Clinical

This channel newsfeed includes clinical content on treating patients or the clinical implications in a variety of cardiac subspecialties and disease states. The channel includes news on cardiac surgery, interventional cardiologyheart failure, electrophysiologyhypertension, structural heart disease, use of pharmaceuticals, and COVID-19.   

Longer reach guide catheter nets 510(k) status

The FDA has given 510(k) clearance to Aptus Endosystems for its 28mm Tip Reach Heli-FX Guide, a longer reach guide catheter used in the treatment of wide neck abdominal aortic aneurysms.

Dual therapy stent approved in Europe

A dual therapy stent that accelerates endothelial coverage and controls neo-intimal proliferation received CE mark in Europe for the treatment of coronary artery disease.

FDA paves way for stent graft system, sheath

The FDA approved Medtronic’s Endurant II Aorto-Uni-Iliac (AUI) Stent Graft System and gave 510(k) clearance for the Sentrant Introducer Sheath.

POZEN announces FDA acceptance of filing of New Drug Application for PA32540/PA8140 tablets

POZEN Inc. (NASDAQ: POZN), a pharmaceutical company committed to transforming medicine that transforms lives, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review, the New Drug Application (NDA) for PA32540/PA8140.

AstraZeneca offers $443M to bolster drug pipeline

AstraZeneca will pay up to $443 million to acquire Omthera Pharmaceuticals, a drug company that specializes in treatments for patients with elevated triglyceride levels.

Xarelto approved in Europe for post-ACS treatment

The European Commission approved the oral anticoagulant rivaroxaban for the prevention of atherothrombotic events after an acute coronary syndrome (ACS) in adult patients with elevated cardiac biomarkers.

Evidence tilts toward diabetes risk with potent statins

Older patients treated with a high potency statin faced a 10 percent to 22 percent increased risk of new onset diabetes, according to results published online May 23 in BMJ. The authors of an accompanying editorial emphasized that the overall benefits outweigh the risks, “provided the treatment is targeted properly.”

FDA makes Zilver stent Class I recall

The FDA has issued a Class I recall of Zilver PTX Drug-Eluting Peripheral Stent.

Around the web

Several key trends were evident at the Radiological Society of North America 2024 meeting, including new CT and MR technology and evolving adoption of artificial intelligence.

Ron Blankstein, MD, professor of radiology, Harvard Medical School, explains the use of artificial intelligence to detect heart disease in non-cardiac CT exams.