In a 21-patient first in-human pilot trial, Medtronic’s Extravascular Implantable Cardioverter Defibrillator (EV ICD) system successfully terminated induced ventricular arrhythmias in 89.5% of patients and achieved pacing capture in 95% of patients.
[Editor's note:Complete historical information on important medical device trial announcements is available from Informa’s Meddevicetracker. For an archive of previous Medtech Insight articles on medtech clinical trials, visit the Clinical Trials page.]
Medtronic PLC is encouraged by the first in-human experience with its substernal Extravascular Implantable Cardioverter Defibrillator (EV ICD).
A recent approval from the US FDA allowing Boston Scientific to broaden its labeling for its pulse field ablation system means more patients with one type of AFib will have access to a promising new treatment.
Broad participation by EU member states in a new pilot to test a unified procedure for evaluating applications for combined drug and IVD studies shows they recognize its value, says Monique Al, vice-chair of the Clinical Trials Coordination Group.
Dexcom’s CEO Kevin Sayer discusses this fall’s planned launch of the 15-day G7 CGM, downplays Abbott’s dual-sensor while focusing on development of multi-analyte G8, making OTC Stelo app more “consumerish” for Europeans, and more.
As the EU tests the feasibility of a radical “all-in-one” procedure for combined drug and IVD studies, sponsors are being urged to approach this novel framework with flexibility and openness.
