Michael Barbella, Managing Editor04.13.24
A double dose of (clinical) data from top company veteran Medtronic plc packed a dominant digital punch this past week.
The medtech behemoth drove significant MPO website traffic by sharing data on two of its cardiac devices. Results from a comparative trial of transfemoral transcatheter aortic valve replacement (TAVR) technology showed noninferior clinical outcomes and superior valve performance for the Evolut TAVR platform compared to Edwards Lifesciences’ Sapien platform. Evolut TAVR met non-inferiority for the clinical outcome primary endpoint, a composite of all-cause mortality, disabling stroke, or heart failure rehospitalization at one year (9.4% Evolut vs. 10.6% Sapien, p<0.001 for non-inferiority). It also demonstrated superiority for the valve function primary endpoint, bioprosthetic valve dysfunction through one year (9.4% Evolut vs. 41.6% Sapien, p<0.001 for superiority).
Medtronic touted similar positive results for the Sphere-360, its investigational, single-shot mapping and ablation catheter using pulsed field (PF) energy to treat paroxysmal atrial fibrillation. Study data from 85 patients in three European centers showed 81.8% freedom from atrial arrhythmias after one year of follow up, and 100% freedom in the sub-group treated with the optimized and most recent pulse configuration.
Despite the double data delights, however, Medtronic still took a back seat in pageviews to Mack Molding, which announced the realignment of its Northern Division sales and engineering team, and Philips' ongoing Respironics recall nightmare. The U.S. Justice Department on April 9 filed a consent decree of permanent injunction against Philips over its ongoing recall of sleep apnea and respiratory devices. The settlement restricts Philips from producing or selling new continuous positive airway pressure (CPAP) and bi-level positive airway pressure (BiPAP) machines and other devices in the United States until the company meets certain requirements. Philips also faces restrictions on exporting devices that are being provided to patients impacted by the recall “to help ensure remediation of U.S. patients is prioritized over export for commercial distribution.”
The medtech behemoth drove significant MPO website traffic by sharing data on two of its cardiac devices. Results from a comparative trial of transfemoral transcatheter aortic valve replacement (TAVR) technology showed noninferior clinical outcomes and superior valve performance for the Evolut TAVR platform compared to Edwards Lifesciences’ Sapien platform. Evolut TAVR met non-inferiority for the clinical outcome primary endpoint, a composite of all-cause mortality, disabling stroke, or heart failure rehospitalization at one year (9.4% Evolut vs. 10.6% Sapien, p<0.001 for non-inferiority). It also demonstrated superiority for the valve function primary endpoint, bioprosthetic valve dysfunction through one year (9.4% Evolut vs. 41.6% Sapien, p<0.001 for superiority).
Medtronic touted similar positive results for the Sphere-360, its investigational, single-shot mapping and ablation catheter using pulsed field (PF) energy to treat paroxysmal atrial fibrillation. Study data from 85 patients in three European centers showed 81.8% freedom from atrial arrhythmias after one year of follow up, and 100% freedom in the sub-group treated with the optimized and most recent pulse configuration.
Despite the double data delights, however, Medtronic still took a back seat in pageviews to Mack Molding, which announced the realignment of its Northern Division sales and engineering team, and Philips' ongoing Respironics recall nightmare. The U.S. Justice Department on April 9 filed a consent decree of permanent injunction against Philips over its ongoing recall of sleep apnea and respiratory devices. The settlement restricts Philips from producing or selling new continuous positive airway pressure (CPAP) and bi-level positive airway pressure (BiPAP) machines and other devices in the United States until the company meets certain requirements. Philips also faces restrictions on exporting devices that are being provided to patients impacted by the recall “to help ensure remediation of U.S. patients is prioritized over export for commercial distribution.”