CAMBRIDGE, Mass.–(BUSINESS WIRE)–Paragonix Technologies, Inc. today announced clinical results presented during the Paragonix SherpaPak™ CTS 2019 International Heart Summit held during the International Society for Heart and Lung Transplantation (ISHLT) 2019 Annual Meeting in Orlando, FL. Five U.S. and European Centers shared clinical use experiences of the Paragonix SherpaPak™ Cardiac Transport System […]
Coronary/Structural Heart
Orchestra BioMed™ Receives FDA Breakthrough Device Designation for Virtue® Sirolimus-Eluting Balloon (SEB)
NEW HOPE, Pa., April 24, 2019 (GLOBE NEWSWIRE) — Orchestra BioMed, Inc. (“Orchestra BioMed” or the “Company”), a biomedical innovation company developing advanced therapeutic solutions to address major unmet healthcare needs, announced today that it has secured Breakthrough Device designation by the U.S. Food and Drug Administration (FDA) for its Virtue® Sirolimus-Eluting […]
Boston Scientific Receives FDA Approval for LOTUS Edge™ Aortic Valve System
MARLBOROUGH, Mass., April 23, 2019 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX) today announced it has received U.S. Food and Drug Administration (FDA) approval for the LOTUS Edge™ Aortic Valve System. Delivered via a minimally-invasive procedure, this transcatheter aortic valve replacement (TAVR) technology is approved for patients with severe aortic stenosis who are considered at […]
Surmodics Sublime™ Guide Sheath Receives FDA 510(k) Approval
EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (NASDAQ:SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Sublime™ guide sheath. The highly flexible, proprietary Xtreme® braid-reinforced Sublime sheath is designed to resist kinking […]
Microbot Medical Strengthens Global IP Portfolio with Canadian Notice of Allowance for a Patent Application for a Shunt Stenosis Prevention System
HINGHAM, Mass., April 23, 2019 (GLOBE NEWSWIRE) — As it continues to receive an overwhelming positive response from global jurisdictions, Microbot Medical Inc. (NASDAQ: MBOT) expands its IP portfolio as it receives a Notice of Allowance from the Canadian Intellectual Property Office for Patent Application No. 2,850,279, which pertains to […]
CHF Solutions to Sponsor CT Theatre Session, “Personalized Medicine: Improving Clinical Outcomes with Novel Fluid Management Strategies” Moderated by Renowned Cardiothoracic Surgeon Daniel Beckles, M.D., Ph.D., at the 2019 AATS Annual Meeting
Email Print Friendly Share April 23, 2019 08:30 ET | Source: CHF Solutions, Inc. EDEN PRAIRIE, Minn., April 23, 2019 (GLOBE NEWSWIRE) — CHF Solutions (Nasdaq: CHFS), today announced it will be sponsoring a CT Theatre Session at the American Association for Thoracic Surgery Annual Meeting on Monday, May 6, 2019, 1:00-1:30 pm at the […]
ARCA biopharma Announces Steering Committee of Leading International Cardiology and Electrophysiology Experts for PRECISION-AF Phase 3 Clinical Trial
WESTMINSTER, Colo., April 23, 2019 (GLOBE NEWSWIRE) — ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically-targeted therapies for cardiovascular diseases, today announced the initial members of the Steering Committee for PRECISION-AF, the Company’s planned Phase 3 trial evaluating Gencaro™ (bucindolol hydrochloride) as potentially the first genetically-targeted treatment […]
Infraredx, a Nipro Company, Announces FDA Approval of Expanded Label Claim for the Makoto™ Intravascular Imaging System
BURLINGTON, Mass.–(BUSINESS WIRE)–Infraredx, a Nipro Company, a pioneer in intravascular imaging for mapping coronary artery disease, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to expand the indications for use for its Makoto™ Intravascular Imaging System. The approval is based on the […]
VisCardia Announces Completion of Enrollment and Three Month Follow-Up Visits for Its VisONE® Heart Failure Pilot Study
PORTLAND, Ore.–(BUSINESS WIRE)–VisCardia Inc., a privately held medical device developer, announced today it has completed enrollment and three month follow-up visits of the company’s VisONE® implantable system pilot for medical refractory heart failure patients with reduced ejection fraction and preserved ventricular synchrony. The VisONE Heart Failure pilot is a prospective […]
Quantum Genomics Receives First Regulatory and Ethics Approvals to Initiate Phase IIb QUORUM Study of Firibastat in Heart Failure
PARIS and NEW YORK, April 17, 2019 (GLOBE NEWSWIRE) — Quantum Genomics (Euronext Growth: ALQGC, OTCQX: QNNTF), a biopharmaceutical company specializing in the development of a new drug class that directly targets the brain to treat resistant hypertension and heart failure, today announced the first regulatory and ethics approvals for its Phase […]



