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

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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Cognitive Prosthesis Enhances Short-Term Memory and Decision-Making in Primates

Posted on by Posted in Uncategorized
Cognitive Prosthesis www.implantable-device.com David Prutchi Ph.D.

Image Source: IOP Science

Scientists at Wake Forest University School of Medicine in Winston-Salem, North Carolina reported using a neural implant to stimulate higher-level thinking in monkeys, providing the first demonstration in primates of the sort of brain prosthesis that could eventually help people with damage from dementia, strokes or other brain injuries.  The study was published on Sept. 14 in IOP Publishing’s Journal of Neural Engineering.

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

Posted on by Posted in Uncategorized
Boston Scientific ICD with extended longevity. David Prutchi PhD www.implantable-device.com

Image Credit: Boston Scientific

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.

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FCC Considering Opening Spectrum to Wireless Body Sensors

Posted on by Posted in Uncategorized

FCC Logo www.implantable-device.com David Prutchi PhDReported 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 in treatment expenses, it’s also a hassle – both for the patient and the doctor.
“My problem is I can’t even get my stethoscope on the chest anymore. There’s no room,” Dr. Richard Katz, director of Cardiology at George Washington University Hospital in Washington, D.C., told reporters at a press conference at his hospital Thursday. Continue reading→

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

Posted on by Posted in Uncategorized
St Jude Medical's Ellipse VR - the smallest ICD in the world. www.implantable-device.com David Prutchi, PhD

Image Credit: St. Jude Medical

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 where they crafted in clay their vision for the ideal device design. The physician-inspired shape is unlike any device currently available and designed to increase patient comfort and physician ease-of-use. The angled header and rounded edges were designed to improve the way a lead wraps around the device once connected, which can result in a smaller incision and reduced pocket size for the device.”

 

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.