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

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

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

 
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Vibrant’s Vibrating Capsule for Treating Constipation

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

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

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,

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

Biotronik 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

 
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Implantable Blood Analyzer Chip Developed at École Polytechnique Fédérale de Lausanne

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

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

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

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

The 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

 
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Brown University Develops Fully-Implantable Brain-Computer Interface

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.

 
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Retina Implant AG Publishes Study Results on its Alpha IMS Implant

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

 
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Second Sight Receives FDA Clearance for Argus II Retinal Prosthesis

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

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

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%

 
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Medtronic Introduces First Neuromodulation Systems Compatible with Full-Body MRI

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

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

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.

 
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