Care Delivery

This channel includes news on cardiovascular care delivery, including how patients are diagnosed and treated, cardiac care guidelines, policies or legislation impacting patient care, device recalls that may impact patient care, and cardiology practice management.

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The U.S. Food and Drug Administration (FDA) has announced that Inari Medical is recalling its ClotTriever XL catheter for removing blood clots and other blockages from large blood vessels. The news comes after the FDA received several reports of “serious adverse events” due to the device becoming entrapped or blocking arteries in the patient’s lungs. Six deaths and four other patient injuries have been associated with the issue so far.

FDA announces recall of Inari Medical catheter after 6 deaths, 4 injuries

The FDA ruled that this is a Class I recall due to the significant risks for patients. Customers are not required to return the devices, however. Inari Medical has provided updated warnings and recommendations that should be followed. 

cardiologist viewing heart data

TAVR and SAVR linked to comparable long-term outcomes, new meta-analysis confirms

Researchers combined data from three well-known clinical trials—NOTION, Evolut Low Risk and PARTNER 3—and evaluated thousands of low-risk patients who presented with severe aortic stenosis. 

The U.S. Food and Drug Administration (FDA) has announced that Defibtech, a Nihon Kohden company, is recalling its RMU-2000 ARM XR Chest Compression Device due to significant safety concerns. This is a Class I recall, which means the FDA believes using the device “may cause serious injury or death.”

Automated chest compression device recalled after patient death

Regulators emphasized that these devices should not be used due to significant safety risks. 

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Industry Watcher’s Digest

The NIH’s Office of Science Policy recently posted some essential new guidance for healthcare researchers. 

artificial intelligence AI in healthcare kaiser permanente daniel yang md

7 points of positivity likely to win buy-in for healthcare AI

Kaiser Permanente AI exec Daniel Yang, MD: ‘With a focus on building trust, we use AI only when it advances our core mission of delivering high-quality, affordable healthcare services.’

heart surgery surgeons

High vs. low oxygen levels during heart surgery: Is one strategy safer than the other?

Researchers tracked patients undergoing elective cardiac surgery at a high-volume medical center, treating 50% of the selected cohort with above-average oxygen levels.

Interventional cardiologists in Canada have performed the world’s first implant of a new coronary sinus reducer designed to treat chest pain patients who see no benefits from other available interventional or surgical treatments. The A-Flux Reducer System was designed and developed by VahatiCor, a new medical device company associated with California-based T45 Labs.

Cardiologists detail world’s first implant of new device for ‘no-option’ chest pain patients

The A-Flux Reducer System by VahatiCor was designed to “conform seamlessly” to any patient’s anatomy, and it can be repositioned or retrieved as necessary.

ai in healthcare artificial intelligence digital transformation

Industry Watcher’s Digest

When a hacker breaches a business, the usual break-and-entry point is a hole opened by a phishing scam. 

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