Bionic Vision Australia researchers announced on August 30, 2012 that they successfully performed the first implantation of an early prototype bionic eye with 24 electrodes.
According to the press release:
Category Archives: Therapies
AIMDs classified according to general type of therapy
One for History Buffs: Pacemaker Made in Brasil
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.
St. Jude Medical Receives CE Mark Approval of Eon Mini to Treat Chronic Migraine
St. 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.”
Boston Scientific Receives FDA Approval of S-ICD® for Patients at Risk of SCA
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.
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 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.
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.
Nevro Receives FDA Approval to Initiate Trial of its High-Frequency Spinal Cord Stimulation Therapy
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.
FDA Approves St. Jude’s Assura™ ICDs That Reduce Inappropriate Shocks
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:
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.
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 Starts Trial of Accent MRI Pacemaker and Tendril MRI Lead
Image Credit: St. Jude Medical
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 Pacemaker system from St. Jude Medical offers an advanced pacing platform that provides wireless telemetry and algorithms to help address individual patient conditions.
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 a distributor in Italy of Medtronic.
Biotec developed the first pacemaker VVIR based on physiological changes in thoracic impedance due to respiration. (Biotec RDP-3)
Biotec-Bologna was acquired by Medtronic in August 1985.”
Thank you Paolo!
Monash University in Australia Starts Test of Direct-to-Brain Visual Prosthesis Chips
Image Credit: Monash Vision Group, Monash University, Australia
Engineers from the Monash Vision Group (MVG) have begun trialling the ASICs for a direct-to-brain visual prosthesis that is expected to enter human clinical trials in 2014.
The prosthesis will consist of a tiny camera mounted into a pair of glasses, which acts as the retina; a pocket processor, which takes the electronic information from the camera and converts it into signals enabling the brain to build up a visual construct; and cortical implants of several tiles which will be the portal for the stimulation of the visual cortex. Continue reading
John Hopkins Researcher Develops New Early-Warning Seizures Detector with Low False-Positive Rate
Johns Hopkins’ Sridevi V. Sarma, an assistant professor of biomedical engineering, has devised new seizure detection software that, in early testing, significantly cuts the number of unneeded brain-stimulation therapy that an epilepsy patient would receive.
According to Sarma, “These devices use algorithms—a series of mathematical steps—to figure out when to administer the treatment,” Sarma said. “They’re very good at detecting when a seizure is about to happen, but they also produce lots of false positives, sometimes hundreds in one day. If you introduce electric current to the brain too often, we don’t know what the health impacts might be. Also, too many false alarms can shorten the life of the battery that powers the device, which must be replaced surgically.” Continue reading
St. Jude Seeks Retraction of Heart Rhythm Journal Manuscript by Dr. Robert Hauser Regarding the Failure of Riata and Riata ST Implantable Cardioverter-Defibrillator Leads
St. Jude announced it is seeking a retraction of the manuscript accepted for publication in the Heart Rhythm Journal by Dr. Robert Hauser, et al., titled, “Deaths Caused by the Failure of Riata and Riata ST Implantable Cardioverter-Defibrillator Leads.” St. Jude claims that the research performed by Hauser undercounted and excluded MAUDE data reports for Medtronic product resulting in substantial factual errors.
According to the press release: Continue reading
St. Jude Warns Physicians of Potential Problem with QuickSite and QuickFlex LV CRT Leads
Image Credit: St. Jude Medical
St. Jude announced it is proactively informing physicians about visual observations of externalized conductors on the silicone end of QuickSite® and QuickFlex® Left-Ventricular Leads, used to connect Cardiac Resynchronization Therapy devices to the heart.
The announcement noted that there have been no reports of patient injury or loss of therapy due to externalized conductors in these leads, but as a conservative measure, St. Jude Medical is communicating with physicians about the incidence rate so they have the most updated lead performance information with which to make important patient care decisions.
According to the announcement, “St. Jude Medical has confirmed 39 cases of externalized conductors, out of 171,000 QuickSite and QuickFlex leads sold worldwide, resulting in a current reported incidence rate of 0.023 percent, or 2.3 in 10,000. Because these leads continue to function normally, the company expects that this rate is under-reported. Based on an analysis of leads returned to the company and recent fluoroscopic images of implanted leads still in clinical use, St. Jude Medical estimates that 3 to 4 percent of QuickSite and QuickFlex leads may exhibit externalized conductors. As a result of this estimated rate, the company felt it was prudent to communicate with physicians about the externalized conductors at this time.”
St. Jude also announced they will no longer sell these lead models.