EDEN PRAIRIE, Minn.–(BUSINESS WIRE)– SurModics (NASDAQ:SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, announced it has received Food and Drug Administration (FDA) 510(k) clearance for its Telemark™ .014” coronary and peripheral support microcatheter. The Company is making this product available for U.S. distribution in the […]
Coronary/Structural Heart
Baxter Announces U.S. FDA Approval of Ready-to-Use Cardiovascular Medication Bivalirudin
DEERFIELD, Ill.–(BUSINESS WIRE)–Baxter International, Inc. (NYSE: BAX), a global leader in sterile medication production and delivery, today announced the FDA approval of Bivalirudin in 0.9 percent Sodium Chloride Injection (bivalirudin). Bivalirudin is a specific and direct thrombin inhibitor indicated for use as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI), a common […]
Non-Culprit Lesions Cause 2x More Subsequent MIs than PCI’d Lesions
by Ken Dropiewski, Prime-Core Executive Search (ken@prime-core.com) A new study published in the Journal of the American Heart Association shows that AMIs following a percutaneous coronary intervention (PCI) is twice as likely to originate from untreated lesions versus previous stented lesions. Interesting since this information seems to differ from previous studies such as PROSPECT […]
Cardiovascular Systems Expands Product Portfolio to Further Support Peripheral and Coronary Interventions
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 two new partnerships broadening the company’s product portfolio. CSI is now the exclusive U.S. distributor of OrbusNeich balloon products. Additionally, the […]
Neovasc Reducer Featured in Live Case at Berlin Symposium
VANCOUVER, Jan. 18, 2018 /PRNewswire/ – Neovasc Inc. today reported its Neovasc Reducer™ (“Reducer”) was featured in a “live case” broadcast to more than 800 participants at the Kardiologie Symposium 2018 held in Berlin, Germany. The successful live case was performed by Dr. Spyrantis and Professor Banai in the Sana-Klinikum Lichtenberg. “The […]
International Biophysics Wins FDA Nod for the FloPump 32 Centrifugal Heart Pump
AUSTIN, Texas, Jan. 17, 2018 /PRNewswire/ — International Biophysics Corporation, a global medical device manufacturer based in Austin, Texas, announced they have received FDA A 510k clearance for their FloPump 32 centrifugal disposable heart pump. The FloPump 32 is one of the smallest centrifugal pumps in the world at 32ml prime. The FloPump […]
Novoheart Files Patent Application on Three-Tier Drug Screening System After Successful Collaboration Contract with Global Pharma Company
VANCOUVER, BRITISH COLUMBIA — (Marketwired) — Jan 16, 2018 — Novoheart(“Novoheart” or the “Company”) (TSX VENTURE: NVH) today announced that it has filed a provisional patent application with the United States Patent and Trademark Office (USPTO) for a three-tiered drug screening system with enhanced capability, sensitivity and accuracy for detecting pharmacological effects […]
DAN-NICADII study to expand the applicability of the non-invasive Acarix CADScor®System for rapid ruling out Coronary Artery Disease
Handheld system rules out coronary arterial stenosis, saving valuable time in frontline triage and avoiding the need for expensive diagnostics. Acarix AB (publ) (“Acarix” or the “Company”) announced the initiation of a multi-center trial of its handheld CADScor®System for non-invasive, non-radiation acoustic detection of Coronary Artery Disease (“CAD”). The results […]
LivaNova Initiates BELIEVE Aortic Heart Valve Study in the U.S. and Canada
LONDON–(BUSINESS WIRE)– LivaNova PLC (NASDAQ:LIVN) (“LivaNova” or the “Company”), a market-leading medical technology company, today announced that the first patient has been enrolled in the Behavior of Valve Leaflets and the Incidence of Reduced Mobility Post-Surgical Aortic ValveImplant Study (“BELIEVE”). This study is a post-market, prospective, interventional, multi-center trial designed to report the overall incidence […]
Resverlogix Receives FDA Protocol Acceptance for the Ongoing Phase III BETonMACE Trial
CALGARY, Alberta, Jan. 11, 2018 (GLOBE NEWSWIRE) — Resverlogix Corporation (“Resverlogix” or the “Company”) (TSX:RVX) and the Resverlogix BETonMACE Clinical Steering Committee (CSC), represented by Professor Kausik Ray (Chair), are pleased to announce the FDA acceptance of the Company’s Phase 3 BETonMACE trial Protocol amendments. On behalf of all members of the BETonMACE CSC, […]



