for seizure detection www.implantable-device.com David Prutchi PhD

Seattle-based NeuroVista was founded in 2002 by Dr. Daniel DiLorenzo to develop an implantable device for the early detection of epileptic seizures.  The NeuroVista seizure advisory system is based on an implantable device that senses EEG irregularities that precede a seizure. Early warning allows patients to take medicine and find a safe place to lie down. Although some epilepsy sufferers can feel seizures coming, many cannot.

In NeuroVista’s Seizure Advisory System (SAS), intracranial EEG signals are recorded through electrodes implanted between the skull and the brain surface. Data storage and signal telemetry takes place within the pectorally-implanted can that transmits signals wirelessly to an external handheld device that processes the data and transmits visual and audible signals to the patient. The external pager-like receiver displays a blue light when there is a low likelihood of seizures, white indicates medium susceptibility, and red alerts to a high likelihood of impending seizure.

Results of the system on 11 patients were published in the Lancet an a paper entitled “Prediction of seizure likelihood with a long-term, implanted seizure advisory system in patients with drug-resistant epilepsy: a first-in-man study.”  From the paper:

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St. Jude Launches Allure Quadra™ CRT-P IPG with Quadripolar Lead Technology

Posted on by Posted in Bradycardia, Cardiac Pacing, Heart Failure (CHF), St. Jude Medical

St. Jude Launches Allure Quadra™ CRT-P IPG with Quadripolar Lead TechnologySt. Jude Medical today announced CE Mark approval and European launch of its Allure Quadra™ Cardiac Resynchronization Therapy Pacemaker (CRT-P), which brings the quadripolar lead technology to the pacemaker market for the first time.  According to the press release:

“Quadripolar leads allow for increased implant efficiencies, which clinical data indicates can result in fewer surgical revisions. The Allure family of devices also offer enhanced heart failure (HF) diagnostics, including CorVue™ Impedance Monitoring, for improved patient management.

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Micromagnetic Stimulation as an Alternative to Electrical Stimulation for Implantable Devices? I don’t think so…

Posted on by Posted in Magnetic Stimulation, Neural Stimulation, Tech Talk
Principle of micromagnetic stimulation

From: Microscopic magnetic stimulation of neural tissue, Giorgio Bonmassar, Seung Woo Lee, Daniel K. Freeman, Miloslav Polasek, Shelley I. Fried & John T. Gale, Nature Communications 3, Article number: 921

The following captured my attention in the announcement of the 11th World Congress of the International Neuromodulation Society, “Technology Transforming Chronic Illness Management.” From June 8 – 13, 2013:

“Micro-Magnetic Stimulation (Monday, June 10) – John T. Gale, Ph.D., has demonstrated for the first time that deep brain stimulation with micro-magnets can activate brain cells in a living organism. Dr. Gale’s research team has shown that placing a micro-magnet on the auditory pathway of hamsters triggers nerve signal transmission. Stimulation from uniquely designed magnetic fields could avoid unintentional activation of nearby brain areas and the associated side effects. Micro-magnets might one day provide stimulation for heart pacing, cochlear implants, Parkinson’s disease, or neural prosthetics.”

I have worked on TMS before, even home-brewed a TMS device (the design of which is detailed in my book “Design and Development of Medical Electronic Instrumentation: A Practical Perspective of the Design, Construction, and Test of Medical Devices”), but it takes a very large amount of energy to induce sufficient current in the tissue to stimulate excitable tissue, so it peaked my attention that to do so at the implantable level would be under consideration.

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Impulse Dynamics Launches CE-Marked OPTIMIZER IVs System for the Treatment of Heart Failure

Posted on by Posted in Cardiac Stimulation (other), Dr. Shlomo Ben-Haim (Medinvest), Heart Failure (CHF), Impulse Dynamics, My Portfolio

Impulse Dynamics OPTIMIZER IVs IPG for treatment of heart failure

Impulse Dynamics (yes, the company for which I work) launched its new, CE-marked OPTIMIZER™ IVs implantable device for the treatment of heart failure at the 79th Annual Meeting of the German Cardiac Society (Mannheim, Germany, 3–6 April 2013).

The OPTIMIZER™ IVs Implantable Pulse Generator (IPG) is a programmable telemetric device intended to treat moderate to severe heart failure resulting from left ventricular dysfunction by monitoring intrinsic cardiac electrical activity and delivering Cardiac Contractility Modulation (CCM) signals during the ventricular absolute refractory period.  These electrical signals are intended to influence myocardial properties in patients, thereby reducing their symptoms and improving quality of life and exercise tolerance.

The OPTIMIZER™ IVs IPG was designed to deliver CCM signals during the ventricular absolute refractory period in synchrony with locally-sensed electrical activity. The microprocessor controlled implantable device comprises intracardiac electrogram sensing circuits, control logic, communications circuitry, and circuitry to generate the CCM signals.  Electrogram signals are detected from and CCM signals are delivered to the heart using standard chronically-implantable bipolar pacing leads.  The implant procedure is similar to implantation procedures for other cardiac rhythm management devices.

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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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