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

Category Archives: AIMD Companies

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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Vibrant’s Vibrating Capsule for Treating Constipation

Posted on by Posted 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

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.

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

Posted on by Posted 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.

 

 

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.

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

Posted on by Posted in AIMD Business, St. Jude Medical

logo_StJudeMedical

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

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

Posted on by Posted 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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