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.

Medtronic recalls data management software, urging healthcare providers to run update
The error caused incorrect glucose data to be displayed to clinicians. According to Medtronic, any treatment decisions or recommendations based on those data need to be revisited.
Catheters recalled due to defect—FDA highlights risk of stroke or brain damage
The recall was put in place after a hydrophilic coating was discovered on the inside of the devices. According to the FDA, patients treated with the catheters could face a number of significant risks.
Abbott shares safety concerns with millions of CGM sensors—7 deaths reported
Approximately 3 million FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors need to be replaced due to a risk of incorrect glucose readings. Abbott has received reports of 736 severe adverse events and seven deaths that may be related to this issue.
Cardiology groups share new recommendations for performing safe, effective cardiac ablations in ASCs
The timing of this new guidance from the Heart Rhythm Society and American College of Cardiology could not have been better—the document went live just as CMS finalized its decision to cover cardiac ablation procedures performed in ASCs.
Adjustable interatrial shunt for heart failure shows promise in first-in-human trial
Gregg Stone, MD, spoke to Cardiovascular Business about early data from the ATHENS-HF trial. Ten heart failure patients were treated with the adjustable device, and each implant was a success.

‘A significant step forward’: Advocates cheer as heart health bill passes Senate

The HEARTS Act is focused on improving cardiomyopathy education and awareness while getting more AEDs in schools. The ACC, AHA and other medical societies have supported the bipartisan bill, which now heads to the president's desk to be signed into law.

FDA approves J&J MedTech’s Impella heart pumps to treat pediatric patients

Johnson & Johnson MedTech partnered with the Advanced Cardiac Therapies Improving Outcomes Network to confirm these devices could safely and effectively treat younger patients.

Industry concerns over paclitaxel-coated devices may have put PAD patients at risk

Back in 2019, the FDA issued a warning about the use of paclitaxel-coated devices when treating peripheral artery disease. The agency took back that warning in 2023, but it appears to have made a significant impact on patient care.

Back in October 2024, heart surgeons with the WVU Heart and Vascular Institute in Morgantown, West Virginia, performed the world’s first robotic aortic valve replacement and coronary artery bypass (RAVCAB) procedure. Now, the team behind that historic surgery has shared its full story for the first time, publishing an in-depth look at the procedure in The Annals of Thoracic Surgery, an official journal from the Society of Thoracic Surgeons.[1]

Heart surgeons detail world’s first robotic heart procedure of its kind

The care team behind the very first robotic aortic valve replacement and coronary artery bypass surgery has written about the experience in The Annals of Thoracic Surgery. The group discussed the development of the technique, how the patient was chosen for treatment and other key details.

How opioid use disorder affects brain size and function

The CDC estimates that over 6 million people in the U.S. struggle with OUD, and prior research has indicated that only 20% receive treatment for the disorder.

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Cardiothoracic surgery linked to a lack of diversity, uneven salaries: What can be done?

A brand new analysis explored diversity, equity and inclusion within the specialty of cardiovascular surgery. It also included several recommendations for leaders looking to help create change and improve patient care.

Years of progress have made TAVR more effective when treating concomitant mitral stenosis

Newer balloon-expandable TAVR valves are associated with much better outcomes for patients presenting with both severe AS and severe MS than older models.

Artivion, an Atlanta-based medical device company, has received a Humanitarian Device Exemption (HDE) from the U.S. Food and Drug Administration (FDA) for its AMDS Hybrid Prosthesis designed to treat DeBakey Type 1 dissections when malperfusion occurs. This HDE ensures select patients can be treated with the device before the FDA makes its final approval decision.

First surgical device of its kind granted key FDA exemption

This update helps ensure Artivion's AMDS Hybrid Prosthesis can be used to treat high-risk patients as the FDA makes its final approval decision. The news came as Artivion works to bounce back from a cybersecurity attack that occurred in November.

Clinical

Medtronic recalls data management software, urging healthcare providers to run update

Catheters recalled due to defect—FDA highlights risk of stroke or brain damage

Abbott shares safety concerns with millions of CGM sensors—7 deaths reported

Cardiology groups share new recommendations for performing safe, effective cardiac ablations in ASCs

Adjustable interatrial shunt for heart failure shows promise in first-in-human trial