Boston Scientific has received CE Mark approval for the new EMBLEM™ MRI Subcutaneous Implantable Defibrillator (S-ICD) System, as well as magnetic resonance (MR) conditional labeling for all previously implanted EMBLEM S-ICD Systems.
The EMBLEM S-ICD Systems are treatment options for patients at risk of sudden cardiac arrest (SCA) that leave the heart and vasculature untouched, reducing the risk of complications associated with transvenous implantable cardioverter-defibrillators (TV-ICDs). Initial market release of the new EMBLEM MRI S-ICD System has begun in a small number of European centers with a broad European launch scheduled for early this summer.
In Europe, the EMBLEM MRI S-ICD System joins the growing family of ImageReady™ MR-conditional devices, all of which are labeled safe for use in a magnetic resonance image setting when conditions of use are met. Patients receiving the EMBLEM MRI S-ICD System as well as patients who previously were implanted with an EMBLEM S-ICD System are now able to undergo full-body MR scans safely in 1.5 Tesla environments when conditions of use are met.
"These approvals give reassurance to physicians and their patients that they have access to any future MR scan needs, and underscores the Boston Scientific commitment to gain MR-conditional labeling on high-voltage devices that are being implanted today," said Kenneth Stein, M.D., chief medical officer, Rhythm Management, Boston Scientific. "Further, the EMBLEM S-ICD System is a compelling treatment option for the majority of ICD-indicated patients that provides protection from cardiac arrest without invading the heart and blood vessels."
The EMBLEM MRI S-ICD System also includes two new features, SMART Pass technology and Atrial Fibrillation (AF) Monitor™. The SMART Pass technology will help ensure patients receive therapy from the device only when necessary by enhancing the INSIGHT™ Algorithm, which identifies and classifies a heart rhythm for effective arrhythmia treatment. This novel feature will also be added to previously implanted EMBLEM S-ICD Systems through a software update. The AF Monitor feature of the EMBLEM MRI S-ICD System is a new detection tool designed to alert physicians after the identification of AF so they can make more informed treatment decisions for their patients.
For more information on the EMBLEM S-ICD Systems please visit www.sicdsystem.com.
Showing posts with label Defibrillator. Show all posts
Showing posts with label Defibrillator. Show all posts
18 April, 2016
St. Jude Launches First US Implants of MultiPoint Pacing
St. Jude received U.S. Food and Drug Administration (FDA) approval of the company’s proprietary, first-to-market MultiPoint™ Pacing technology and today announced the U.S. launch and first U.S. implants of the Quadra Assura MP™ cardiac resynchronization therapy defibrillator (CRT-D). MultiPoint Pacing technology is a revolutionary approach designed for CRT patients who are not responsive to other pacing options.
The first implant took place at Saint Francis Hospital in Hartford, Conn. Speaking about the opportunity, Dr. Neal Lippman, electrophysiologist with Arrhythmia Consultants of Connecticut at Saint Francis said, “We are now able to offer St. Jude Medical’s new MultiPoint Pacing technology for our patients whose heart failure condition is difficult to manage. It is important for us to have this option to individualize patient care and help improve response to therapy.”
Despite the improvements in patient outcomes seen with quadripolar CRT technology, a small, but important group of patients do not respond optimally to the therapy. Importantly, these “non-responders” to CRT cannot be identified at the time of implant and how effective the therapy will be in addressing an individual patient’s heart failure symptoms can be unpredictable. MultiPoint Pacing technology offers physicians a new set of tools that allow for individualized patient therapy with the goal of optimizing their response to CRT.
St. Jude Medical developed and launched the industry’s first quadripolar pacing system in the United States in 2011 featuring four pacing electrodes, offering physicians the ability to effectively and efficiently manage the ever-changing needs of patients with heart failure. The Quartet LV lead design allows the physician to implant the lead in the most stable position without making trade-offs in electrical performance; this also reduces the likelihood of costly and invasive lead revision through a second intervention procedure. Adding MultiPoint Pacing technology and additional lead sizes to the quadripolar offerings provides physicians more advanced options to optimize CRT performance, such as improving hemodynamics, resynchronization and reverse remodeling of the heart.
