CMS has been paying cardiologists for prolonged non-face-to-face time since last year, but many seem unaware. (Cardiovascular Business)
Advanced imaging of the penis in men with prostate cancer provided the missing link to prove that atherosclerosis can cause erectile dysfunction. (Journal of the American College of Cardiology)
In another bad week for sartans, Aurobindo Pharma/Acetris Health’s valsartan and valsartan/amlodipine recall was expanded and one lot of Macleods Pharmaceuticals’ losartan/hydrochlorothiazide was recalled due to contamination with the probable carcinogen NDEA. That’s in addition to a recall spurred by a now third nitrosamine contaminant (NMBA).
LifePak 15 defibrillators are under a Class I recall due to risk that the devices may lockup after delivering a shock, which has already killed and injured patients.
Novel oral lipid lowering agent bempedoic acid and its combination with ezetimibe (Zetia) have been submitted for FDA approval ahead of presentation of the CLEAR Wisdom pivotal trial results at the American College of Cardiology (ACC) meeting later this month, Esperion announced.
Among studies released online in the Journal of the American College of Cardiology and JACC: Cardiovascular Interventions ahead of presentation at the ACC meeting in New Orleans, findings included:
“Transition to a closed unit model staffed by a heart failure specialist is associated with a reduction in overall CICU mortality,” found another study being presented at the ACC.
Obesity in childhood and adolescence was added to the list of conditions raising the risk of premature heart disease in a scientific statement from the American Heart Association. (Circulation)
The Selution sirolimus-eluting balloon catheter for diseased coronaries got breakthrough designation from the FDA. (Cardiovascular News)
A novel antisense drug against apolipoprotein C-III, volanesorsen (Waylivra), was recommended for conditional approval in Europe to treat the rare lipid disorder familial chylomicronemia syndrome.
The Navitian coronary microcatheter was cleared for use in chronic total occlusions in Europe. (FDANews)
Advisors to the European Medicines Agency also recommended approval of andexanet alfa (Ondexxya) as a reversal agent for rivaroxaban (Xarelto) and apixaban (Eliquis).
The R-One interventional cardiology-focused robotic system also gained market access in Europe. (Mass Device)
Medicare patients with cancer also have higher coronary artery disease expenditures, especially those with colorectal cancer, researchers reported in the Journal of the National Comprehensive Cancer Network.