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.

Edwards Lifesciences gains CE mark approval for Evoque transcatheter tricuspid valve replacement (TTVR) system

Old age, RBBB help predict when TTVR patients may require a permanent pacemaker

Though just a small, single-facility study, these findings help care teams know what to look for when performing transcatheter tricuspid valve replacement.

Medtronic has received U.S. Food and Drug Administration (FDA) approval for its Evolut FX+ transcatheter aortic valve replacement (TAVR) system for the treatment of symptomatic severe aortic stenosis.

Medtronic receives updated FDA approval for redo TAVR

The company also launched a new clinical trial designed to follow redo TAVR patients who present with symptomatic bioprosthetic valve failure for up to five years.

San Francisco TCT 2025

CRF unveils late-breaking clinical trials for TCT 2025 in San Francisco

This year marks the 37th annual gathering of the popular Transcatheter Cardiovascular Therapeutics conference. What started as a small gathering in 1988 has grown into one of interventional cardiology’s biggest events.

Johnson & Johnson MedTech Automated Impella Controller

FDA details new risk with Johnson & Johnson heart pump controllers after patient’s death

This latest alert was put in place after Johnson & Johnson MedTech learned that some of its Automated Impella Controllers were built to the wrong specifications, impacting their ability to function. Affected devices should not be used going forward.

The Abbott Esprit BTK everolimus-eluting biosorbable scaffold system for below the knee peripheral artery disease on display at TCT 2024. Photo by Dave FornellTCTn 2024 DF

Abbott’s dissolving stent picks up a key approval

It's another big victory for Abbott's bioresorbable stent for BTK PAD. 

FDA announces new recall of self-expanding stents due to risk of ‘serious harm’

The Class I recall includes more than 26,000 vascular stents from Boston Scientific. These devices have been linked to a risk of potential resistance when the stent delivery system is being withdrawn. 

Boston Scientific said it initiated the AGENT DCB STANCE trial to assess the safety and effectiveness of the Agent Drug-Coated Balloon (DCB) compared to the standard of care using either percutaneous coronary intervention (PCI) with drug-eluting stents (DES) and/or balloon angioplasty. The trial will enroll more than 1,600 patients and is expected to a primary completion date in 2028.

Boston Scientific launches study comparing drug-coated balloons to standard care

"This important study will evaluate the potential benefits of the AGENT DCB for patients with certain anatomical features in de novo coronary lesions, where the avoidance of stents is preferable to help circumvent potential complications,” said Janar Sathananthan, MD, chief medical officer, interventional cardiology therapies, Boston Scientific. 

The U.S. Food and Drug Administration (FDA) updated the Breakthrough Device Program designations data this week, which now includes 1,176 Breakthrough Device designations, of which 160 have gained market clearance. Cardiovascular devices lead these with 243 devices, the highest number out of all other clinical categories. This includes 16 new cardiovascular devices cleared in the past year.

Cardiovascular device approvals continue to lead the FDA's Breakthrough Device Program

Cardiology is number one in FDA Breakthrough Device designations at 218, the highest number out of all other clinical categories. This includes 16 new devices cleared in the past year.