Recent FDA updates: Device recalls, expanded indications for HF therapies and more

Healio and Cardiology Today have aggregated the latest news from the FDA.

Recent updates include the Class I recall of catheters for vascular procedures; proposed new indications for sacubitril/valsartan (Entresto, Novartis) and spironolactone; and more.

FDA designates recalls of two vascular catheters as Class I

The FDA has classified Cook Medical’s recall of two catheters used in vascular procedures as Class I, the most serious type. Read more

FDA approves updated labeling for LVAD for use in pediatric HF

Abbott announced the FDA approved updated labeling for its implantable heart pump for use in pediatric patients with advanced refractory left ventricular HF. Read more

FDA advisory panel endorses spironolactone for HF hospitalization reduction in HFpEF

The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 8 to 4 with one abstention in favor of an indication of spironolactone for the reduction of HF hospitalization in certain patients with HF with preserved ejection fraction. Read more

Clot removal devices for patients with stroke urgently recalled

The FDA announced that in response to its request, Penumbra has issued an urgent recall of reperfusion catheters for clot removal in patients with stroke due to risk for unexpected death or serious injury. Read more

FDA panel supports expanded indication for sacubitril/valsartan in some with HFpEF

The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 12-1 that an expanded indication is warranted for sacubitril/valsartan, which could allow it as a treatment for certain patients with HF with preserved ejection fraction. Read more

FDA reiterates importance of yearly, lifelong follow-up for Endologix AAA grafts

The FDA issued a safety communication to remind patients and health care providers of the importance of at least yearly, lifelong follow-up for patients with Endologix AFX endovascular grafts to monitor for type III endoleaks. Read more

FDA approves AI algorithm suite for personal ECG device

AliveCor announced its next-generation AI algorithms for ECG interpretation have received 510(k) clearance from the FDA. Read more

Aspiration system for PE receives expanded indication

Penumbra announced its aspiration system to treat pulmonary embolism has received clearance for an expanded indication from the FDA. Read more

Self-expanding venous stent receives FDA approval

Cook Medical announced its self-expanding venous stent received FDA premarket approval. Read more