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.

Philips pulls endovascular devices from market after safety issues prompt Class I recall

Philips is recalling all sizes of its Tack Endovascular System after 20 patient injuries were reported. Interventional cardiologists are urged to stop using the device immediately.

Boston Scientific enters renal denervation market with acquisition worth up to $540M

Boston Scientific has announced another significant M&A deal, scooping up an Israeli medtech company focused on RDN technology.

FCI scanner more ably detects cancer spread than traditional MRI

New low-field scanner detects cancer spread better than traditional breast MRI

Researchers involved in its development are hopeful that the scanner could eventually lead to improved outcomes in cancer patients who require surgery to remove malignant tissue.

Cardiologists recommend complete revascularization, intravascular imaging in new ACS guidelines

The American College of Cardiology and American Heart Association published the new guidelines with assistance from other leading U.S. medical societies.

FDA issues Class I recall on newborn resuscitation devices

The recall impacts products from ROi, supplied by Mercury Medical. A defective spring can cause a controller to malfunction, resulting in poor ventilation.

FDA announces recall of endoscope sheaths after 26 injuries

While there have been no reported deaths, certain lots of Olympus single-use guide sheath kits are to be quarantined immediately.

The late-breaking U.S. multicenter admIRE clinical trial at the Heart Rhythm Society 2024 meeting, showed positive data on the long-term safety and effectiveness of the the Biosense Webster Varipulse pulsed field ablation (PFA) system in patients with paroxysmal atrial fibrillation. #HRS #HRS2024 #PFA

FDA announces catheter recall for Johnson & Johnson PFA system due to stroke risk

The recall comes after approximately 3% of patients treated with the device during the early stages of its U.S. rollout experienced a stroke or transient ischemic attack following surgery. The expected stroke rate is closer to 1%, the FDA explained.

Request for an American Board of Cardiovascular Medicine denied—cardiology groups ‘deeply disappointed’

The ACC, AHA, HFSA, HRS and SCAI all worked together to try and make the new board a reality. Though their proposal has been denied, the groups say they are not done fighting.

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