On April 10, the U.S. Food and Drug Administration (FDA) approved expanded indications for Medtronic’s portfolio of cardiac resynchronization therapy with implantable cardioverter-defibrillator (CRT-D) devices, including the Concerto, Consulta, Maximo II, Concerto II, Protecta XT, and Protecta models.
These devices, previously approved for New York Heart Association (NYHA) Class III and IV heart failure (HF) only, are now approved for treatment of mildly symptomatic HF in NYHA Class II HF patients with a left ventricular ejection fraction (LVEF) of < 30%, left bundle branch block (LBBB), and a QRS duration > 130 ms. Certain NYHA Class II patients are already indicated for an implantables cardioverter defibrillator (ICD), though CRT-D offers advanced bi-ventricular pacing capabilities in addition to defibrillation protection against sudden cardiac death (SCD).
FDA announces expanded HF indications for Medtronic CRT-D devices
Rachel Klein and Chris Canary
U-Systems’s somo-v automated breast ultrasound (ABUS) system was first approved by the FDA in 2005 for commercial use as a diagnostic tool in detecting breast cancer. An improvement in reproducibility and reliability compared to hand-held ultrasound (HHUS), ABUS touts an easier technologist experience and reproducible images. However, stiff competition from other second-line modalities, such as molecular breast imaging, and uncertain incremental clinical benefit over HHUS has resulted in limited adoption—less than 100 units in the U.S. so far.
Last week, members of the Technology Insights team attended the hearing of the Radiologic Devices Panel (RDP) that recommended approval of expanding ABUS’s indications for use (IFU) to include screening as well as diagnostic care.
FDA panel recommends approval of ABUS for screening dense-breasted women
Obstetrics admissions account for nearly 20% of all inpatient stays, greatly impacting hospitals’ costs and influencing profitability. Lowering the total cost of these admissions and improving overall health for both mothers and babies is a high priority for many administrators.
Unhealthy behaviors during pregnancy can be associated with a variety of complications, including gestational diabetes, infants born at low birth weights, and hospitalization for pregnancy-related conditions. Each of these complications can add cost to the overall pregnancy episode, many of which are not able to be anticipated when the woman arrives for delivery. Having a comprehensive program to assist women with healthy lifestyle behaviors could result in cost-savings if there are fewer overall complications both during delivery and throughout early childhood.
Healthy lifestyle in pregnant women may help reduce complications, costs