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

Welcome to implantable-device.com!

Published on December 9, 2011 by David Prutchi in Administrative

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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Sorin Receives FDA Approval for SMARTVIEW™ Remote Monitoring Solution

Published on May 14, 2013 by David Prutchi 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.

Read more…

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

Published on May 8, 2013 by David Prutchi in Biotronik, Bradycardia, Cardiac Pacing, Cardioversion/Defibrillation, Heart Failure (CHF), Tachycardia

Biotronik 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

Published on May 6, 2013 by David Prutchi 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

Published on May 2, 2013 by David Prutchi 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

Published on April 30, 2013 by David Prutchi in Bradycardia, Cardiac Pacing, Heart Failure (CHF), St. Jude Medical

St. Jude Launches Allure Quadra™ CRT-P IPG with Quadripolar Lead Technology St. 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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Boston Scientific’s Q1 3013 AIMD Results: CRM Down 4%, Neuromodulation Up 6%

Published on April 25, 2013 by David Prutchi in AIMD Business, Boston Scientific

Boston Scientific Logo

Boston Scientific Corporation announced today that it generated sales of $1.761 billion and adjusted earnings per share of $0.16 for the first quarter ended March 31, 2013. These were the results for their AIMD businesses :

Cardiac Rhythm Management declined 5% (4% using constant-currency basis) to $478M in Q1 2013 compared to $501M in Q1 2012.
Neuromodulation was up 6% to $89M in Q1 2013 vs. $84M in Q1 2012.

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

Published on April 20, 2013 by David Prutchi in Magnetic Stimulation, Neural Stimulation, Tech Talk

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

Published on April 18, 2013 by David Prutchi in Cardiac Stimulation (other), Dr. Shlomo Ben-Haim (Medinvest), Heart Failure (CHF), Impulse Dynamics, My Portfolio

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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St. Jude’s Q1 2013 AIMD Results: CRM Down 7%, Neuromodulation Down 4%

Published on April 18, 2013 by David Prutchi in AIMD Business, St. Jude Medical

logo_StJudeMedical

St. Jude Medical announced sales results for Q1 2013. AIMD results from their press release:

“Cardiac Rhythm Management (CRM)

Total CRM sales, which include implantable cardioverter defibrillator (ICD) and pacemaker products, were $678 million for the first quarter of 2013, an 8 percent decrease compared to the first quarter of 2012. After adjusting for the impact of foreign currency, total CRM sales decreased 7 percent.

Of that total, ICD product sales were $427 million in the first quarter, a 5 percent decrease compared to the first quarter of 2012. ICD revenue decreased 4 percent after adjusting for the impact of foreign currency.

First quarter pacemaker sales were $251 million, a 12 percent decrease compared to the first quarter of 2012.”

…

“Neuromodulation

St. Jude Medical sales of neuromodulation products were $99 million in the first quarter of 2013, down 4 percent from the prior year.”

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

Published on April 15, 2013 by David Prutchi 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

Published on April 12, 2013 by David Prutchi in Boston Scientific, Pain, Spinal Cord Stimulation

Boston 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

Published on April 11, 2013 by David Prutchi in Medtronic, Pain, PNS, Spinal Cord Stimulation

In 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

Published on April 10, 2013 by David Prutchi 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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Vibrant’s Vibrating Capsule for Treating Constipation

Published on April 1, 2013 by David Prutchi in Constipation, Vibrant Ltd.

Vibrant Capsule for tretment of constipation www.implantable-device.com

I know that it’s April 1st, but this post is not an April Fool’s joke. Israeli company Vibrant Ltd. has developed a vibrating capsule that the Company claims to provide chemical-free and safe treatment for patients suffering from constipation. According to Vibrant:

“The capsules, mechanically operated, aid in treating constipated patients without side effects.

Constipation relief is achieved by the capsule’s vibrations on the large intestinal wall, consequently inducing natural peristaltic activity, generating spontaneous additional bowel movement.

Vibrant capsule is easy to swallow. The capsule is controlled through algorithms, predefined by Vibrant’s R&D and gastroenterologist.

The capsule is activated by a base unit that transfers the data of the predefined algorithm into the capsule, before swallowing it.

The capsule operates inside the large intestine and is washed out of the body with the bowel movement.”

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

Published on March 28, 2013 by David Prutchi in Bradycardia, Cardiac Pacing, Cardioversion/Defibrillation, Heart Failure (CHF), Sorin, Tachycardia

Sorin 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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Page 1 of 1212 3 4 5 Next ›Last »

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

Welcome to implantable-device.com!

Sorin Receives FDA Approval for SMARTVIEW™ Remote Monitoring Solution

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

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

NeuroVista Publishes Study Results for their Implantable Seizure-Warning Device

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

Boston Scientific’s Q1 3013 AIMD Results: CRM Down 4%, Neuromodulation Up 6%

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

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

St. Jude’s Q1 2013 AIMD Results: CRM Down 7%, Neuromodulation Down 4%

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

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

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

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

Vibrant’s Vibrating Capsule for Treating Constipation

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

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