Coronary/Structural Heart

Baylis Medical Announces First Clinical Use of the VersaCross® Large Access Solution to Deliver Large Bore Therapy Solutions

TORONTO, July 29, 2021 /PRNewswire/ – Baylis Medical announced today the first clinical use of the VersaCross® Large Access Solution. The new solution includes the world’s first 3-in-1 RF wire paired with a seamless shapeable dilator designed to optimize tissue dilation for large sheath procedures, including left atrial appendage closure, transvenous mitral […]

Biofourmis Earns FDA’s First-Ever Breakthrough Device Designation for a Novel Digital Therapeutic for Heart Failure

BiovitalsHF® Approved for Expedited FDA Review Process as a First-in-Class DTx for Heart Failure that Augments Traditional Guideline-Directed Medical Therapy BOSTON, July 29, 2021 /PRNewswire/ — Biofourmis, a Boston-based global leader in virtual care and digital therapeutics, announced today its BiovitalsHF® solution is the first-ever heart failure digital therapeutic to receive a Breakthrough Device […]

Cohere Health Announces a Groundbreaking Collaboration with American College of Cardiology to Advance High-Quality Care

Cohere Health adds care-pathway-based cardiology solution to its transformative digital prior authorization product line BOSTON, July 28, 2021 /PRNewswire/ — Cohere Health, an emerging high-growth digital health company, today announced a new solution for health plans in partnership with the American College of Cardiology (ACC) that actively engages physicians, patients, health plans and […]

Paragonix Technologies Announces Global Registry for Pediatric Donor Heart Preservation; Enrolls First Patient

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 […]

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 […]