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

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

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

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

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

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

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.

 
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Implantable Blood Analyzer Chip Developed at École Polytechnique Fédérale de Lausanne

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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Cactus Semiconductor Announces CSI021 Programmable Current Sink/Source IC for Implantable Neurostimulators

Cactus implantable neurostimulation integrated circuit www.implantable-device.com David Prutchi, PhD

Cactus Semiconductor just announced a compact, versatile, fully programmable IC designed for medical device manufacturers involved in peripheral nerve stimulation and other implantable pulse generator applications.

According to the press release: “Cactus Semiconductor, Inc. is pleased to announce the introduction of our first ASSP (Application Specific Standard Product); developed for medical device designers and manufacturers to reduce risk and development time for implantable neurostimulation, neuromodulation and other Implantable Pulse Generator (IPG) applications. The CSI021 will be most beneficial to medical device manufacturers involved in peripheral nerve stimulation by providing a building block suitable for proof-of-concept, trials and even production; depending on the specific application.

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

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

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

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

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%

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.

 

 

 
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Medtronic Introduces First Neuromodulation Systems Compatible with Full-Body MRI

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.

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

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

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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