Intravascular lithotripsy (IVL) Shockwave Medical PCI PAD CAD Disrupt PAD Disrupt CAD SCAI 2022

Is IVL equally effective in male and female patients? Shockwave Medical aims to find out with a historic new study

Shockwave announced at TCT 2022 that it hopes to enroll up to 400 patients for a new all-female clinical trial.

The Pulnovo pulmonary artery denervation catheter. In February 2021, the devices was granted the U.S. Food and Drug Administration (FDA) breakthrough device designation. #TCT2022 #PAH

Pulmonary artery denervation shows promise to treat pulmonary arterial hypertension

Pulmonary artery denervation may offer a new therapy option for this difficult-to-treat population.

The Pascal transcatheter mitral valve repair system. Similar to the latest version of the MitraClip, the Pascal can operate each leaflet independently to grasp the mitral valve leaflets. Results of the CLASP IID trial at #TCT2022.

Pascal transcatheter mitral repair device performs as well as MitraClip in late-breaking CLASP IID Trial 

Comparison between transcatheter edge-to-edge repair (TEER) devices found Pascal was non-inferior compared with MitraClip in the CLASP IID pivotal trial.

Use of ultrasound to guide needles used for femoral vascular access for cath lab procedures can help reduce bleeding and vascular complications. But the Universal Trial at TCT 2022 showed no difference. Image courtesy of Sonosite

Ultrasound guidance for femoral access did not reduce bleeding or vascular complications in TCT late-breaker

The UNIVERSAL Trial, one of the largest multicenter randomized trials comparing ultrasound with fluoroscopic guidance vs. fluoroscopic guidance alone, found there was no reduction in major vascular access complications. 

Sentinel Boston Scientific PROTECTED TAVR stroke disabling stroke

TAVR embolic protection devices fail to reduce stroke risk, but some cardiologists—and a leading vendor—remain encouraged

The PROTECTED TAVR results presented at TCT 2022 resulted in a mix of reactions. For some cardiologists, the slight reduction in the risk of a disabling stroke after TAVR is a positive result. For others, it was simply not enough. 

TCT 2022 Robert Califf FDA Commissioner

FDA Commissioner Robert Califf delivers fiery speech on innovation, healthcare disparities and misinformation at TCT 2022

“The United States is essentially inventing the technology and then the rest of the world is figuring out how to use it better,” he said.

he U.S. Food and Drug Administration (FDA) granted market clearance ion September 2022 for the Edwards Lifesciences Corp. Pascal Precision transcatheter valve repair system for transcatheter edge-to-edge repair (TEER). It is indicated for the treatment of patients with degenerative mitral regurgitation (DMR).

FDA clears Edwards Pascal device for transcatheter mitral valve repair

This is the second FDA-cleared transcatheter repair device for the mitral valve. Data from pivotal trial comparing Pascal vs. MitraClip will be presented at TCT 2022.

Examples of structural heart transcatheter valve replacement procedure planning CT scans and post procedure followup for TMVR and TAVR.

VIDEO: CT imaging for TAVR and TMVR structural heart interventions

Joao Cavalcante, MD, director, cardiac MRI and structural CT labs, Minneapolis Heart Institute, discusses the use of cardiac CT imaging to plan and guide structural heart procedures.