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

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

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:

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

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

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

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

 
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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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