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

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Sydney-based Saluda Medical Developing Closed-Loop SCS System for Pain

Start-up company Saluda Medical has been awarded $5M by Australia’s New South Wales Government to support the development of a closed-loop spinal cord stimulation system for the treatment of pain. The difference between other SCS systems and Saluda Medical’s is that the latter – the Implanted Neural Sensing & Stimulation product (INS2) – is that it

 
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Boston Scientific’s Q2 2013 AIMD Results: CRM Down 3%, Neuromodulation Up 21%

Today Boston Scientific announced its Q2 2013 results.  CRM sales were 3% down from $488M for Q2 2012 to $475M this year (2% on constant-currency basis). Neuromodulation went up by a whopping 21% from last year’s Q2 $91M to $111 in Q2 2013.  The press release indicated that Boston Scientific achieved global year-over-year revenue growth

 
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Advanced Glass Encapsulation for AIMDs Offered by Valtronic

Valtronic is offering advanced glass encapsulation for active implantable devices.  Their first commercial application for this product is for an ingestible pill, but this technology is suitable for many long-term implants that can take advantage of its high density feed-through reliability, intrinsic miniaturization, and radio frequency/light transparency (e.g. implantable RFID tags, sensors, microstimulators, etc.) Glass encapsulation

 
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Boston Scientific Launches OPTIMISE Trial of Precision™ Neurostimulator for Treatment of Chronic Migraine

Boston Scientific announced that it has launched a clinical trial to determine whether occipital nerve stimulation (ONS) using the Precision™ System can safely and effectively treat chronic migraine when used in conjunction with anti-migraine medications.   According to the press release:

 
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WiTricity Developing Long-Range Transcutaneous Energy Transfer Solutions for AIMDs

This month’s Medical Device and Diagnostic Industry  (MD+DI) magazine carried an interesting article by David Schatz – WiTricity’s VP Sales – on their efforts to develop highly resonant wireless power transfer technology for use in AIMDs.  The article is available online at http://www.mddionline.com/article/wireless-power-medical-devices. The article mentions the work that WiTricity has been doing with Thoratec to

 
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St. Jude Q2 2013 AIMD Results: CRM Down 4%, Neuromodulation 2% Up

From today’s press release: “Cardiac Rhythm Management (CRM) Total CRM sales, which include implantable cardioverter defibrillator (ICD) and pacemaker products, were $718 million for the second quarter of 2013, a 4 percent decrease compared to the second quarter of 2012. After adjusting for the impact of foreign currency, total CRM sales decreased 2 percent. Of

 
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Algostim – Greatbatch’s Own Spinal Cord Stimulation System

  Greatbatch Medical, which moved its headquarters to the Dallas, TX area last year, announced that it has set a target of at least 5%/yr organic growth.  To accomplish this growth, the Company recently announced consolidating operations of its various divisions in order to create efficiency. In addition however, Greatbatch is diversifying from being strictly a

 
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Greatbatch Reorganizes to Combine Greatbatch Medical and Electrochem Solutions

On June 5, 2013 Greatbatch, Inc. announced  that it would combine Greatbatch Medical and Electrochem Solutions – which have been operating independent operations and sales & marketing groups – into singular sales & marketing and operations groups serving the entire Greatbatch organization.  According to the press release: “We’ve spent the past eight years successfully integrating and consolidating

 
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Enopace Receives Additional $5M Investment for Development of Stimulator for Treatment of Heart Failure

Sorin recently announced a $5 million investment in Israeli startup Enopace Biomedical, which is developing an endovascular neurostimulation system for heart failure.  Back in October 2011 Sorin invested $7 million to finance the initial clinical studies of Enopace’s technology as well as ongoing product development. Very scant details are available besides that it is developing

 
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Neuromodulation Startup NeuroTronik Raises $13.1M for Development of System for Treating Acute Heart Failure Syndrome

NeuroTronik, a recent spin-off from Synecor, a Chapel Hill business accelerator, announced that it has raised $13.1M for the development of a neuromodulation system intended for the treatment of acute heart failure syndrome. Douglas Reed, a partner in the VC group backing NeuroTronik said that the device aims to shorten hospital stays and reduce the need of

 
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EnteroMedics Submits PMA of the Maestro VBLOC System for Treatment of Obesity

EnteroMedics  reported that it has submitted its pre-market approval application for FDA review of its Maestro Rechargeable System’s VBLOC vagal blocking therapy as a treatment for obesity This is an important step for an implantable device company that faced very tough times in 2009 after its US clinical trial failed to meet a critical effectiveness

 
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NeuroPace Raises $18M of Planned $50M

NeuroPace is a privately-held company in Mountain View, CA. Their RNS® implantable stimulator, along with depth leads and cortical strip leads are designed for the treatment of medically refractory partial epilepsy. Unlike Cyberonics’ VNS IPGs, the RNS neurostimulator is designed to detect abnormal electrical activity in the brain and respond by delivering electrical stimulation to

 
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Proposed Microgravity Testing of AIMDs

  With the popularization of space tourism, I would hereby like to propose the addition of a clause to 45502-1 to be titled “Protection of the active implantable medical device from microgravity conditions“.  I propose the following language: The implantable parts of an ACTIVE IMPLANTABLE MEDICAL DEVICE shall be designed and constructed so that no irreversible

 
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TYRX receives FDA Approval for Fully Resorbable AIGISRx R Antibacterial IPG Envelope

AIGISRx® is an Antibacterial Envelope that is made from knitted polypropylene mesh substrate, coated with a polyarylate bioresorbable polymer containing two antimicrobial antibiotics, minocycline and rifampin. AIGISRx is a dual component (resorbable and non-resorbable), sterile prosthesis designed to reduce infection and to stabilize the implantable pacemaker or defibrillator when implanted in the body.

 
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