When it came to the transcatheter aortic valve replacement (TAVR) market, the U.S. was at least five years behind Europe and other parts of the world. But in recent years the FDA has become much more collaborative and open to getting involved in early feasibility studies, as evidenced by the first U.S. patient to undergo a transcatheter mitral valve replacement (TMVR) procedure in the U.S., as part of a multicenter global feasibility study.

A study evaluating an implant-based approach to treating osteoporotic vertebral compression fractures (VCFs) compared to the standard of care, balloon kyphoplasty (BKP), met its primary endpoint of non-inferiority early, despite differences in risk factors favoring the BKP group. Benvenue Medical (Santa Clara, California) said the results of the KAST trial, published in the online journal Spine, allows the study to conclude before full enrollment.

Newer percutaneous ventricular assist devices (pVADs) have the potential to increase the amount of circulatory support for patients undergoing percutaneous coronary intervention (PCI), but they are more expensive and are associated with increased risks compared to intraaortic balloon pumps (IABPs), according to a recent study that compared the clinical and economic impact of pVADs with IABPs for high-risk PCI patients.