Coronary/Structural Heart

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 […]

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 […]

Late-Breaking Trial Data at TVT Demonstrate Sustained Safety and Performance of WATCHMAN FLX™ Left Atrial Appendage Closure Device

PINNACLE FLX study meets 24-month endpoint, reinforces positive 12-month outcomes with next-generation device for patients with non-valvular atrial fibrillation MARLBOROUGH, Mass., July 21, 2021 /PRNewswire/ — Today, Boston Scientific (NYSE: BSX) announced positive 24-month results from the PINNACLE FLX clinical trial assessing the safety and efficacy of the next-generation WATCHMAN FLX™ Left Atrial […]

BIOMODEX Technology Enables New Milestone in Interventional Cardiology

Physicians at Montreal Heart Institute used LAACS™ solution to simulate left atrial appendage occlusion, validating the company’s efforts to reduce surgical errors and improve outcomes BOSTON, July 21, 2021 /PRNewswire/ — BIOMODEX®, the leader in bio-realistic haptic simulators for patient-specific rehearsal and physician training, today announced that its LAACS™ (Left Atrial Appendage Closure System) solution […]

LEXEO Therapeutics Expands Cardiac Gene Therapy Pipeline with Acquisition of Stelios Therapeutics and its Gene Therapy Programs for Rare Cardiovascular Diseases

LEXEO obtains exclusive rights to three investigational AAV-mediated gene therapy programs for rare cardiac disorders, all of which have no existing disease-modifying treatments available Strategic acquisition expands LEXEO’s rare cardiac gene therapy pipeline making it one of the most extensive in the field NEW YORK, July 21, 2021 (GLOBE NEWSWIRE) […]