Coronary/Structural Heart

Ortho Receives CE Mark for Enhanced VITROS® Immunodiagnostic Products NT-proBNP II Assay, an Aid in Diagnosing and Assessing Heart Failure

RARITAN, N.J., July 23, 2019 /PRNewswire/ — Ortho Clinical Diagnostics, a global leader of in vitro diagnostics, announced the CE Mark of an enhanced version of its VITROS® NT-proBNP II assay, part of Ortho’s expansive cardiac menu. The analytical characteristics and clinical performance of the VITROS NT-proBNP II assay allow clinicians to efficiently assess […]

SINOMED® Concludes Enrollment of the PIONEER III Randomized, Pivotal Study of the BuMA Supreme® Coronary Drug-Eluting Stent

TIANJIN, China, July 23, 2019 /PRNewswire/ — In a significant milestone toward obtaining key regulatory approvals for the BuMA Supreme Drug-Eluting Stent (DES) System, SINOMED has completed enrollment in the PIONEER III randomized, controlled clinical trial.  The PIONEER III trial is designed to assess the safety and effectiveness of the BuMA Supreme […]

MyoKardia Announces HCM Program Updates: Accelerates Timing for Mavacamten Topline Phase 3 Data; Re-acquires U.S. Royalty Rights to HCM Programs from Sanofi

SOUTH SAN FRANCISCO, Calif., July 18, 2019 (GLOBE NEWSWIRE) — MyoKardia, Inc. (Nasdaq: MYOK) today announced updates related to its hypertrophic cardiomyopathy (HCM) treatment portfolio, including lead therapeutic candidate, mavacamten. Patient screening has closed for the Phase 3 EXPLORER-HCM registrational clinical study to assess the effect of mavacamten in treating […]

New study finds both components of blood pressure predict heart attack, stroke risk

OAKLAND, Calif., July 17, 2019 /PRNewswire/ — Both numbers in a blood pressure reading — the “upper” systolic and the “lower” diastolic — independently predicted the risk of heart attack or stroke in a very large Kaiser Permanente study that included more than 36 million blood pressure readings from more than 1 […]

Corindus Adds Two New CorPath GRX Installations to HCA Healthcare Facilities

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 it has installed CorPath® GRX Systems in two new hospitals affiliated with one of the nation’s largest hospital networks, HCA Healthcare. The new systems are now installed in hospital locations […]

Ambrx to receive milestone payment from Bristol-Myers Squibb for the initiation of Phase 1 Clinical Trial of a long-acting Relaxin derivative

SAN DIEGO, July 16, 2019 /PRNewswire/ — Ambrx Inc. today announced that Bristol-Myers Squibb Company (“BMS”) has initiated a phase I clinical trial to evaluate the safety, pharmacokinetics and pharmacodynamics of long-acting Relaxin for the potential treatment of heart failure (“HF”). Long-acting Relaxin is an investigational biologic produced using Ambrx’ proprietary expanded genetic code […]

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 […]