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

Category Archives: AIMD Companies

Biotronik Launches Implantable BioMonitor for Monitoring Arrhythmias

Posted on by Posted in Atrial Flutter/Fib, Biotronik, Dementia, ECG Monitoring, Tachycardia, Telemetry

Biotronik BioMonitor to diagnose arrhythmias. David Prutchi PhD www.implantable-device.comBiotronik announced the European market release of BioMonitor®, an implantable cardiac device designed for the highly accurate and reliable monitoring and management of patients with atrial fibrillation (AF) or unexplained syncope.

According to Biotronik’s press release:

“BioMonitor® is a subcutaneous implantable leadless cardiac monitor for the long-term continuous remote monitoring of patients with arrhythmias such as AF, bradycardia, sudden rate drop, asystole and tachycardia.

As sensitivity and specificity are essential in the detection of arrhythmias such as AF, BIOTRONIK has developed ClearSense Technology with a unique three-vector signal detection that produces highly precise and reliable arrhythmia monitoring.

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St. Jude’s Q3 2012 AIMD Results: CRM Maintains Downward Trend, Neuromodulation Steady

Posted on by Posted in AIMD Business, St. Jude Medical

St. Jude announced today its third quarter 2012 results.  From the press release:

“Total CRM sales, which include implantable cardioverter defibrillator (ICD) and pacemaker products, were $691 million for the third quarter of 2012, an 8 percent decrease compared with the third quarter of 2011. Total CRM sales for the third quarter decreased 4 percent after adjusting for the impact of foreign currency.

Of that total, ICD product sales were $412 million in the third quarter, a 7 percent decrease compared with the third quarter of 2011. On a constant currency basis, total ICD sales declined 4 percent from the prior year.

Third quarter pacemaker sales were $279 million, a 9 percent decrease compared to the third quarter of 2011. After adjusting for the impact of foreign currency, pacemaker sales decreased 4 percent.”

…

“St. Jude Medical sales of neuromodulation products were $101 million in the third quarter of 2012, down 1 percent from the comparable quarter of 2011. Revenue for the third quarter increased 2 percent after adjusting for the impact of foreign currency”

 

Boston Scientific Receives CE Mark for RELIANCE® 4-FRONT™ Defibrillation Lead

Posted on by Posted in Boston Scientific, Bradycardia, Cardiac Pacing, Cardioversion/Defibrillation, Heart Failure (CHF), Tachycardia
Boston Scientific ENDOTAK RELIANCE® 4-SITE™ Defibrillation Lead www.implantable-device.com David Prutchi, Ph.D.

Image Credit: Boston Scientific

Boston Scientific has received regulatory approval to market the RELIANCE® 4-FRONT™ lead, its next generation implantable defibrillation lead now available in Europe and Asia.   According to the press release, “The RELIANCE 4-FRONT lead is built upon the demonstrated performance and reliability of the RELIANCE lead platform with design enhancements intended to simplify the implant procedure. With more than 350,000 implants worldwide, RELIANCE leads have demonstrated a 98.9 percent survival probability at 8 years.

“Leveraging the RELIANCE platform, we made a series of targeted design enhancements with RELIANCE 4-FRONT to improve and simplify implantation,” said Kenneth Stein, M.D., chief medical officer of Boston Scientific’s Cardiac Rhythm Management Group. “RELIANCE 4-FRONT represents our continued dedication to product innovation to meet the needs of patients and physicians.”

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Boston Scientific Receives CE Mark of Vercise™ Deep Brain Stimulation System

Posted on by Posted in Boston Scientific, Brain Stimulation, Neural Stimulation, Parkinson's Disease
Boston Scientific Vercise DBS System www.implantable-device.com David Prutchi, Ph.D.

Image Credit: Boston Scientific

Boston Scientific Corporation received CE Mark approval for use of its Vercise™ Deep Brain Stimulation (DBS) System for the treatment of Parkinson’s disease. The Vercise DBS System is the first and only commercially available DBS system to incorporate multiple independent current control, which is designed to selectively stimulate targeted areas in the brain. This system is an innovative technology that is designed to provide physicians fine control of stimulation.

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One for History Buffs: Pacemaker Made in Brasil

Posted on by Posted in Bradycardia, Cardiac Pacing, CCC del Uruguay, CCC Medical, Museum

Implantable Pacemaker Made in Brasil. www.implantable-device.com David Prutchi Ph.D.

