Coronary/Structural Heart

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 […]

Venus Medtech Completes Merger with Keystone Heart, LTD

HANGZHOU, China and CAESAREA, Israel and TAMPA, Fla., Dec. 26, 2018 /PRNewswire/ — Venus Medtech (Hangzhou) Inc., the preeminent Chinese transcatheter heart valve company, today announced it has closed its Merger with Keystone Heart Ltd., a privately-held medical device company and makers of TriGUARD 3™. The Merger provides Venus Medtech with TriGUARD 3, the first Cerebral Embolic Protection Device designed […]

CathWorks FFRangio™ System Receives U.S. FDA Clearance

KFAR-SABA, Israel & ALISO VIEJO, Calif.–(BUSINESS WIRE)–CathWorks announced today that its FFRangio™ System received United States Food & Drug Administration (FDA) 510(k) clearance. The FFRangio system demonstrated accuracy versus the invasive FFR wire in a blinded comparative study, FAST-FFR. The results of the FAST-FFR pivotal study were used to establish substantial […]

Acasti Pharma Achieves Planned Enrollment Targets for TRILOGY Phase 3 Trials of CaPre® in Patients with Severe Hypertriglyceridemia

LAVAL, Québec, Dec. 20, 2018 (GLOBE NEWSWIRE) — Acasti Pharma Inc. (“Acasti or the “Company”) (NASDAQ: ACST – TSX-V: ACST), a biopharmaceutical innovator focused on the research, development and commercialization of its prescription drug candidate CaPre® (omega-3 phospholipid) for the treatment of severe hypertriglyceridemia (HTG), today announced it has reached […]