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

Facebook Twitter Gplus Flickr LinkedIn YouTube RSS
magnify
Home Articles posted by David Prutchi (Page 3)
formats

WISE s.r.l. Raises €1M to Develop Flexible Electrodes for Spinal Cord Stimulation

WISE (Wiringless Implantable Stretchable Electronics), a Milan- and Berlin-based medical device companyraised a seed-round of € 1 M to advance the development of its first product aimed at the spinal cord stimulation market. WISE’s technology relies on Supersonic Cluster Beam Implantation (SCBI) for the metallization of polymers and elastomers. SCBI allows to fabricate complex microelectronic

 
 Share on Facebook Share on Twitter Share on Reddit Share on LinkedIn
Comments Off on WISE s.r.l. Raises €1M to Develop Flexible Electrodes for Spinal Cord Stimulation  comments 
formats

Interesting Article in Medical Design Briefs: Designing an ASIC Chip to Control an Implantable Glucose Measurement Device

The current issue of Medical Design Briefs carries an interesting article titled “Designing an ASIC Chip to Control an Implantable Glucose Measurement Device” by Uwe Guenther of ZMDI (Dresden, Germany) and Andrew DeHennis of Senseonics (formerly known as “Sensors for Medicine and Science, Inc.” in Germantown, MD). Zentrum Mikroelektronik Dresden AG (ZMDI), Dresden, Germany, partnered

 
 Share on Facebook Share on Twitter Share on Reddit Share on LinkedIn
Comments Off on Interesting Article in Medical Design Briefs: Designing an ASIC Chip to Control an Implantable Glucose Measurement Device  comments 
formats

Nyxoah Developing Implant for Obstructive Sleep Apnea and Snoring

Nyxoah was founded in 2009 by Robert Taub and Dr. Adi Mashiach to develop neurostimulation treatments focused for Obstructive Sleep Apnea. Nyxoah is currently engaged in clinical tests of a tiny, battery-less implantable neurostimulator that can electrically control the nerves of the tongue and so prevent airway blockage. According to Nyxoah, the implantable device is

 
Tags:
 Share on Facebook Share on Twitter Share on Reddit Share on LinkedIn
Comments Off on Nyxoah Developing Implant for Obstructive Sleep Apnea and Snoring  comments 
formats

Quallion Being Acquired by EnerSys. Medical Battery Technology Said to be Key Strategic Priority.

EnerSys, a global leader in stored energy solutions for industrial applications, announced that it has entered into an agreement to acquire Quallion LLC, a manufacturer of lithium ion cells and batteries for high integrity applications for $30 million.   Quallion’s innovative cells – especially rechargeable Zero-Volt ™ lithium-ion batteries – are used in quite a few implantable

 
 Share on Facebook Share on Twitter Share on Reddit Share on LinkedIn
Comments Off on Quallion Being Acquired by EnerSys. Medical Battery Technology Said to be Key Strategic Priority.  comments 
formats

Changes in EU Rules for Medical Device Approvals

There has been some discussion in Europe over the last year to tighten the rules for medical device approvals. This discussion arose due to some scandals with breast implants in recent years.  One of the things being considered was a regulatory approval process similar to the PMA process in the US. The European Parliament has

 
 Share on Facebook Share on Twitter Share on Reddit Share on LinkedIn
Comments Off on Changes in EU Rules for Medical Device Approvals  comments 
formats

Boston Scientific Posts 1% Increase in Q3 2013 CRM Sales

From today’s press release: “Improved performance in the company’s Cardiac Rhythm Management and Interventional Cardiology businesses, with CRM achieving growth of 1 percent on a constant currency basis.”  Sales increased from $462M in Q3 2012 to $464M in Q3 2013, which represents a 1% change in constant-currency basis.

 
 Share on Facebook Share on Twitter Share on Reddit Share on LinkedIn
Comments Off on Boston Scientific Posts 1% Increase in Q3 2013 CRM Sales  comments 
formats

St. Jude Q3 2013 AIMD Results: CRM Down 1%, Neuromodulation 3% Up

From today’s press release: Cardiac Rhythm Management (CRM) Total CRM sales, which include implantable cardioverter defibrillator (ICD) and pacemaker products, were $682 million for the third quarter of 2013, a 1 percent decrease compared to the third quarter of 2012. After adjusting for the impact of foreign currency, total CRM sales were flat. Of that

 
 Share on Facebook Share on Twitter Share on Reddit Share on LinkedIn
Comments Off on St. Jude Q3 2013 AIMD Results: CRM Down 1%, Neuromodulation 3% Up  comments 
formats

Neuros Medical Receives IDE Approval to Conduct Pivotal Study

Neuros Medical received an Investigational Device Exemption to conduct a pivotal clinical trial to evaluate the Altius™ System High Frequency Nerve Block technology for the management of intractable limb pain of amputees.   The prospective, randomized, controlled pivotal clinical trial will consist of 130 patients at 15 institutions in the U.S. to evaluate the safety and

