Century Medical, the Japanese partner of TriReme Medical, has obtained Shonin approval for the GliderXtreme PTA catheter, which is designed for the treatment of peripheral arterial blockages. GliderXtreme has a low-profile nitinol shaft ...
Tags: Century Medical, PTA Catheter
W. L. Gore & Associates (Gore) has obtained an approval from the US Food and Drug Administration (FDA) for its 25cm GORE VIABAHN endoprosthesis with heparin bioactive surface. The 25cm Gore Viabahn endoprosthesis is intended to treat ...
Tags: disease heal, health, cure, fda
Global medical technology company ArjoHuntleigh has introduced the Dopplex Ability, an ankle brachial index (ABI) screening device. ABI measurements are used to predict the severity of peripheral arterial disease (PAD). The Dopplex ...
Cook Medical has announced that effective October 1, 2013, its Zilver PTX drug-eluting peripheral stent qualifies for new-technology add-on payments under Medicare’s hospital inpatient prospective payment system. In order to qualify ...
Tags: Cook Medical, clinical improvement
Covidien has completed patient enrollment in its VISIBILITY and DURABILITY Iliac stent clinical study series. The prospective, multinational, multicenter studies, which have enrolled 150 patients from 23 centers in the US and Europe, are ...
Global healthcare products provider Covidien has singed an agreement to acquire CV Ingenuity for undisclosed sum. The transaction is also expected to increase Covidien's research and development expenditures to fund the clinical ...
Tags: Global healthcare, Covidien, CV Ingenuity, DCB technology
US-based Riverside Methodist Hospital has implanted the first US patient with Cook Medical's Zilver PTX drug-eluting peripheral stent, designed for use in above-the-knee femoropopliteal artery. The stent, which is coated with paclitaxel ...
Tags: Methodist Hospital, Cook's Zilver PTX Stent, Medicak Device
Austin Heart, a provider of cardiac and vascular services, has started enrolling peripheral arterial disease (PAD) patients for Avinger's Connect II trial. The multi-center, non-randomized and prospective trial is designed to evaluate ...
Tags: Austin Heart, PAD patients, Connect II trial, peripheral arterial disease
Cook Medical has received the regulatory approval from the US Food and Drug Administration (FDA) for its Zilver PTX drug-eluting peripheral stent, designed for treating peripheral arterial disease (PAD) in the superficial femoral artery. ...
Tags: Cook Medical, FDA, peripheral arterial disease, clinical product
C. R. Bard's Lutonix technology center has completed enrolling patients in its pivotal investigational device exemption (IDE) LEVANT 2 trial, designed to evaluate Lutonix drug coated PTA dilatation catheter (DCB) as a treatment for ...
Tags: pivotal investigational device, drug coated PTA dilatation catheter
The FDA has approved Mylan Pharmaceuticals' abbreviated new drug application (ANDA) for Clopidogrel tablets USP, 75mg and 300mg. The generic version of Sanofi-Aventis' Plavix is indicated for acute coronary syndrome and for patients with ...
Tags: Clopidogrel Tablets, Mylan Pharmaceuticals, drug application