|World's Smallest Pacemaker, Medtronic Micra TPS, Wins Top European Innovation Award for 2015|
Award Follows Late-breaking Presentation Showing Medtronic Micra Transcatheter Pacemaker
DUBLIN and MILAN - June 24, 2015 - Medtronic plc (NYSE: MDT) today announced that its Micra® Transcatheter Pacing System (TPS) has won the top innovation award for practice improvement at EHRA EUROPACE-CARDIOSTIM 2015 in Milan. The award is selected by an international panel of experts, scientists and physicians who review the competing products and choose the "ultimate innovation."
Today's award follows a late-breaking presentation of study results from the Micra TPS global clinical trial, which demonstrated that the miniaturized pacemaker met its initial safety and performance measures.
At less than one-tenth the size of traditional pacemakers, the Micra TPS provides the most advanced pacing technology available while being cosmetically invisible and small enough to be delivered with minimally invasive techniques through a catheter, and implanted directly into the heart.
Comparable in size to a large vitamin, the Micra TPS does not require the use of wires, known as "leads," to deliver pacing therapy; rather, it is attached to the heart via small tines and delivers electrical impulses that pace the heart through an electrode at the end of the device. Once positioned, the Micra TPS can be repositioned or retrieved, if needed. The device responds to patients' activity levels by automatically adjusting therapy. Unlike traditional pacemakers, the Micra TPS does not require a surgical "pocket" under the skin, so potential sources of complications from this type of implantation are eliminated-as are any visible signs of the device.
The Micra TPS was commercially launched in Europe earlier this month after being awarded CE (Conformité Européenne) Mark based on data from the Medtronic Micra TPS Global Clinical Trial. Micra TPS also is the first transcatheter pacing system to be awarded CE (Conformité Européenne) Mark for 1.5T and 3T full body MRI scanning, providing patients with access to the most advanced imaging diagnostic procedures.
In the United States, the Micra TPS is an investigational device and not yet approved for commercial use.
"We are honored to accept this award on behalf of: the scientists who, through their dedication to innovation and advancing patient care, found a way to miniaturize the size of the pacemaker while maintaining the most advanced pacing technology available; the investigators who rigorously evaluated the system; and the patients who ultimately will benefit from this innovation," said John Liddicoat, M.D., senior vice president, Medtronic, and president of the Cardiac Rhythm and Heart Failure Business. "The award is especially meaningful from EUROPACE-CARDIOSTIM, the preeminent scientific congress for electrophysiology in Europe."
Of the first 140 patients in the Micra TPS global clinical trial, 100 percent were successfully implanted. At one- and three-month follow ups, all patients had mean electrical pacing measurements within expected ranges. The patients were implanted by 37 physicians at 23 sites, and they spanned a wide variety of patient profiles such as age (from 21 to 94 years), weight (ranging from 41 to 148 kilograms), and residence (including Asia-Pacific, Europe and the U.S.). Patients considered to be at high risk also participated in the study, including patients with lung disease such as COPD (chronic obstructive pulmonary disease) and pulmonary hypertension.
Of the 140 patients followed for an average of 1.9 months, eight patients experienced a serious adverse event and most of these were easily managed; only two patients (1.4 percent) experienced events which resulted in prolonged hospitalization. This rate is in line with rates observed in studies of traditional pacemakers.1 Testing of electrical performance at three months showed the pacing threshold was lower (0.51V at 0.24ms) than the pre-specified performance objective (<2.0V at 0.24ms), resulting in an expected average longevity of at least 10 years.
These clinical trial results also were published in the European Heart Journal, Early performance of a miniaturized leadless cardiac pacemaker: the Micra Transcatheter Pacing Study.2
In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
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1 Udo et al. FOLLOWPACE. Heart Rhythm 2012;9:729
2 European Heart Journal, doi:10.1093/eurheartj/ehv214