Author: Ken Dropiewski

Vascular Graft Solutions Acquires the Intellectual Property Developed by Kipsbay Medical Inc.

TEL AVIV, Israel, Jan. 6, 2020 /PRNewswire/ — Vascular Graft Solutions (VGS) announces on the acquisition of several patent families from NEOGRAFT Technologies Inc. which include patents that were previously developed and owned by Kipsbay Medical Inc, a pioneer in the field of venous external stenting and vascular engineering. The patents portfolio, which includes […]

Tom Sheehy Joins Preventice Leadership Team as EVP and Chief Commercial Officer

MINNEAPOLIS, Jan. 6, 2020 /PRNewswire/ — Preventice Solutions announced today the appointment of Tom Sheehy as executive vice president (EVP) and chief commercial officer (CCO). In this role, Sheehy will lead the Preventice commercial organization, including sales, marketing and product management. Sheehy joins Preventice from Medtronic, where he recently served as a senior area sales […]

Dr. Nalini Rajamannan Comments on FDA Congressional Letter to Senate Finance Committee After Kaiser Health News Reveals Access to Exempt FDA Database

SHEBOYGAN, Wisconsin, Jan. 6, 2020 /PRNewswire/ — Dr. Nalini Rajamannan — a specialist for patients with valvular heart disease in Most Sacred Heart of Jesus Cardiology, Sheboygan, WI — confirms today that patients finally may get answers about whether medical devices placed in their bodies are tested and safe, as the Food and Drug Administration […]

Cytokinetics Announces Start of Redwood-HCM, a Phase 2 Clinical Trial of CK-3773274

Next-Generation Cardiac Myosin Inhibitor Advances In Clinical Trial Designed to Assess Effects Using Two-Week Dose Titration Schedule SOUTH SAN FRANCISCO, Calif., Jan. 06, 2020 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that REDWOOD-HCM (Randomized Evaluation of Dosing With CK-274 in Obstructive Outflow Disease in HCM) has opened to enrollment. REDWOOD-HCM is a Phase 2 clinical […]

Novartis successfully completes acquisition of The Medicines Company, adding a potentially first-in-class, investigational cholesterol-lowering therapy inclisiran

Over 50 million secondary prevention patients worldwide with atherosclerotic cardiovascular disease (ASCVD) or familial hypercholesterolemia (FH) on current standard of care do not achieve LDL cholesterol (LDL-C) goal and remain at increased risk of cardiovascular events1 The Medicines Company submitted the New Drug Application (NDA) for inclisiran to the FDA […]

TransEnterix, Inc. Announces Appointment of Interim Chief Financial Officer

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–TransEnterix, Inc. (NYSE American:TRXC), a medical device company that is digitizing the interface between the surgeon and the patient to improve minimally invasive surgery, today announced that Brett Farabaugh has joined as interim Chief Financial Officer, effective January 2, 2020, replacing Joe Slattery who retired December […]

Neovasc Announces $10 Million Registered Direct Offering Priced At-The-Market

Vancouver, Canada, Jan. 02, 2020 (GLOBE NEWSWIRE) — via NEWMEDIAWIRE — Neovasc Inc. (“Neovasc” or the “Company”) (NASDAQ: NVCN / TSX: NVCN) announced today that it has entered into definitive agreements with certain institutional investors for the sale of an aggregate of 2,418,322 series A units (“Series A Units”) and series […]

VASCEPA® Approved in Canada to Reduce the Risk of Cardiovascular Events

VASCEPA becomes the first and only Health Canada approved medication for reducing cardiovascular risk beyond cholesterol lowering therapy in the studied high-risk patients approved for treatment Commercial launch expected in mid-February 2020 by Amarin’s commercial partner for Canada VASCEPA approval was supported by clinical results from the REDUCE-IT® trial which included […]

Neovasc Submits Premarket Approval Application to FDA for Neovasc Reducer™

VANCOUVER, Dec. 31, 2019 (GLOBE NEWSWIRE) — via NEWMEDIAWIRE — Neovasc Inc. (“Neovasc” or the “Company”) (NASDAQ, TSX: NVCN), a leader in the development of minimally invasive transcatheter mitral valve replacement technologies and in the development of minimally invasive devices for the treatment of refractory angina, today announced the submission of a Premarket […]

Stryker launches voluntary field action for specific units of the LIFEPAK® 15 monitor/defibrillator

KALAMAZOO, Michigan, USA, Dec. 27, 2019 /PRNewswire/ — Stryker announced today that the company is launching a voluntary field action on specific units of the LIFEPAK 15 monitor/defibrillators. The company is notifying a population of LIFEPAK 15 customers of an issue that may cause their devices to fail to deliver a defibrillation […]