Siemens Healthineers gains FDA clearance for new AI-powered cardiovascular ultrasound system

Siemens Healthineers has gained U.S. Food and Drug Administration (FDA) clearance for Acuson Origin, its new cardiovascular ultrasound system featuring advanced artificial intelligence (AI) capabilities. The Acuson Origin represents a significant update from the prior Siemens Healthineers cardiovascular ultrasound system, the Acuson SC2000.

Image courtesy of Siemens Healthineers. 

The Acuson Origin system includes advanced AI algorithms designed to assist users with the treatment of diagnostic, structural heart, vascular, electrophysiological and pediatric patients. It also comes packaged with a new 4D ICE catheter capable of multiplanar reconstruction imaging with or without the use of an electrocardiogram.

Cardiologists perform world’s first valve-in-valve caval valve procedure in heart transplant patient

first-in-man valve-in-valve caval valve implantation

Fluoroscopy confirming no signs of paravalvular leak after a successful valve-in-valve caval valve implantation. Image courtesy of Jennifer von Stein, MD, et al. and JACC: Cardiovascular Interventions. 

A care team in Germany has completed what may be the first structural heart procedure of its kind on a high-risk patient. It started as a straightforward heterotopic caval valve implantation, but then paravalvular leak resulted in a change of plans. 

Cardiology still a leader in healthcare AI, trailing only radiology in FDA-cleared algorithms

An example of HeartFlow's new RoadMap Stenosis software that uses artificial intelligence (AI) to show areas of interest for possible stenting based on a patient's CT scan and FFR-CT. This software is still undergoing beta testing at several hospitals and will likely be rolled out commercially later in 2023.

An example of HeartFlow's new RoadMap Stenosis software that uses artificial intelligence (AI) to show areas of interest for possible stenting based on a patient's CT scan and FFR-CT. The software was rolled out commercially in April 2023.

At its current rate, the number of clinical AI models cleared by the FDA will break 1,000 before the end of 2024. Cardiology continues to play a significant role in this ongoing trend. 

CMS increases inpatient payment for Recor Medical, Medtronic renal denervation systems

The U.S. Food and Drug Administration (FDA) has approved Recor Medical’s Paradise Ultrasound Renal Denervation (RDN) system for uncontrolled hypertension. The Recor system gained FDA clearance in November 2023.

Paradise Ultrasound image courtesy of Recor Medical. 

Physicians using the Paradise Ultrasound Renal Denervation system from Recor Medical or Symplicity Spyral Renal Denervation system from Medtronic will soon be eligible for a much more significant reimbursement when treating Medicare patients in an inpatient setting. 

LAAO with Watchman FLX associated with positive 1-year outcomes, real-world data confirm

Left atrial appendage occlusion (LAAO) with the Watchman FLX device from Boston Scientific is associated with positive outcomes and limited adverse events after one year, according to new findings published in Circulation: Cardiovascular Interventions.[1] Many prior Watchman FLX studies, including PINNACLE FLX, had focused on the device’s performance in a controlled setting. The study’s authors hoped to gain a better understanding of its real-world impact by reviewing registry data from more than 97,000 U.S

Watchman FLX image courtesy of Boston Scientific. 

Researchers hoped to gain a better understanding of the device's real-world impact by reviewing registry data from more than 97,000 U.S. patients. Overall, the Watchman FLX was linked to positive data and limited adverse events one year after treatment. 

CMS may double Medicare payments for cardiac CT

Cardiac CT scan for a pre-procedural assessment of a left atrial appendage occlusion (LAAO) procedure at Duly Healthcare in the Chicago suburbs. Cardiac CT use has increased the past few years and now CMS is looking to double what it pays for them in the 2025 HOPPS proposed rule. Photo by Dave Fornell

Cardiac CT scan for a pre-procedural assessment of a left atrial appendage occlusion (LAAO) procedure at Duly Healthcare in the Chicago suburbs. Cardiac CT use has increased the past few years and now CMS is looking to double what it pays for them in the 2025 HOPPS proposed rule. Photo by Dave Fornell

The agency is gathering feedback on a proposal to double the amount hospitals are paid for coronary computed tomography angiography, with the comment period ending Sept. 9.

New TAVR valve for native aortic regurgitation linked to positive 30-day outcomes

The J-Valve manufactured by JC Medical, a Genesis MedTech company, includes a self-expanding nitinol frame, bovine pericardial leaflets and three anchor rings designed to assist operators with alignment. Its delivery system was built with transfemoral access in mind, and JC Medical plans to offer the valve in five different sizes.

Structural heart specialists from The Christ Hospital. This team participated in a new EFS study focused on the J Valve from JC Medical. Image courtesy of JC Medical, a Genesis MedTech company, and The Christ Hospital.

The J Valve from JC Medical was linked to positive outcomes and “excellent” hemodynamic data after 30 days in an early feasibility study published in JACC: Cardiovascular Interventions. Researchers noted that the valve showed potential in patients with large aortic annuli, which represents an "unmet critical need" at this stage.