Sorin announced it received U.S. Food and Drug Administration (FDA) conditional approval for its Investigational Device Exemption (IDE) application and clinical trial protocol for RESPOND CRT. The trial will study the safety and effectiveness of the innovative SonR cardiac resynchronization therapy (CRT) optimization system in patients with advanced heart failure. RESPOND CRT is a multi-center,
Biotronik announced that it had received CE-approval for the world’s first DF4 ICD/CRT-D series approved for MRI. In addition, this series contains one of the world’s smallest ICDs– the Iforia single chamber ICD. Aside from featuring ProMRI®technology, which allows patients to undergo potentially life saving MRI scans, Iforia also includes the industry standard DF4 connector
Boston Scientific has received CE Mark approval for increased longevity projections for the INCEPTA™, ENERGEN™, PUNCTUA™, COGNIS® and TELIGEN® implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). The longevity projections are based on data submitted to the European authorities and vary for each device dependent on the model type and settings. Projected device
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.
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
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.
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
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
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
St. Jude Medical announced that clinical findings on quadripolar pacing will be presented at the 61st Annual Scientific Sessions of the American College of Cardiology (ACC, Chicago, March 24-27 2012). According to St. Jude’s announcement, quadripolar pacing allows physicians the ability to use multisite left-ventricular (LV) pacing. Studies that examined the role of multisite pacing in improving hemodynamics and
Medtronic today announced the receipt of CE Mark and launch of the CapSure Sense MRI™ SureScan® pacing leads, which are approved for use during MRI procedures. The newly approved leads are the smallest MR–Conditional leads available in the world with a 5.3 French isodiametric lead body. The new leads are passive-fixation leads. Previously approved Medtronic MR–Conditional leads
My friend and colleague Dr. Irit Yaniv alerted me to this iPhone app that was just released. It is an implantable pacemaker and defibrillator database that, according to its author, displays up to 70 parameters for each model, includes battery and longevity data, and links directly to product manuals.
In 1965, Australian medical device pioneer Noel Gray established Telectronics – Australia’s first manufacturing facility for producing pacemakers that were designed in-house. Telectronics was an innovative developer, achieving some major successes in the early cardiac pacing field, for example, Telectronics’ leads allowed narrowing the pacing pulse to its current nominal of 0.5 milliseconds; encapsulating the pacemaker in titanium
Elema-Schoenander and the Very First Human Implants of a Pacemaker in Sweden (1958) and Uruguay (1960)
This is a picture of the first pacemaker to be implanted in a human patient. It was developed by Dr. Rune Elmqvist (1906–1996), a physician by training, but working for the Swedish company Elema-Schonander as an engineer. Dr. Elmqvist developed the device in cooperation of Åke Senning, senior physician and cardiac surgeon at the Karolinska University Hospital in Solna, Sweden.
This is a hack that combines three of my favorite passions: pacemakers, photography, and coffee! I took this photograph by feeding the output of an infrared barrier to the atrium input of an old DDD pacemaker, setting an appropriate AV delay, and using the ventricular output to trigger a camera flash (via a optoisolator). In