SANTA CLARA, Calif., Jan. 14, 2019 (GLOBE NEWSWIRE) — Shockwave Medical, Inc., a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease, has initiated its U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) study – DISRUPT CAD III – for the […]
Coronary/Structural Heart
Matinas BioPharma Announces a Research Evaluation with Top Global Pharma Company Based on Its Proprietary Drug Delivery Platform
BEDMINSTER, N.J., Jan. 10, 2019 (GLOBE NEWSWIRE) — Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a clinical stage biopharmaceutical company, today announced they have signed an agreement with an undisclosed top global pharmaceutical company aimed to evaluate synergistic effects of Matinas’ lipid-nano-crystal (“LNC”) platform delivery technology with their partner’s nucleic acid polymer […]
Amgen Makes All Repatha® (evolocumab) Device Options Available In The US At A 60 Percent Reduced List Price
THOUSAND OAKS, Calif., Jan. 7, 2019 /PRNewswire/ — Amgen (NASDAQ: AMGN) today announced that as part of the Company’s commitment to improve patient affordability for an innovative biologic medicine for people with high cholesterol who are at risk for heart attacks and strokes, all Repatha® (evolocumab) device options, including the Pre-Filled Syringe and Pushtronex® (on-body infusor […]
Microbot Medical Announces FDA Pre-Submission Milestones for 2019
HINGHAM, Mass., Jan. 07, 2019 (GLOBE NEWSWIRE) — Microbot Medical Inc. (Nasdaq CM: MBOT) announced today anticipated operational and product milestones, including pivotal pre-clinical study and FDA pre-submission milestones, for 2019. The progress and successful execution of key objectives in 2018, which included, among other things, Microbot’s successful completion of […]
Phase 3 Trial of Mesoblast’s Cell Therapy in Chronic Heart Failure Completes Recruitment
NEW YORK and MELBOURNE, Australia, Jan. 07, 2019 (GLOBE NEWSWIRE) — Mesoblast Limited (Nasdaq:MESO; ASX:MSB), world leader in development and commercialization of allogeneic (off-the-shelf) cellular medicines, today announced that it has completed patient recruitment in the events-driven Phase 3 trial of its product candidate Revascor (MPC-150-IM) for advanced chronic heart failure. Mesoblast Chief […]
REVA Expands Geographic Footprint to Seven New Countries
SAN DIEGO, Jan. 07, 2019 (GLOBE NEWSWIRE) — REVA Medical, Inc. (ASX: RVA) (“REVA” or the “Company”), a leader in bioresorbable polymer technologies for vascular applications, announced the geographic expansion of its commercial operations in seven European countries with the addition of four new distribution partnerships. These partnerships will allow […]
JC Medical Announces First United States Treatment with the J-Valve TAVR Device
BURLINGAME, Calif.–(BUSINESS WIRE)–JC Medical today announced the successful treatment of the first U.S. patient with the company’s first-of-its-kind transfemoral TAVR device, the J-Valve TF System. The patient was treated at The Christ Hospital – Cincinnati, Ohio by Dean Kereiakes, MD, FACC, FSCAI, Medical Co-Director of the Lindner Research Center, working […]
Matinas BioPharma Appoints Keith A. Kucinski, CPA, MBA as Chief Financial Officer
BEDMINSTER, N.J., Jan. 03, 2019 (GLOBE NEWSWIRE) — Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a clinical-stage biopharmaceutical company, today announced that it has appointed Keith A. Kucinski, CPA, MBA as Chief Financial Officer. Mr. Kucinski brings to Matinas over 20 years of diversified and broad finance expertise with demonstrated leadership and […]
Edwards’ SAPIEN 3 Ultra Transcatheter Heart Valve Receives FDA Approval
IRVINE, Calif., Dec. 28, 2018 /PRNewswire/ — Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced that the SAPIEN 3 Ultra system has received U.S. Food and Drug Administration (FDA) approval for transcatheter aortic valve replacement in severe, symptomatic aortic stenosis patients […]
Cardiovascular Systems, Inc. Announces First Patients Treated in United States with OrbusNeich Teleport® Microcatheter
ST. PAUL, Minn.–(BUSINESS WIRE)–Cardiovascular Systems, Inc. (CSI®) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, today announced that the first patients in the United States were treated using the OrbusNeich® Teleport Microcatheter (Teleport), which recently received U.S. Food […]



