The Society of Thoracic Surgeons (STS) and the American College of Cardiology (ACC) have received an investigational device exemption (IDE) from the FDA to study alternative access approaches for transcatheter aortic valve replacement (TAVR) using the STS/ACC TVT Registry.

Diclofenac, one of the most cardiotoxic nonsteroidal anti-inflammatory drugs (NSAIDs), is also the most widely used, according to an analysis of usage patterns and relative risks. The results call into question whether information about relative risk is filtering down into clinical practice.

Ticagrelor's benefits appear to carry over time, according to an analysis that found ticagrelor treatment resulted in not only fewer primary outcome events (MI, cardiovascular death, stroke) but also fewer subsequent events compared with clopidogrel. But an accompanying editorial questioned the use of composite endpoints to track subsequent events, and suggested a protocol to define and report recurrent endpoints more specifically.

The FDA has notified healthcare professionals of a Class I recall of St. Jude Medical’s Amplatzer TorqVue FX delivery system because, in a small number of cases, the distal end of the core wire potentially could fracture when exposed to a combination of certain cardiac anatomies and usage conditions.

Bayer HealthCare has submitted the oral investigational drug riociguat to treat patients with inoperable chronic thromboembolic pulmonary hypertension and pulmonary arterial hypertension for regulatory approval in the U.S. and in the European Union (EU).

The FDA is requesting additional cardiovascular data from a dedicated cardiovascular outcomes trial from Novo Nordisk for insulin degludec (Tresiba) and insulin degludec/insulin aspart (Ryzodeg). Results must be available for review before the FDA will complete the new drug applications.

Merck successfully fended off the generics company Mylan in a court battle over its cholesterol-lowering drugs ezetimibe (Zetia) and ezetimibe/simvastatin (Vytorin).

Edwards Lifesciences, a developer of heart valves and hemodynamic monitoring, has reported increased net income for the 2012 fiscal year and the 2012 fourth quarter, both of which ended Dec. 31, 2012.