US-based On-X Life Technologies has launched CHORD-X for the repair and replacement of mitral valve chordae tendeneae. The new device, which comes with two needle choices including a 3/8 circle needle and a 1/2 circle needle, is made of ...
Tags: On-X Life Technologies, CHORD-X, mitral valve chordae tendeneae
St Jude Medical has received CE mark approval for its Portico Transcatheter aortic heart valve which is designed to treat patients with severe aortic stenosis who are at intermediate risk for undergoing open-heart surgery. The 23 mm ...
Tags: CE mark, aortic heart valve, medical device, Medical equipment
Sorin Group has announced the US launch of a Mitroflow Valsalva Conduit graft, designed for use in combination with a Mitroflow pericardial aortic valve. The Conduit graft enables surgeons to replace simultaneously the ascending aorta and ...
Tags: Sorin, launch, Conduit graft, combination, Mitroflow graft
Edwards Lifesciences is set to begin clinical trial to assess its Intuity valve system, following an investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA). The prospective, multi-center study, ...
Tags: clinical trial, Intuity valve system, FDA
Sorin Group has obtained marketing rights to its Mitroflow aortic pericardial heart valve in Japan, following the approval from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). The bioprosthetic heart valve, which is ...
Tags: PMDA, heart valve, Japan Lifeline
Colibri Heart Valve in the US has treated the first patient with its proprietary 24mm Colibri transcatheter aortic valve implantation(TAVI)system,as part of first-in-human feasibility study. The ...
Tags: Colibri Heart Valve, TAVI system, open-heart valve replacement, cost
Janssen Research & Development has submitted a supplemental new drug application (sNDA) with FDA, seeking approval to use Xarelto (rivaroxaban), an oral anticoagulant, to reduce the risk of stent thrombosis in patients with acute coronary ...
St Jude Medical has implanted the first patient with its Portico Transcatheter aortic heart valve designed to treat patients with severe aortic stenosis who are at high risk of needing open-heart surgery, using the Transapical delivery ...
Tags: portico transcatheter aortic heart valve, St Jude Medical
The US Food and Drug Administration (FDA) has granted a conditional investigational device exemption (IDE) approval to Edwards Lifesciences' new GLX technology platform. Based on the IDE approval, the company will commence a clinical ...
Tags: FDA, IDE, Lifesciences, GLX technology