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.   

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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. 

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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. 

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. 

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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.

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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. 

Why cardiac CT adoption remains low among primary care providers

The rapid rise of CCTA represents one of cardiology’s biggest ongoing trends, but most primary care providers are still not embracing a CT-first strategy.

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FDA sued over ‘reckless and arbitrary’ semaglutide decision

The Outsourcing Facilities Association, a Texas-based trade group, is alleging that supply issues still remain for Ozempic and Wegovy. The group believes the FDA has ignored those issues.

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Around the web

Cardiovascular Business
Cardiology employment models undergoing a dramatic shift

Gerald G. Blackwell, MD, MBA, MedAxiom's president and CEO, examined how different cardiology employment models look today compared to even a decade ago.

Cardiovascular Business
Original Banksy artwork headed to auction—proceeds will help fund heart research

The piece in question, which features a red heart-shaped balloon, has an unusual origin story, even by Banksy’s standards. 

Cardiovascular Business
Cardiology groups among the many voices asking Congress not to cut Medicaid

More than 40 U.S. healthcare organizations are urging Congress not to make sweeping Medicaid cuts that could result in approximately 7.6 million Americans losing health insurance.