Coronary/Structural Heart

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, […]

Cordis/Medinol DES implanted in the U.S.

N.Y. Presbyterian/Columbia implant EluNIR stent Cordis and Medinol Announce First U.S. Commercial Implants of Innovative EluNIR™ Drug-Eluting Stent – by CardiovascularBusiness DUBLIN, Ohio, January 11, 2018 — Cordis, a Cardinal Health company, and Medinol today announced that the first commercial cases using the EluNIR™ drug-eluting stent (DES) in the United States […]

SentreHEART Announces Participation at International AF Symposium 2018

REDWOOD CITY, Calif.–(BUSINESS WIRE)–SentreHEART, Inc., the manufacturer of the LARIAT® Suture Delivery Device (LARIAT) will be participating in the 23rd Annual International AF Symposium being held in Orlando, FL, January 11- 13, 2018. The symposium’s agenda will include several sessions dedicated to exploring device-based options for Left Atrial Appendage (LAA) closure […]

Svelte Medical Systems Announces First Patient Enrolled in Pivotal OPTIMIZE Study

NEW PROVIDENCE, N.J.–(BUSINESS WIRE)– The Christ Hospital, Lindner Research Center in Cincinnati, Ohio, enrolled the first patient in Svelte Medical System’s OPTIMIZE clinical study, designed to further assess the safety and effectiveness of the Svelte Drug-Eluting Stent (DES) Integrated Delivery System (IDS) and Rapid Exchange (RX) platforms. The randomized, controlled […]

Micell Technologies’ Positive Five-Year Data Published for MiStent in EuroIntervention

DURHAM, N.C., Jan. 9, 2018 /PRNewswire/ — Micell Technologies announced the recent online publication of five-year data from the DESSOLVE I and II trials. The report, “Long-term clinical outcomes of a crystalline sirolimus-eluting coronary stent with a fully bioabsorbable polymer coating: five-year outcomes from the DESSOLVE I and II trials” was peer […]

Neovasc Reports Tiara’s Clinical Case Load Accelerating

VANCOUVER, Jan. 8, 2018 /PRNewswire/ – Neovasc Inc. (“Neovasc” or the “Company“) (NASDAQ, TSX: NVCN) today provided an update on its clinical program for the Tiara™ (“Tiara”) valve, a self-expanding mitral bioprosthesis for transcatheter implantation in patients with Mitral Regurgitation (“MR”), one of the most prevalent valvular heart diseases in western countries.  MR […]

BioCardia Submits Clinical Trial to FDA for New Indication of Chronic Myocardial Ischemia for CardiAMP Cell Therapy

SAN CARLOS, Calif.–(BUSINESS WIRE)-–BioCardia, Inc. [OTC: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today reported filing a second Investigational Device Exemption with the FDA for the CardiAMP Chronic Myocardial Ischemia Trial to treat patients with refractory angina. This second potential indication for CardiAMP investigational cell therapy of […]