Interventional Cardiology

This cardiac subspecialty uses minimally invasive, catheter-based technologies in a cath lab to diagnose and treat coronary artery disease (CAD). The main focus in on percutaneous coronary interventions (PCI) to revascularize patients with CAD that is causing blockages resulting in ischemia or myocardial infarction. PCI mainly consists of angioplasty and implanting stents. Interventional cardiology has greatly expanded in scope over recent years to include a number of transcatheter structural heart interventions.

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. 

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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. 

Teleflex to acquire Biotronik’s vascular intervention business for $791M, split into 2 separate entities

The acquisition helps Teleflex expand its interventional and vascular portfolios. Biotronik, meanwhile, is shifting its focus toward implantable devices and digital healthcare. 

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Cardiologist questions FDA’s approval process for high-risk medical devices

The technology used to diagnose, treat and manage cardiovascular disease is always evolving, keeping FDA officials quite busy. But have the agency's standards been slipping in recent years? A cardiologist with Cedars-Sinai Medical Center explored that very question.

Getinge ending production of cardiopulmonary surgical perfusion systems

The global medtech company is also looking to expand its organ transplant and ECMO portfolios.

The U.S. Food and Drug Administration (FDA) has shared a new warning about ongoing safety issues with atherectomy devices sold and distributed by Bard Peripheral Vascular, an Arizona-based subsidiary of Becton, Dickinson and Company (BD). The warning includes multiple models of Bard Peripheral Vascular’s Rotarex Atherectomy System, which is designed to target high-risk plaques and blood clots in the peripheral arteries by rotating at a high speed.

FDA warns that atherectomy devices are breaking during use—30 serious injuries, 4 deaths reported

More than 100 incidents have been reported so far. The FDA is still evaluating this issue, but the agency wanted to raise awareness as quickly as possible.

FDA announces another recall for surgical devices over safety concerns—7 new injuries reported

Maquet Cardiovascular, a subsidiary of Getinge, is recalling two of its endoscopic vessel harvesting devices due to issues with different pieces bending, peeling or detaching during use. Some of the company's other EVH devices were recently involved in a separate recall for similar reasons. 

Around the web

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

Harvard’s David A. Rosman, MD, MBA, explains how moving imaging outside of hospitals could save billions of dollars for U.S. healthcare.

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.