Coronary/Structural Heart

Janssen Submits Supplemental NDA to FDA Seeking New Indications for XARELTO (rivaroxaban) for Patients With Chronic Coronary and/or Peripheral Artery Disease (CAD/PAD)

RARITAN, N.J., Dec. 11, 2017 /PRNewswire/ — Janssen Research & Development today announced it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for two new XARELTO® (rivaroxaban) vascular indications: reducing the risk of major cardiovascular (CV) events such as CV death, heart attack or stroke […]

The Lancet Publishes Twelve-Month Results for DESSOLVE III Highlighting MiStent® Performance in All-Comers Randomized Trial; MiStent Achieved Primary Endpoint vs Xience®

DURHAM, N.C., Dec. 6, 2017 /PRNewswire/ — Micell Technologies, Inc. announced that The Lancet has published data from the DESSOLVE III clinical trial. The study met its primary endpoint, showing non-inferior safety and effectiveness outcomes in a complex patient population for the MiStent® Sirolimus Eluting Absorbable Polymer Coronary Stent System (MiStent) versus the Xience® Everolimus Eluting […]

Edwards Lifescience Scoops Up Harpoon Medical for $100M

IRVINE, Calif., Dec. 6, 2017 /PRNewswire/ — Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced the acquisition of Harpoon Medical, a privately held medical technology company pioneering beating-heart repair for degenerative mitral regurgitation (DMR). Edwards announced a structured upfront investment […]

4C Medical’s Novel Transcatheter Mitral Valve Technology Awarded Best Technology Parade Presentation at ICI 2017

BROOKLYN PARK, Minn., Dec. 5, 2017 /PRNewswire/ — 4C Medical Technologies, Inc. (4C Medical), a developer of minimally invasive technologies for structural heart disease, today announced that its medical device for mitral regurgitation (MR) was awarded the Best Technology Parade Presentation at the International Conference for Innovations in Cardiovascular Interventions (ICI) held December 3-5, […]

Neovasc Reducer Featured in Live Case at ICI 2017

VANCOUVER, Dec. 6, 2017 /PRNewswire/ – Neovasc Inc. (“Neovasc” or the “Company“) (NASDAQ, TSX: NVCN) today reported its Neovasc Reducer™ (“Reducer”) medical device was featured in a “live case” broadcast at the 2017 Innovations in Cardiovascular Interventions (ICI) conference held in Tel Aviv, Israel.  In the live case broadcast to the conference from […]

CorInnova Awarded “2017 InnoSTARS” Prize for Its Non-Blood-Contacting, Soft Robotic Heart Assist Device as Alternative to LVADs for Treatment of Heart Failure

By Ronald Trahan, APR, Ronald Trahan Associates, 1-508-816-6730, rtrahan@ronaldtrahan.com HOUSTON, Dec. 4, 2017—CorInnova Inc., an emerging medical device company developing novel technology for the treatment of Heart Failure, announced today that it was awarded second prize in the “2017 InnoSTARS” life science competition for its EpicHeart™ soft-robotic heart assist device. […]

FDA Approves Amgen’s Repatha® (evolocumab) To Prevent Heart Attack And Stroke

THOUSAND OAKS, Calif., Dec. 1, 2017 /PRNewswire/ — Amgen (NASDAQ: AMGN) today announced that following priority review of its supplemental Biologics License Application, the U.S. Food and Drug Administration (FDA) approved Repatha® (evolocumab) as the first PCSK9 inhibitor to prevent heart attacks, strokes and coronary revascularizations in adults with established cardiovascular disease.1 “We are pleased […]

Corindus Partners With Houston Methodist DeBakey Heart & Vascular Center to Launch Premier Robotic Training Site for Physicians

WALTHAM, Mass.–(BUSINESS WIRE)– Corindus Vascular Robotics (NYSE American: CVRS), a leading developer of precision vascular robotics, announced today that Houston Methodist DeBakey Heart & Vascular Center, a leading cardiovascular center located in the Texas Medical Center, has launched the first vascular robotic program in the Houston area with the installation of two CorPath® GRX […]

Cordis and Medinol Announce FDA Approval of the Innovative EluNIR Drug-Eluting Stent System

DUBLIN, Ohio, Nov. 30, 2017 /PRNewswire/ — Cordis, a Cardinal Health company, and Medinol today announced United States Food and Drug Administration (FDA) approval of the EluNIR™ drug-eluting stent (DES) for the treatment of patients with narrowing or blockages to their coronary arteries. The EluNIR™ stent system is designed with a novel metallic […]

China successfully completes the country’s first human implantation of a retrievable transcatheter aortic valve

HANGZHOU, China, Nov. 28, 2017 /PRNewswire/ — The first human implantation of the VenusA Plus retrievable valve system was completed successfully at the Second Affiliated Hospital of Zhejiang University School of Medicine (SAHZU) on November 23, 2017. Prof. Wang Jian‘an, president of SAHZU, announced that China has completed its first successful human implantation of a retrievable […]