Medtronic Micra TPS Pacemaker Meets Initial Safety Levels - Analyst Blog
Medtronic plc’s MDT Micra Transcatheter Pacing System (TPS), which received the European CE Mark a couple of months back, recently met the initial safety and performance measures in its global clinical trial. The study results were announced at a late-breaking clinical trials session in Milan.
Medtronic’s Micra TPS is a single-chamber pacemaker intended for use in patients suffering from symptomatic bradycardia and atrial fibrillation. With a size less than one tenth of that of conventional pacemakers, Micra TPS is the smallest pacemaker to date and can be delivered directly into one’s heart, through minimally invasive procedures.
The latest released data demonstrates successful implantation of Micra TPS in all of the first 140 patients with varied profiles of age, weight and residence at 23 sites across Asia-Pacific, Europe and the U.S. High-risk patients with lung disease such as COPD (chronic obstructive pulmonary disease) and pulmonary hypertension were also considered in this set.
After 1.9 months of observation, six adverse yet manageable events were recorded. Only 1.4% (two patients) required prolonged hospitalization post-implant. This is in line with rates observed in conventional pacemaker studies.
Moreover, no infections or dislodgments were observed; neither was there any untoward event that required surgical re-operation or proved to be fatal. Further, there were zero unanticipated serious adverse device events.
According to Medtronic, this initial trial outcome is quite promising and reflects Micra TPS’ competence vis-à-vis conventional pacemakers. If the company can maintain this strong safety and performance profile with more patients over the long term, this transcatheter pacing therapy device will prove itself highly resourceful in boosting Medtronic’s revenues in this niche, worldwide.
Notably, in the U.S., Micra TPS is still under investigation and management expects to receive approval for commercial use herein in fiscal 2017. We believe the initial trial results will add momentum to this approval process.
Zacks Rank
Currently, the stock carries a Zacks Rank #3 (Hold). Some better-ranked medical products stocks include Bio-Rad Laboratories, Inc. BIO, Hospira Inc. HSP and INSYS Therapeutics, Inc. INSY. All the three stocks carry a Zacks Rank #1 (Strong Buy).
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