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 Archive for category "Therapies" (Page 2)
formats

Abrupt Increase in Thoratec HeartMate II LVAD Thrombosis Reported in NEJM

A study published on Nov 27, 2013 in the New England Journal of Medicine reports on a sudden increase in the incidence of pump thrombosis with the Thoratec HeartMate II LVAD. The study shows an unexplained increase in thrombosis when comparing LVAD patients at three centers from January 2004 to March 2011 vs. those implanted March

 
 Share on Facebook Share on Twitter Share on Reddit Share on LinkedIn
Comments Off on Abrupt Increase in Thoratec HeartMate II LVAD Thrombosis Reported in NEJM  comments 
formats

EndoStim’s LES System Approved in Argentina for GERD Treatment

EndoStim announced that Argentina’s National Administration of Drugs, Food and Medical Technology (ANMAT) approved its Lower Esophageal Sphincter (LES) Stimulation System for Gastroesophageal Reflux Disease (GERD). EndoStim is currently available in Europe, Asia and several other countries in Latin America such as Chile and Colombia.  

 
 Share on Facebook Share on Twitter Share on Reddit Share on LinkedIn
Comments Off on EndoStim’s LES System Approved in Argentina for GERD Treatment  comments 
formats

European Heart Rhythm Association Issues Very Interesting Report on New Devices for the Treatment of Heart Failure

  A position paper was published yesterday by the European Heart Rhythm Association reporting on the performance of new devices for the treatment of heart failure (HF). The report has been endorsed by the Heart Failure Association. The abstract for the paper titled “New devices in heart failure: an European Heart Rhythm Association report” reads:

 
 Share on Facebook Share on Twitter Share on Reddit Share on LinkedIn
Comments Off on European Heart Rhythm Association Issues Very Interesting Report on New Devices for the Treatment of Heart Failure  comments 
formats

NanoWattICs Establishes Working Relationship with Rosellini Scientific to Develop Suite of Neurostimulation Devices

ASIC designer NanoWattICs (Uruguay) and Rosellini Scientific (Dallas, TX) have announced they have entered into a collaborative relationship for the development of a suite of neurostimulation devices comprising implantable, wireless and non-invasive technologies.  From the press release: Rosellini Scientific, LLC (“Rosellini Scientific”; Dallas, TX, USA) and NanoWattICs SRL (“NanoWattICs”; Montevideo, UY) are pleased to formally announce

 
 Share on Facebook Share on Twitter Share on Reddit Share on LinkedIn
Comments Off on NanoWattICs Establishes Working Relationship with Rosellini Scientific to Develop Suite of Neurostimulation Devices  comments 
formats

Medtronic Advisa and Revo MRI SureScan Pacemakers Delays Atrial Fibrillation Disease Progression

Results for the MINERVA Trial were presented at the AHA Meeting, showing that  Medtronic Advisa and Revo MRI(TM) SureScan(TM) pacemakers reduce the progression of permanent AF by 61%.  According to the press release: Presented as a late breaking clinical trial at the American Heart Association’s Scientific Sessions 2013, the MINERVA (MINimizE Right Ventricular pacing to prevent Atrial

 
 Share on Facebook Share on Twitter Share on Reddit Share on LinkedIn
Comments Off on Medtronic Advisa and Revo MRI SureScan Pacemakers Delays Atrial Fibrillation Disease Progression  comments 
formats

Medtronic Reports CRM AIMD Sales Trend Showing Stabilization + Strong Earnings from Neuromodulation AIMDs

Medtronic released today its earning reports for the second quarter of fiscal year 2014, which ended October 25, 2013. Medtronic states in the press release: “Second quarter revenue from Implantable Cardioverter Defibrillators (ICDs) was $713 million, an increase of 4 percent on a constant currency basis in a market that continues to show a trend

 
 Share on Facebook Share on Twitter Share on Reddit Share on LinkedIn
Comments Off on Medtronic Reports CRM AIMD Sales Trend Showing Stabilization + Strong Earnings from Neuromodulation AIMDs  comments 
formats

NeuroPace Receives FDA PMA Approval for for the RNS System to Treat Refractory Partial Epilepsy

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. On November 14, 2013, NeuroPace has now received FDA pre-market approval for the NeuroPace RNS System as a treatment for adults with partial onset

 
 Share on Facebook Share on Twitter Share on Reddit Share on LinkedIn
Comments Off on NeuroPace Receives FDA PMA Approval for for the RNS System to Treat Refractory Partial Epilepsy  comments 
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

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

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