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 cardiology, heart failure, electrophysiology, hypertension, structural heart disease, use of pharmaceuticals, and COVID-19.

FDA announces recall on infusion systems after software anomaly injures 2 patients
The recall has been designated as the most serious, Class I, but the issue can be remedied with a software update. The affected devices are Ivenix Large Volume Pumps manufactured by Fresenius Kabi.
Radiopharmaceutical targeted toward treatment-resistant cancer put on FDA's Fast Track
The treatment addresses cancers that express Nectin-4, a protein found in excess of 80% to 90% of urothelial cancer patients.
PFO closure after thromboembolism linked to strong 20-year outcomes
Recurrent strokes and TIAs were rare, though bleeding events among women did stand out as a trend to watch going forward.
Excessive alcohol use increases risk of amputation in CLTI patients
Identifying patients with alcohol use disorder prior to treatment may help care teams plan ahead and anticipate potential complications.
FDA shares new warning about Johnson & Johnson heart pumps after 4 injuries
This represents the latest in a series of safety concerns associated with the Impella platform. The FDA said it is still reviewing the matter and will keep the public informed as new details become available.

FDA announces recall on infusion systems after software anomaly injures 2 patients

The recall has been designated as the most serious, Class I, but the issue can be remedied with a software update. The affected devices are Ivenix Large Volume Pumps manufactured by Fresenius Kabi.

Radiopharmaceutical targeted toward treatment-resistant cancer put on FDA's Fast Track

The treatment addresses cancers that express Nectin-4, a protein found in excess of 80% to 90% of urothelial cancer patients.

A majority of medical devices involved in Class I recalls were never required by the U.S. Food and Drug Administration (FDA) to undergo premarket or postmarket clinical testing, according to new research published in Annals of Internal Medicine.[1]

PFO closure after thromboembolism linked to strong 20-year outcomes

Recurrent strokes and TIAs were rare, though bleeding events among women did stand out as a trend to watch going forward.

Excessive alcohol use increases risk of amputation in CLTI patients

Identifying patients with alcohol use disorder prior to treatment may help care teams plan ahead and anticipate potential complications.

warning safety alert recall healthcare issue

FDA shares new warning about Johnson & Johnson heart pumps after 4 injuries

This represents the latest in a series of safety concerns associated with the Impella platform. The FDA said it is still reviewing the matter and will keep the public informed as new details become available.

Women of all ages face rising risks of heart disease and stroke—but cardiologists see a path forward

Cardiovascular disease is already the No. 1 killer among women—and new projections from the American Heart Association suggest things are going to get much worse. There are certain things that clinicians and patients can do, however, to help reverse this trend and save countless lives.

Lawsuit challenges $300K hip replacement that left patient permanently impaired

A civil trial in Maine is underway, where a 71-year-old patient alleges that in 2019, her surgeon read the wrong X-ray, leading to a delayed second procedure that would have put her on the road to recovery.

Medtronic’s diabetes division seeks $7.9B valuation in upcoming IPO

MiniMed, Medtronic's diabetes business, hopes to sell 28 million shares of its common stock at a price of $25 to $28 per share.