CRT 2024: Evolut TAVR is a safe, effective, and economically cost-effective treatment option for low-risk severe aortic stenosis patients compared to surgery up to four years DUBLIN, March 11, 2024 — Medtronic plc, a global leader in healthcare technology, today announced two late-breaking data presentations on four-year outcomes from […]
Author: Ken Dropiewski
Large, Real-world Studies Demonstrate Continued Excellent Outcomes for Patients Receiving Edwards SAPIEN TAVR
WASHINGTON–(BUSINESS WIRE)–Edwards Lifesciences (NYSE: EW) announced today at Cardiovascular Research Technologies (CRT) 2024 the compelling results from two large, real-world studies based on TVT Registry data that demonstrated continued excellent outcomes for patients treated with the Edwards SAPIEN valve platform. A study of Edwards’ latest TAVR technology, the SAPIEN 3 Ultra RESILIA valve, found lower rates of paravalvular leak (PVL) at 30 days, lower echo-derived gradients and larger eff
Saranas Reveals Groundbreaking SAFE-MCS Study Results at CRT 2024
HOUSTON–(BUSINESS WIRE)–Saranas, Inc. announced today the compelling results of SAFE-MCS, a multi-center clinical study evaluating the safety of complex high-risk percutaneous coronary intervention (PCI) using mechanical circulatory support (MCS) and surveillance with the Early Bird® Bleed Monitoring System (EBBMS). Dr. Babar Basir, Director of Acute Mechanical Circulatory Support, at Henry Ford Health System and co-principal investigator of SAFE-MCS, presented “The Safe Surveillance of Percu
PulseCath Achieves MDR CE Certification for iVAC 2L, Paving the Way for Complex High-Risk Percutaneous Coronary Interventions
ARNHEM, Netherlands, March 11, 2024 /PRNewswire/ — PulseCath B.V., a leader in the expanding field of percutaneous ventricular assist devices for high-risk PCI, proudly announces the successful achievement of the transition from Medical Device Directive (MDD) CE marking to Medical Device…
United States Food & Drug Administration (FDA) Supports Accelerated Approval Pathway for Rexlemestrocel-L in End-Stage Heart Failure Patients with a Left Ventricular Assist Device (LVAD)
NEW YORK, March 10, 2024 (GLOBE NEWSWIRE) — Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that U.S. FDA supports an accelerated approval pathway for rexlemestrocel-L, Mesoblast’s allogeneic mesenchymal precursor cell (MPC) product, in patients with end-stage ischemic heart failure with reduced ejection […]
Wegovy® receives FDA approval for cardiovascular risk reduction in adults with known heart disease and overweight or obesity
Wegovy® (semaglutide) injection 2.4 mg is the first-and-only medicine indicated for both reduction of the risk of major adverse cardiovascular events (MACE) such as death, heart attack, or stroke and for long-term weight management1 The approval is based on the results of SELECT, the…
InkSpace Imaging makes their advanced MRI coils available to Siemens Healthineers Magnetom Scanners
PLEASANTON, Calif., March 08, 2024 (GLOBE NEWSWIRE) — InkSpace Imaging proudly announces a major leap forward in advancing diagnostic imaging capabilities. Today, the company revealed the successful certification of its groundbreaking Snuggle™ and Silhouette™ MRI body arrays for compatibility with all Siemens Healthineers TIM 4G 3T Magnetom MRI scanners in […]
Getinge takes a leap forward in cardiovascular surgery with the 510(k) clearance for Vasoview Hemopro 3
GOTHENBURG, Sweden, March 8, 2024 /PRNewswire/ — Today, Getinge announces the U.S. Food and Drug Administration’s (FDA) 510(k) clearance of the Vasoview Hemopro 3, the latest addition to the medtech company’s endoscopic vessel harvesting (EVH) solutions. Designed with customer centricity…
Wellysis and Artella Solutions Launch Innovative Remote Cardiac Monitoring Service in the US.
SEOUL, South Korea, March 8, 2024 /PRNewswire/ — Wellysis, a digital healthcare company spun off from Samsung, has announced the launch of remote cardiac monitoring service in the US in partnership with Artella Solutions (ARTELLA). This collaboration builds on its FDA-cleared S-Patch…
Advancing Healthcare Access: Genesis MedTech Teams Up with Silk Road Medical to Serve Patients affected by Carotid Artery Disease in China
WUXI, China, March 7, 2024 /PRNewswire/ — Silk Road Medical (NASDAQ: SILK), a medical device company based in California USA and Genesis MedTech Group have signed an exclusive distribution agreement to introduce the TCAR® core products, ENROUTE® Transcarotid Neuroprotection System and…



