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 2012 (Page 2)
formats

Boston Scientific Receives FDA Approval of S-ICD® for Patients at Risk of SCA

  On Sept. 28, 2012 Boston Scientific announced that the FDA granted regulatory approval for its S-ICD® System, the world’s first and only commercially available subcutaneous implantable defibrillator (S-ICD) for the treatment of patients at risk for sudden cardiac arrest (SCA). The S-ICD System sits entirely just below the skin without the need for leads to be

 
 Share on Facebook Share on Twitter Share on Reddit Share on LinkedIn
Comments Off on Boston Scientific Receives FDA Approval of S-ICD® for Patients at Risk of SCA  comments 
formats

Human Implants of Vestibular Prostheses at the Maastricht University Medical Center

Physicians at the Maastricht University Medical Center implanted two patients with vestibular prostheses.  These implants are similar to a cochlear implant, but instead of sound, conveys orientation and acceleration information to the vestibular organ that assists in preserving balance. According to lead implanter Prof. Robert Stokroos, preliminary assessment is promising, and research will be conducted to determine if the brain can

 
 Share on Facebook Share on Twitter Share on Reddit Share on LinkedIn
Comments Off on Human Implants of Vestibular Prostheses at the Maastricht University Medical Center  comments 
formats

TEDxCambridge Talk Calls for Open Data from AIMDs

In this TED talk, Hugo Campos explains his frustration with the fact that his ICD collects data, but he – as a patient – is unable to access these data as a diagnostic tool to help make good choices about eating, exercise and other activities.

 
 Share on Facebook Share on Twitter Share on Reddit Share on LinkedIn
Comments Off on TEDxCambridge Talk Calls for Open Data from AIMDs  comments 
formats

Sequana Medical’s ALFApump® to Manage Ascites

Swiss medical device manufacturer Sequana Medical developed the ALFApump® System to pump fluids accummulated in the abdomen of a patient into the bladder.

 
 Share on Facebook Share on Twitter Share on Reddit Share on LinkedIn
Comments Off on Sequana Medical’s ALFApump® to Manage Ascites  comments 
formats

Nevro Receives FDA Approval to Initiate Trial of its High-Frequency Spinal Cord Stimulation Therapy

Nevro Corp announced that FDA has granted approval for initiation of its SENZA-RCT study, a U.S. prospective, randomized, controlled pivotal clinical trial evaluating the safety and efficacy of Nevro’s high-frequency spinal cord stimulation system for the treatment of chronic pain.

 
 Share on Facebook Share on Twitter Share on Reddit Share on LinkedIn
1 Comment  comments 
formats

Boston Scientific’s Proprietary Batteries Projected to Give >10 Year Longevity to ICDs

Boston Scientific announced today that FDA has approved revised product labeling for  its INCEPTA™, ENERGEN™, PUNCTUA™, COGNIS® and TELIGEN® ICDs and CRT-Ds to reflect increased longevity projections for these devices.  The longevity projections are based on data submitted to the FDA and vary for each device dependent on the model type and settings.

 
 Share on Facebook Share on Twitter Share on Reddit Share on LinkedIn
Comments Off on Boston Scientific’s Proprietary Batteries Projected to Give >10 Year Longevity to ICDs  comments 
formats

FCC Considering Opening Spectrum to Wireless Body Sensors

Reported by dotMedNews.com:  FCC could open spectrum to wireless body sensors May       18, 2012 by Brendon Nafziger, DOTmed News Associate Editor Patients in intensive care units are typically festooned with a mass of monitoring wires, leads, pads and electrodes. Not only is this an infection control hazard, which some researchers estimate costs the industry billions

 
 Share on Facebook Share on Twitter Share on Reddit Share on LinkedIn
Comments Off on FCC Considering Opening Spectrum to Wireless Body Sensors  comments 
formats

Smallest ICD (30cc) – St. Jude’s Ellipse – Receives FDA Approval

St. Jude today announced FDA approval of its Ellipse™ ICD.  The device’s shape was designed with feedback from more than 200 physicians from around the world.  The Ellipse ICD offers physicians unique design advancements, resulting in a high-energy ICD that occupies barely 30cc. According to the announcement, “The Ellipse ICD’s unique shape was conceptualized by physicians during focus groups

 
 Share on Facebook Share on Twitter Share on Reddit Share on LinkedIn
Comments Off on Smallest ICD (30cc) – St. Jude’s Ellipse – Receives FDA Approval  comments 
formats

