St. Jude Medical today announced CE Mark approval and European launch of its Allure Quadra™ Cardiac Resynchronization Therapy Pacemaker (CRT-P), which brings the quadripolar lead technology to the pacemaker market for the first time. According to the press release: “Quadripolar leads allow for increased implant efficiencies, which clinical data indicates can result in fewer surgical revisions.
Comments Off 
St. Jude’s Q1 2013 AIMD Results: CRM Down 7%, Neuromodulation Down 4%
St. Jude Medical announced sales results for Q1 2013. AIMD results from their press release: “Cardiac Rhythm Management (CRM) Total CRM sales, which include implantable cardioverter defibrillator (ICD) and pacemaker products, were $678 million for the first quarter of 2013, an 8 percent decrease compared to the first quarter of 2012. After adjusting for the
Comments Off
St. Jude’s DBS Systems First to Receive CE Mark for Both Primary and Secondary Dystonia
St. Jude Medical announced CE Mark approval of its Brio™, Libra™ and LibraXP™ deep brain stimulation (DBS) systems for managing the symptoms of intractable primary and secondary dystonia, a neurological movement disorder that causes a person’s muscles to contract and involuntarily spasm, reducing the ability to control movement. This approval represents the first by a
Comments Off
St. Jude Releases 2012 Year-End Results: CRM Down 6%, Neuromodulation Up 1%
St. Jude Medical today reported sales and net earnings for the fourth quarter and year ended December 29, 2012. According to the announcement: “Total CRM sales, which include implantable cardioverter defibrillator (ICD) and pacemaker products, were $682 million for the fourth quarter of 2012, a 6 percent decrease compared to the fourth quarter of 2011.
Comments Off
St. Jude’s Q3 2012 AIMD Results: CRM Maintains Downward Trend, Neuromodulation Steady
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
Comments Off
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
Comments Off
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
Comments Off
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
Comments Off
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
Comments Off
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
Comments Off
St. Jude Warns Physicians of Potential Problem with QuickSite and QuickFlex LV CRT Leads
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
Comments Off
St. Jude Medical Announces Clinical Benefits of Quadripolar CRT Pacing at ACC
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
Comments Off
The Australian Pacemaker: Telectronics (1965-1995)
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
DF-4 Connectors for Implantable Cardioverter Defibrillators Enter Use in the US
The DF-4 Connector was recently introduced by a joint group of CRM companies, physicians, and regulatory agencies as a way of easing the implant of ICDs by reducing defibrillation connections from three to one and by minimizing the number of set screws. Prior to the development of the DF-4, traditional high-voltage connector systems required up to three connections.
Comments Off
St. Jude Medical’s Active Implantable Sales for 2011: CRM Down 3%, Neuromodulation Up 8%
St. Jude Medical today reported sales and net earnings for the fourth quarter and year ended December 31, 2011. From the press release: “Cardiac Rhythm Management Total CRM sales, which include implantable cardioverter defibrillator (ICD) and pacemaker products, were$728 million for the fourth quarter of 2011, a 4 percent decrease compared to the fourth quarter of 2010. After
Comments Off
