Dive brief:
- Medtronic shared new data showing that its extravascular implantable cardioverter defibrillator (EV ICD) met safety and efficacy criteria, with a defibrillation success rate of 98.7%.
- The device is designed to treat rapid heart rhythms that can lead to sudden cardiac arrest. The wire is placed under the sternum, which Medtronic says helps prevent complications that can come with heart and vein shunts, such as infection or vessel occlusion.
- The data could position Medtronic’s device as a competitor to Boston Scientific’s subcutaneous implantable defibrillator (S-ICD) system, which won Food and Drug Administration approval in 2012, JP Morgan analysts wrote in a Sunday research note. Medtronic is awaiting CE marking and hopes to get FDA approval next year, CEO Geoff Martha said on the company’s most recent earnings call.
Diving knowledge:
Medtronic presented the results of the study at the Congress of the European Society of Cardiology in Barcelona on Friday. Of the 306 patients, 98.7% had satisfactory defibrillation at the time the device was implanted. After six months, 92.6 percent were free of major system- or procedure-related complications, according to data published in the New England Journal of Medicine.
A total of 25 major complications were observed in 23 patients, and a total of 29 patients had received 118 inappropriate shocks for 81 arrhythmic episodes.
During the mean follow-up period of 10.6 months, eight systems were removed without a replacement device.
Analysts at JP Morgan wrote that, “overall, the results are positive for Medtronic, they appear to be competitive relative to Boston’s S-ICD and should help modestly expand the market…”
Still, they wrote that they expect Boston Scientific to continue to be the market leader in non-transvenous defibrillators, given that it has a strong lead and a long history in the market.
When comparing data from the two devices, Medtronic’s EV ICD overall appears to be competitive relative to Boston’s S-ICD, the analysts wrote. despite caveats with trial comparisons, particularly because Medtronic’s was a single-arm trial.
Analysts noted the highest rate of inappropriate shock at 10.6 months in the Medtronic study, at 9.7 percent, compared with 2.4 percent at one year for Boston Scientific’s Emblem MRI S-ICD in his studio UNTOUCHED. Still, they said most of the incidents occurred before the study, and many shocks were prevented by using an antitachycardia pacemaker.