The device, the Na**stim from St. Jude Medical, which only measures 6mm in diameter and 42mm in length, can be Implanted into either*side of the heart using a catheter inserted via*the leg arteries, similar to how stents are currently placed. Moreover, unlike traditional pacemakers, the device does **t need an external generator or wires to function. Instead, a small battery with an estimated lifetime of 15 years is built into the device.
“This is a**ther landmark in the development of pacemakers” said*Dr. Christopher Granger of the American Heart Association, who was **t part of the new study. However, he cautions*that more testing needs to be done before the device can function well in patients.*The Pacemaker has already been approved for use in Europe and is to be submitted to the US Food and Drug Administration (FDA) soon.
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The leadless Pacemaker was successfully Implanted in 504 of the 526 patients in the total cohort (95.8%). The intention-to-treat primary efficacy end point was met in 270 of the 300 patients in the primary cohort (90.0%; 95% confidence interval [CI], 86.0 to 93.2, P=0.007), and the primary safety end point was met in 280 of the 300 patients (93.3%; 95% CI, 89.9 to 95.9; P
09-11-2015, 09:44 PM
New Wireless Pacemaker Implanted Without Surgery, Found Safe in Clinical Study
A*study, published in New England Journal of Medicine, describes the use of a new Pacemaker that can be Implanted into the heart Without the necessity for surgery*to test its safety and efficacy in fragile patients who require permanent pacing for **rmal functioning of the heart.
The device, the Na**stim from St. Jude Medical, which only measures 6mm in diameter and 42mm in length, can be Implanted into either*side of the heart using a catheter inserted via*the leg arteries, similar to how stents are currently placed. Moreover, unlike traditional pacemakers, the device does **t need an external generator or wires to function. Instead, a small battery with an estimated lifetime of 15 years is built into the device.
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