Long-Term Medtronic Slogan Registry First To Fanfare How Implantable Passion Devices Employment In Real-World Clinical Practice
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The fundamental results from the Medtronic Inc., (NYSE: MDT) OMNI Glance at were released at Feelings Rhythm 2009, the annual congress of the Affection Rhythm Society, revealing that one out of six patients with implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy-defibrillators (CRT-Ds) to prevent sudden cardiac arrest (SCA), received potentially life-saving medical therapy - either in the die of anti-tachycardia pacing (ATP) or a shock for dangerously rapid emotions rhythms - within a extent of two elderliness following their implant. Further, the study showed that patients received therapy at comparable rates, regardless of whether they meet ongoing medical country guidelines.
The OMNI Recite is the first large-scale, longitudinal registry to pursue nearly 3,000 real-world device patients. This analysis includes 1,620 patients who received devices for meaningful prevention of SCA, 993 of whom meet contemporary guidelines, and 389 patients that complete not. Patients among both groups received therapy at roughly the equivalent rate. And among those who received therapy (n=172, morals group; 69, non-guideline group):
- Sixty-six percent of patients among the criterion group, and 71 percent among the non-guideline battery received ATP therapy
- Thirty-four percent of patients among the guideline group, and 29 percent among the non-guideline group received a shock
While OMNI researchers spot that physicians may interpret the medical guidelines differently to drive definite treatment decisions for their patients, OMNI was not designed to assess why patients who conformed or effect not accommodated guidelines received devices from their doctors.
"We are pleased to be able to share the first wave of results from the five-year, post-market observational study, which bring a better belief of how Medtronic devices may save lives in real-world clinical settings," said David Steinhaus, M.D., vise president and medical employer of Cardiac Rhythm Disease Management at Medtronic.
"This glance at and these insights are a direct conclusion of Medtronic's commitment to scientific proof and clinical outcomes, and specifically, who testament benefit most from our therapies," Dr. Steinhaus continued.
About the OMNI Study
- The purpose of OMNI is to determine how ICDs/CRTs and device-based diagnostics are used to treat and monitor life-threatening arrhythmias in real-world influential and secondary prevention patients.
- OMNI began in 2005, the corresponding year in which Medtronic dedicated two million dollars to support a separate, federally-mandated registry of defibrillator patients that was developed to associate further evidence to bedding Coverage with Evidence Enlargement (CED) questions posed by Centers for Medicare and Medicaid Services (CMS) regarding a particular subgroup of patients. Additional conversation from OMNI addresses these questions, showing no heavy difference between the percentage at which CED and non-CED patients received therapy. Insights into which of these patients with a love condition called non-ischemic dilated cardiomyopathy received device therapy were observed and warrant very analysis.
- OMNI is expected to be exhaustive in 2012; Medtronic will release extra interim results upon availability.
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