The first implant took place at Saint Francis Hospital in Hartford, Conn. Speaking about the opportunity, Dr. Neal Lippman, electrophysiologist with Arrhythmia Consultants of Connecticut at Saint Francis said, “We are now able to offer St. Jude Medical’s new MultiPoint Pacing technology for our patients whose heart failure condition is difficult to manage. It is important for us to have this option to individualize patient care and help improve response to therapy.”
Despite the improvements in patient outcomes seen with quadripolar CRT technology, a small, but important group of patients do not respond optimally to the therapy. Importantly, these “non-responders” to CRT cannot be identified at the time of implant and how effective the therapy will be in addressing an individual patient’s heart failure symptoms can be unpredictable. MultiPoint Pacing technology offers physicians a new set of tools that allow for individualized patient therapy with the goal of optimizing their response to CRT.
St. Jude Medical developed and launched the industry’s first quadripolar pacing system in the United States in 2011 featuring four pacing electrodes, offering physicians the ability to effectively and efficiently manage the ever-changing needs of patients with heart failure. The Quartet LV lead design allows the physician to implant the lead in the most stable position without making trade-offs in electrical performance; this also reduces the likelihood of costly and invasive lead revision through a second intervention procedure. Adding MultiPoint Pacing technology and additional lead sizes to the quadripolar offerings provides physicians more advanced options to optimize CRT performance, such as improving hemodynamics, resynchronization and reverse remodeling of the heart.
The press release can be found from St. Jude website by clicking here.
05 April, 2016
St. Jude Announces CE Approval of Quadripolar Pacing Leads
St. Jude announced CE Mark approval and launch of three new Quartet™ left ventricular (LV) leads, offering additional electrode spacing options and one new lead shape. The additional spacing combinations are aimed to more effectively target the individual cardiac anatomies of patients who need support from cardiac resynchronization therapy pacemakers (CRT-P) and defibrillators (CRT-D).
Studies have shown that CRT can improve the quality of life for many patients with heart failure. CRT resynchronizes the beating of the heart's lower chambers (ventricles), which often beat out of sync in heart failure patients. The addition of MultiPoint Pacing™ technology enables physicians to program a single Quartet LV lead to pace multiple sites on the left side of the heart, giving the clinician more choices to improve patient response to therapy and reducing the likelihood of costly and invasive lead revision through a second intervention procedure.
The newly-approved additional quadripolar lead options are used with next-generation MultiPoint Pacing technology, which enables physicians to pace multiple locations on the left side of the heart and provide physicians a new option for patients who haven’t responded to CRT. The expanded selection of quadripolar pacing leads makes the St. Jude Medical quadripolar lead portfolio the broadest on the market and allows for enhanced individualization of CRT. The new leads are designed based on the company’s first-to-market proven quadripolar LV lead technology and include additional spacing options on two new S-shape and one new double-bend lead designs.
Some of the newly approved products are also magnetic resonance (MR) – conditional, including the Quadra Assura™ CRT-D and Quadra Assura MP™ CRT-D with MultiPoint™ Pacing. Additionally, physicians will be able to quickly customize therapy using the Auto VectSelect Quartet™ Test, which is designed to automatically guide programming of the most appropriate therapy options available and streamline workflow.
Studies have shown that CRT can improve the quality of life for many patients with heart failure. CRT resynchronizes the beating of the heart's lower chambers (ventricles), which often beat out of sync in heart failure patients. The addition of MultiPoint Pacing™ technology enables physicians to program a single Quartet LV lead to pace multiple sites on the left side of the heart, giving the clinician more choices to improve patient response to therapy and reducing the likelihood of costly and invasive lead revision through a second intervention procedure.
The newly-approved additional quadripolar lead options are used with next-generation MultiPoint Pacing technology, which enables physicians to pace multiple locations on the left side of the heart and provide physicians a new option for patients who haven’t responded to CRT. The expanded selection of quadripolar pacing leads makes the St. Jude Medical quadripolar lead portfolio the broadest on the market and allows for enhanced individualization of CRT. The new leads are designed based on the company’s first-to-market proven quadripolar LV lead technology and include additional spacing options on two new S-shape and one new double-bend lead designs.
Some of the newly approved products are also magnetic resonance (MR) – conditional, including the Quadra Assura™ CRT-D and Quadra Assura MP™ CRT-D with MultiPoint™ Pacing. Additionally, physicians will be able to quickly customize therapy using the Auto VectSelect Quartet™ Test, which is designed to automatically guide programming of the most appropriate therapy options available and streamline workflow.
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