My friend Daniel Villamil from CCC Medical in Uruguay sent me these pictures of a very unique device in his colection.  It is a late-1960s/early 1970s pacemaker made in Sao Paulo, Brasil.

UPDATE Oct 3, 2012:

CCC’s CEO Julio Arzuaga recalled that this pacemaker was manufactured in the early 1960s by the Instituto de Cardiologia Dante Pazzanese in Sao Paulo, Brasil.  The physicians leading the pacemaker team were Dr. Decio Kormann and Dr. Adib Jatene.

Dr. Orestes Fiandra used to implant these Brasilian pacemakers in Uruguay.  However, they were not very reliable.  For this reason, and with help from Drs. Kormann and Jatene, Dr. Fiandra started CCC del Uruguay as a more industrial environment for the production of pacemakers.

Implantable Pacemaker Made in Brasil. www.implantable-device.com David Prutchi Ph.D.

St. Jude Medical Receives CE Mark Approval of Eon Mini to Treat Chronic Migraine

Posted on by Posted in Migraine, Neural Stimulation, Occipital Nerve Stimulation, St. Jude Medical

St Jude Medical Eon and Eon Mini Spinal Cord StimulatorsSt. Jude Medical announced it has received European CE Mark approval of its Eon™ family of neurostimulators for treating patients with intractable chronic migraine.

According to the press release:

“Intractable chronic migraine is one of the most difficult-to-treat headache disorders,” said Professor Gennaro Bussone, M.D., head of the Neurological Department at Istituto Besta in Milan Italy. “By definition, people living with this condition are spending half their month living with debilitating headaches. This therapy expands our options in helping manage patients who suffer with disabling chronic migraine symptoms.”

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

Posted on by Posted in Boston Scientific, Cameron Health, Cardioversion/Defibrillation, Tachycardia

 

Cameron Health S-ICD subcutaneous defibrillator

Image Credit: Boston Scientific

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 placed into the heart.

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Human Implants of Vestibular Prostheses at the Maastricht University Medical Center

Posted on by Posted in Cochlear Ltd., Cochlear Stimulation, Med-El, Meniere's Disease, Vertigo, Vestibular Stimulation

Vestibular Prosthesis implanted at the Maastricht University Medical Center www.implantable-device.com David Prutchi Ph.D.

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 integrate the information from these implants to restore balance to the patients.

There have been a number of prior human implants of different vestibular devices.   For example, in 2010 Jean-Philippe Guyot implanted a vestibular nerve stimulation device in a human subject. Their work was published in March 2011. The device was a modified Med-El cochlear implant using an electrode that was implanted near the left posterior ampullary nerve. In addition, Washington University implanted a device based on a similar approach (a modified Nucleus device by Cochlear Ltd.) on Oct. 21, 2010.  It must be noted however that these prior devices do not sense head motion, but were designed to override abnormal vestibular signals.  On the other hand, from the sketchy details that have appeared, it seems that the devices implanted in Maastricht are the first true vestibular prostheses capable of responding to orientation and acceleration.

 

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

Posted on by Posted in Nerve Blocking, Neural Stimulation, Nevro, Pain, Spinal Cord Stimulation
Nevro Senza Implantable Spinal Cord Stimulator for Back and Leg Pain

Image Source: Nevro's Website

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.

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

Posted on by Posted in Cardioversion/Defibrillation, Heart Failure (CHF), St. Jude Medical, Tachycardia
St Jude Medical's Assura series of implantable defibrillators and CRT-Ds www.implantable-device.com David Prutchi, Ph.D.

Image Credit: St. Jude Medical

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 with these devices.

According to St. Jude’s announcement:

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

Posted on by Posted in AIMD Business, EnteroMedics, Obesity, Vagus Nerve Stimulation

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.

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 goal.  EnteroMedics is currently conducting a pivotal trial that is expected to end in Q4 2012. EnteroMedics expects to file a premarket approval application with the FDA in the first half of 2013 if the data from the trial is positive.

 

 

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

Posted on by Posted in AIMD Business, St. Jude Medical

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 in the first quarter, a 3 percent decrease compared with the first quarter of 2011. First quarter pacemaker sales were $285 million, a decrease of 4 percent from the comparable quarter of 2011.

St. Jude Medical sales of neuromodulation products were $103 million in the first quarter of 2012, up 12 percent from the comparable quarter of 2011.