St. Jude Medical today announced the approval of its Protégé™ IPG from the U.S. Food and Drug Administration (FDA). Protégé is the first and only neurostimulation system that allows spinal cord stimulation (SCS) technology upgrades as they are approved to be made via software updates. According to the press release: Chronic pain sufferers implanted with
St. Jude today announced the first U.S. implant in the company’s LEADLESS II pivotal trial designed to evaluate the Nanostim™ leadless pacemaker for FDA approval. The world’s first retrievable, non-surgical pacemaker was implanted at The Mount Sinai Hospital in New York City by Dr. Vivek Reddy. The LEADLESS II pivotal trial is a prospective, non-randomized,
St Jude Medical announced that its Cardiac Rhythm Management sales increased 5 percent on a constant-currency basis over the fourth quarter of 2012. Neuromodulation sales for the same period increased by 2%. According to the press release: Cardiac Rhythm Management Total CRM sales, which include implantable cardioverter defibrillator (ICD) and pacemaker products, were $705 million for
St. Jude announced today that it has launched the SENSE™ Subcutaneous and Epidural Neuromodulation System Evaluation study – a clinical study to evaluate the combination of peripheral nerve field stimulation (PNfS), and spinal cord stimulation (SCS), to determine whether the two therapies together offer more effective management of chronic low back and leg pain than SCS
St. Jude Launches SUNBURST Study to Evaluate New Prodigy Neurostimulator’s Burst Stimulation for Chronic Pain
St. Jude announced today that it has initiated a clinical study of the Prodigy™ neurostimulator, which is the first SCS system able to deliver a proprietary mode of stimulation therapy called burst stimulation. The purpose of the SUNBURST™ (Success Using Neuromodulation with BURST) study is to evaluate whether burst stimulation can be more effective in
From today’s press release: Cardiac Rhythm Management (CRM) Total CRM sales, which include implantable cardioverter defibrillator (ICD) and pacemaker products, were $682 million for the third quarter of 2013, a 1 percent decrease compared to the third quarter of 2012. After adjusting for the impact of foreign currency, total CRM sales were flat. Of that
St. Jude Medical today announced the completion of its acquisition of Nanostim, Inc., a privately-owned developer of miniaturized, leadless pacemakers. The acquisition adds the world’s first and only leadless pacemaker to the St. Jude Medical product portfolio. According to the press release: Unlike conventional pacemakers that require a more invasive surgery, the Nanostim™ leadless pacemaker
Although the FDA advisory panel found CardioMEMS’ CHAMPION HF Pressure Measurement System to be safe, on October 9, 2013, the majority of panel members decided that the implantable sensor monitor to help guide treatment in patients with congestive heart failure is not effective. According to Forbes, one panel member said it was difficult to connect the dots between
From today’s press release: “Cardiac Rhythm Management (CRM) Total CRM sales, which include implantable cardioverter defibrillator (ICD) and pacemaker products, were $718 million for the second quarter of 2013, a 4 percent decrease compared to the second quarter of 2012. After adjusting for the impact of foreign currency, total CRM sales decreased 2 percent. Of
St. Jude Medical today announced CE Mark approval of its next-generation quadripolar device, the Quadra Assura MP™ cardiac resynchronization therapy defibrillator (CRT-D). The device features MultiPoint™ Pacing (MPP) technology that enables physicians to pace multiple locations on the left side of the heart. This gives the clinician more choices to best optimize cardiac resynchronization therapy (CRT)
St. Jude Medical announced FDA approval of its next-generation Ellipse™ and SJM Assura™ portfolio of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). The new devices are designed to lower the risk of lead abrasion and to ensure high-voltage therapy delivery. According to the announcement: The Ellipse and SJM Assura family of devices
St. Jude Medical and privately-held Spinal Modulation, Inc., today announced that they have entered into a series of agreements under which St. Jude Medical made a $40 million equity investment in Spinal Modulation, a company that has developed an innovative neuromodulation therapy that provides a new pain management option for patients with chronic, intractable pain.
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.
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
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