Coronary/Structural Heart

Digital therapeutics leader Biofourmis to take part in pioneering heart failure research with Yale University-Mayo Clinic Center of Excellence in Regulatory Science and Innovation (CERSI)

BOSTON, July 16, 2019 /PRNewswire/ — Biofourmis, a fast-growing global leader in digital therapeutics, has entered a research partnership with the Yale University-Mayo Clinic Center of Excellence in Regulatory Science and Innovation (CERSI). Biofourmis’ mobile platform BiovitalsHFTM will be leveraged in a study of patients with heart failure to monitor functional capacity and quality of life […]

Neovasc Provides Further Update on Reducer™ Program for Treatment of Refractory Angina

Pending U.S. Food and Drug Administration (“FDA”) Humanitarian Use Device (“HUD”) Classification and Approval as a HUD, Company Expects to Begin Commercializing Reducer in U.S. by Early 2020 A potential HUD Reducer designation for Canadian Cardiovascular Society (“CCS”) Class IV would, by statute, allow the treatment of a limited number of […]

FDA approves Bayer’s Gadavist® (gadobutrol) injection as the first and only contrast agent for use in cardiac MR in adult patients with known or suspected coronary artery disease

WHIPPANY, N.J., July 15, 2019 /PRNewswire/ — Bayer announced today the U.S. Food and Drug Administration (FDA) has approved Gadavist® (gadobutrol) injection for use in cardiac magnetic resonance (MR) imaging to assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD). Gadavist is […]

Abbott Receives U.S. Approval of Next-Generation MitraClip®, Bringing New Enhancements to Abbott’s Leading MitraClip Platform

ABBOTT PARK, Ill., July 15, 2019 /PRNewswire/ — Abbott (NYSE: ABT) today announced the company has received U.S. Food and Drug Administration (FDA) approval for the most advanced MitraClip™ heart valve repair device to treat mitral regurgitation. The latest approval for the fourth-generation MitraClip device, MitraClip G4, puts new enhancements into the hands of […]

MeRes100 BRS – the World’s First Thin Strut Sirolimus-Eluting Bioresorbable Vascular Scaffold – Shows Consistent Long-term Positive Safety With Consistent Low MACE rates and Zero Scaffold Stent Thrombosis for Patients With Coronary Artery Disease

LONDON, July 11, 2019 /PRNewswire/ — Meril’s recently CE-approved MeRes100, used for the treatment of de-novocoronary artery lesions, has demonstrated zero scaffold thrombosis and very low Major Adverse Cardiac Event (MACE) rate of 1.87% at three years as shown in MeRes-1 and 1.61% in MeRes-1 Extend at two years. “First generation bioresorbable scaffolds have not […]

LivaNova Celebrates 25 Years of Vagus Nerve Stimulation Therapy

LONDON–(BUSINESS WIRE)–LivaNova PLC (NASDAQ:LIVN), a market-leading medical technology company, is celebrating the 25th anniversary of its Vagus Nerve Stimulation Therapy® (VNS Therapy) System. This clinically proven, safe and effective therapy is used for the treatment of Drug-Resistant Epilepsy (DRE), Treatment-Resistant Depression (TRD) and for the delivery of Autonomic Regulation Therapy for […]

Corindus Announces First Commercial Installation of CorPath® GRX System in South America

WALTHAM, Mass.–(BUSINESS WIRE)–Corindus Vascular Robotics, Inc. (“Corindus” or the “Company”) (NYSE American: CVRS), a leading developer of precision vascular robotics, announced today that Albert Einstein Jewish Hospital (Hospital Israelita Albert Einstein) in São Paulo, Brazil has become the first hospital in the Southern Hemisphere to implement Corindus’ CorPath GRX System. Ranked as the […]

Resverlogix’s BETonMACE Phase 3 Epigenetics Trial Completes Final Safety Visits

CALGARY, Alberta, July 08, 2019 (GLOBE NEWSWIRE) — Resverlogix Corp. (“Resverlogix” or the “Company”) (TSX:RVX) is pleased to announce today that all patients active in BETonMACE, the Company’s event-based, phase 3 registration trial, recently completed their final, follow-up safety visits, marking another important step towards trial completion. Given the remaining steps […]