Study: Abbott ’ s CardioMEMS monitor performs better in real world than pivotal trial

Real-world results from patients with Abbott‘s (NYSE:ABT) CardioMEMS implantable heart monitor, which it acquired along with St Jude Medical in Jan., show greater reduction in pulmonary artery pressure than seen in the pivotal Champion clinical trial of the device, according to a new study. The study examined the 1st 2,000 patients implanted with the CardioMEMS device in general practice use, with results published in the Feb. 21 issue of the journal Circulation. Researchers in the study analyzed de-identified data from St. Jude’s Merlin.net database to examine PA pressure trends of the 1st consecutive 2,000 patients with at least 6 months of follow ups. Patient data indicated that at implant, PA pressure for general use patients was at 34.9±10.2 mmHg, higher than the average 31.3±10.9mmHg for those treated with CardioMEMS in the Champion trial. General-use patients reported an AUC of -32.8mmHg days at 1 month, -156.2mmHg days at 3 months and -434mmHg days at 6 months, significantly lower than patients treated with the device in the pivotal Champion trial. The median time between patient transmission was 1.27 days, according to the study. “The first 2,000 general-use patients managed with hemodynamic guided HF care had higher PA pressures at baseline and experienced greater reduction in PA pressure over time compared to the pivotal Champion clinical trial. These data demonstrate that general-use of implantable hemodynamic technology in a non-trial setting le...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Cardiovascular Clinical Trials Patient Monitoring Abbott St. Jude Medical Source Type: news