University of Florida Health (UF Health) enrolls first patient in the study to further understanding of how advanced donor organ preservation impacts pediatric patient outcomes CAMBRIDGE, Mass.–(BUSINESS WIRE)–Paragonix Technologies, Inc. today announces that the University of Florida Health (UF Health) is the first to enroll a pediatric heart transplant recipient […]
Coronary/Structural Heart
Armor Bionics Signs Exclusive 3D Printing Deal with Shapeways to Transform Surgical Pre-Planning
Shapeways to provide 3D printed advanced medical models to be used for pre-planning surgeries Parts printed and expected to be delivered within 24 hours to meet stringent medical timetables Complex 3D printed medical models created for patient-specific treatment 3D printed medical model helped plan life-saving surgery for eight-month-old Less surgery […]
AngelMed Announces First Commercial Implantation of Real-Time Heart Attack Warning System
The Guardian™ System continuously monitors heart rhythm, immediately alerting patients of any changes EATONTOWN, N.J., July 27, 2021 /PRNewswire/ — Angel Medical Systems, Inc., (dba AngelMed) a proactive diagnostics company focused on the advancement of long-term management of high-risk coronary disease, announced today the first commercial implantation and U.S. launch of its flagship […]
XyloCor Therapeutics Commences Phase 2 Component of Phase 1/2 EXACT Clinical Study of XC001 Gene Therapy for Refractory Angina
– Independent Data Monitoring Committee authorized proceeding to Phase 2 at highest dose level tested following review of clinical safety data from the Phase 1 dose escalation – Phase 2 clinical data readouts on safety and efficacy of XC001 anticipated in 2022 – Company plans to commence study startup of XC001 as an […]
Medtronic Launches Newest-Generation Drug Coated Balloon Catheter in Europe for Treatment of Coronary Artery Disease
Medtronic Prevail DCB™ Designed to Treat Complex Lesions with Superior Deliverability, Rapid Absorption of Paclitaxel DUBLIN, July 26, 2021 /PRNewswire/ — Medtronic plc (NYSE: MDT), the global leader in medical technology, today announced the launch of the Prevail™ drug coated balloon (DCB) Catheter in Europe following CE (Conformité Européene) mark. The newest coronary DCB on the market, […]
CathWorks FFRangio™ System Receives National Reimbursement Approval in Japan
KFAR-SABA, Israel and ALISO VIEJO, Calif., July 26, 2021 /PRNewswire/ — CathWorks announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved the application to provide reimbursement for the CathWorks FFRangio™ System, making it more broadly available for coronary artery disease decision-making in Japan. The CathWorks FFRangio™ System has already received regulatory approval […]
Beckman Coulter to Distribute BNP Cardiac Assay to Customers
– Beckman Coulter to take over distribution to customers of a B-type Natriuretic Peptide (BNP) assay, a marker of congestive heart failure on the company’s immunoassay platforms – This BNP assay for Beckman Coulter immunoassay analyzers, currently sold as TRIAGE® BNP by Quidel, will now be sold by Beckman Coulter […]
CARMAT Announces the First Human Implant of its Aeson® Artificial Heart in Germany
The implant was performed at Hannover Medical School PARIS–(BUSINESS WIRE)–Regulatory News: CARMAT (FR0010907956, ALCAR) (Paris:ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure, today announces the first implant of its Aeson® bioprosthetic […]
Study Data Presented at TVT on the Economics of Minimalist TAVR, PARTNER 3 Bicuspid TAVR
IRVINE, Calif., July 22, 2021 /PRNewswire/ — Edwards Lifesciences (NYSE: EW) today announced that clinical and economic results from the 3M (multidisciplinary, multimodality, but minimalist) Transcatheter Aortic Valve Replacement (TAVR) Economic Study and the PARTNER 3 Bicuspid Registry for SAPIEN 3 TAVR Study were presented at TVT 2021: The Structural Heart Summit. The 3M-TAVR study demonstrated positive […]
PaceMate™ and UNC School of Medicine Advance Cardiac Research with Data Partnership
BRADENTON, Fla.–(BUSINESS WIRE)–PaceMate™, the leading digital healthcare company in compliant cardiac data management, is pleased to announce a new strategic data research partnership with electrophysiologists, cardiologists, and the department research team at the University of North Carolina School of Medicine. The unmatched breadth of cardiac device data collected via PaceMate™’s […]