Biotronik's ultrathin Orsiro stent demonstrated superiority over Xience with respect to target lesion failure (TLF) at 12 months, according to newly released data from the BIOSTEMI trial.1 At the European Society of Cardiology (ESC) 2019 Congress, Aug. 31-Sept. 4 in Paris, France, Juan Fernando Iglesias, M.D., Ph.D., Geneva University Hospitals, Geneva, Switzerland, unveiled the results of the randomized controlled trial (RCT) in a late-breaking session. The results have also been published in The Lancet.

Abbott announced the launch of the company's TRILUMINATE Pivotal trial evaluating the safety and effectiveness of its TriClip transcatheter tricuspid valve repair system for the treatment of severe tricuspid regurgitation (TR). This is the first pivotal Investigational Device Exemption (IDE) trial in the U.S. to evaluate a catheter-based, non-surgical treatment for patients with severe TR – a condition in which the valve does not close properly, allowing blood to flow backward into the heart, which forces the heart to work harder. In severe cases, this condition can potentially lead to heart failure if left untreated.

September 4, 2019 – Novartis announced results from two new clinical trials evaluating improvement in heart structure and function and long-term safety of Entresto (sacubitril/valsartan) in patients with heart failure with reduced ejection fraction (HFrEF).

Shockwave Medical Inc. has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its Shockwave intravascular lithotripsy (IVL) system with the Shockwave C2 Coronary IVL Catheter. The device is currently the subject of an Investigational Device Exemption (IDE) study called DISRUPT CAD III. The Shockwave C2 IVL Catheter is a proprietary tool designed to fracture problematic calcium using sonic pressure waves in order to facilitate stent delivery, deployment and optimal expansion, thereby improving blood flow to the heart muscle.