 
 Share on Facebook Share on Twitter Share on Reddit Share on LinkedIn
Comments Off on Neuros Medical Receives IDE Approval to Conduct Pivotal Study  comments 
formats

St. Jude Acquires Nanostim, Announces CE Mark of World’s First Leadless Pacemaker

St. Jude Medical today announced the completion of its acquisition of Nanostim, Inc., a privately-owned developer of miniaturized, leadless pacemakers. The acquisition adds the world’s first and only leadless pacemaker to the St. Jude Medical product portfolio. According to the press release: Unlike conventional pacemakers that require a more invasive surgery, the Nanostim™ leadless pacemaker

 
 Share on Facebook Share on Twitter Share on Reddit Share on LinkedIn
Comments Off on St. Jude Acquires Nanostim, Announces CE Mark of World’s First Leadless Pacemaker  comments 
formats

FDA Panel Majority Votes Against Effectiveness of CardioMEMS CHAMPION HF Monitoring Device

Although the FDA advisory panel found CardioMEMS’ CHAMPION HF Pressure Measurement System to be safe, on October 9, 2013, the majority of panel members decided that the implantable sensor monitor to help guide treatment in patients with congestive heart failure is not effective. According to Forbes, one panel member said it was difficult to connect the dots between

 
 Share on Facebook Share on Twitter Share on Reddit Share on LinkedIn
Comments Off on FDA Panel Majority Votes Against Effectiveness of CardioMEMS CHAMPION HF Monitoring Device  comments 
formats

MicroTransponder Raises Funds for Clinical Trials of Serenity VNS IPG for Treating Tinnitus

MicroTransponder, Inc. of Dallas, TX has raised $3.4 million to carry out clinical trials of its Vivistim System to help restore functionality in the upper limbs of stroke patients, and its Serenity System designed to “rewire” the auditory cortex of tinnitus patients. The company intends to secure a CE mark for both systems next year, and then

 
 Share on Facebook Share on Twitter Share on Reddit Share on LinkedIn
Comments Off on MicroTransponder Raises Funds for Clinical Trials of Serenity VNS IPG for Treating Tinnitus  comments 
formats

Increase in Temperature from AIMDs Dissipating Endogenous Heat

Active Implantable Medical Devices generate heat as a result of resistive losses in their circuitry, exothermic reaction in their batteries, eddy-current heating due to inductive recharge, friction between mechanical components, etc.  The European Standard which regulates AIMDs limits the heating of the outer surface of an AIMD to 2ºC above normal body temperature.  Despite the

 
 Share on Facebook Share on Twitter Share on Reddit Share on LinkedIn
Comments Off on Increase in Temperature from AIMDs Dissipating Endogenous Heat  comments 
formats

ElectroCore’s Noninvasive Vagus Nerve Stimulation – An Interesting Challenge to Implantable VNS Systems

Surgically accessing the Vagus Nerve is not trivial, and implanting a VNS system involving cuff electrodes is risky and recovery is lengthy.  Enter ElectroCore Medical of Bernards Township, New Jersey – it is developing non-invasive VNS therapies that treat or prevent symptoms of serious headache conditions, including migraines and cluster headaches, and bronchoconstriction including asthma and chronic obstructive

 
 Share on Facebook Share on Twitter Share on Reddit Share on LinkedIn
Comments Off on ElectroCore’s Noninvasive Vagus Nerve Stimulation – An Interesting Challenge to Implantable VNS Systems  comments 
formats

Interesting 2012 Presentation by Setpoint Medical on Neuromodulation for Treating Chronic Inflammatory Diseases

I found online the PowerPoint presentation for: R Zitnik, Y Levine, M Faltys, T Arnold, “Harnessing the Inflammatory Reflex: Using Neuromodulation as a Novel Approach to Treat Chronic Inflammatory Diseases”, North American Neuromodulation Society Meeting 2012. The presentation shows some preliminary animal results, presents an artist’s conception of the implantable system, and concludes as follows:

 
 Share on Facebook Share on Twitter Share on Reddit Share on LinkedIn
Comments Off on Interesting 2012 Presentation by Setpoint Medical on Neuromodulation for Treating Chronic Inflammatory Diseases  comments 
formats

Cyberonics Reports 12.4% Increase in VNS Sales for Fiscal Q1 2014

Net product sales increased 12.4% to $67.4 million in the first fiscal quarter ended July 26 for Cyberonics, Inc. of Houston, TX. Including license revenue, sales were up 14.2% overall, with Europe in particular contributing a strong performance. Diluted earnings per share were adjusted by $0.17 cents due to a litigation settlement. According to the

 
 Share on Facebook Share on Twitter Share on Reddit Share on LinkedIn
Comments Off on Cyberonics Reports 12.4% Increase in VNS Sales for Fiscal Q1 2014  comments