FDA Approves St. Jude’s Assura™ ICDs That Reduce Inappropriate Shocks

St. Jude Medical today announced FDA approval of its Assura™ portfolio of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).The new implantable defibrillators feature SecureSense™ RV Lead Noise Discrimination, an algorithm that expands the St. Jude Medical ShockGuard® Technology and offers advanced sensing options designed to reduce the incidence of inappropriate shocks for patients

 
 Share on Facebook Share on Twitter Share on Reddit Share on LinkedIn
Comments Off on FDA Approves St. Jude’s Assura™ ICDs That Reduce Inappropriate Shocks  comments 
formats

EnteroMedics Reports $123k Revenue from Sales of its Maestro RC IPG for Treatment of Obesity

Today EnteroMedics recorded revenue for the first time since it was incorporated nearly eight years ago. The company reported revenue of about $123,000 in the first quarter of the year from the sale of its Maestro RC implantable vagus nerve stimulation system for treating obesity. Revenue was generated through sales by its distribution partner in Australia.

 
 Share on Facebook Share on Twitter Share on Reddit Share on LinkedIn
Comments Off on EnteroMedics Reports $123k Revenue from Sales of its Maestro RC IPG for Treatment of Obesity  comments 
formats

Boston Scientific Q1 2012 AIMD Results: CRM Down 10%, Neuromodulation 8% Up

Yesterday Boston Scientific announced financial results for the first quarter ended March 31, 2012.  Sales of Cardiac Rhythm Management devices were $501M vs. $559M for Q1 a year ago, or a decrease of 10%.  Sales of  Neuromodulation devices increased by 8% a year ago from $77M to $84M for Q1.

 
 Share on Facebook Share on Twitter Share on Reddit Share on LinkedIn
Comments Off on Boston Scientific Q1 2012 AIMD Results: CRM Down 10%, Neuromodulation 8% Up  comments 
formats

St. Jude’s Reports Q1 2012 AIMD Sales Results: CRM down 4%, Neuromodulation up 12%

St. Jude Medical today reported sales and net earnings for the first quarter ended March 31, 2012. Total CRM sales, which include ICD and pacemaker products, were $735 million for the first quarter of 2012, a 4 percent decrease compared with the first quarter of 2011.  Of that total, ICD product sales were $450 million

 
 Share on Facebook Share on Twitter Share on Reddit Share on LinkedIn
Comments Off on St. Jude’s Reports Q1 2012 AIMD Sales Results: CRM down 4%, Neuromodulation up 12%  comments 
formats

St. Jude Starts Trial of Accent MRI Pacemaker and Tendril MRI Lead

Today St. Jude announced the first implant in its Accent MRI(R) Pacemaker and Tendril MRI(R) Lead IDE Study (MRI Study). The ultimate goal of the study is to determine if patients with these devices can safely undergo full-body, high resolution Magnetic Resonance Imaging (MRI) scans to better accommodate their medical needs. The investigational Accent MRI

 
 Share on Facebook Share on Twitter Share on Reddit Share on LinkedIn
Comments Off on St. Jude Starts Trial of Accent MRI Pacemaker and Tendril MRI Lead  comments 
formats

Digikon’s History

In response to my post “A Challenge to History Buffs:  Who Was Digikon?“, Paolo Pagani sent me the following message: “Digikon was in the years 1977-1985 the brand name product in Italy by Biotec Biomedical Technologies of Bologna – ITALY. Pacemakers were a Digikon O.E.M. production for the trading company of Milan Italy KONTRON already

 
 Share on Facebook Share on Twitter Share on Reddit Share on LinkedIn
Comments Off on Digikon’s History  comments 
formats

Medtronic Receives FDA Appoval for Expanded Use of CRT-D to Class II HF

Medtronic received FDA approval for the expanded use of CRT-D in mildly-symptomatic heart failure patients.  The expanded indication includes New York Heart Association (NYHA) Class II heart failure patients with a left ventricular ejection fraction (LVEF) of less than or equal to 30 percent, left bundle branch block (LBBB), and a QRS duration greater than

 
 Share on Facebook Share on Twitter Share on Reddit Share on LinkedIn
Comments Off on Medtronic Receives FDA Appoval for Expanded Use of CRT-D to Class II HF  comments