Posts Tagged ‘CE’
On-X LTI to present its newest advance in heart valve technology at AATS
On-X Life Technologies to present its newest advance in heart valve technology at “94th Annual Scientific Meeting” of the American Association for Thoracic Surgery (AATS) in Toronto AUSTIN, TX — April 24, 2014 — Privately held On-X® Life Technologies, Inc. (On-X LTI) announced today that it will present the results of the PROACT1 clinical trial…
Read MoreOn-X LTI to present its newest advance in heart valve technology
On-X Life Technologies to present its newest advance in heart valve technology at the Asian Society for Cardiovascular and Thoracic Surgery (ASCVTS) in Istanbul, Turkey “We are excited about introducing the On-X® Plus 1.5™ Aortic Heart Valve to this important surgical society. This valve represents a new paradigm by which clinicians can manage their patients…
Read MoreOn-X Life Technologies to launch its On-X Plus 1.5 Aortic Heart Valve
On-X Life Technologies to launch its On-X® Plus 1.5™ Aortic Heart Valve at Annual Meeting of the Society for Cardiothoracic Surgery (SCS) in Great Britain & Ireland “The On-X® Plus 1.5™ Aortic Heart Valve allows clinicians to maintain patients on a lower dose of blood thinner, which has been shown to result in greater than…
Read MoreClinical Update Forty-Six: Recently Approved in Europe
Recently Approved in Europe — Lower Anticoagulation Maintenance of Aortic Heart Valve Recipients!1 Introducing the On-X® Plus 1.5™ Aortic Heart Valve: Significantly reduced bleeding for On-X aortic heart valve patients does not increase the stroke rate.2 European aortic valve patients can now take less warfarin for lowered bleeding rates The On-X valve is the…
Read MoreOn-X Life Technologies reports CE mark approval
On-X Life Technologies reports CE mark approval to sell its mechanical aortic heart valve with an expanded labeling claim: a reduction in the required use of blood thinners “This approval allows European clinicians to maintain patients on a lower dose of anticoagulant, which has been shown in a multicenter clinical trial (PROACT: Prospective On-X Anticoagulation…
Read MoreOn-X Life Technologies Submits for FDA/CE Approval
Reduced Anticoagulation Indication for On-X Aortic Heart Valve If approval is received, the On-X valve will become the first aortic valve that allows patients to be maintained at levels of anticoagulation below currently recommended professional society guidelines, helping to lessen anticoagulation – related complications AUSTIN, TX – October 22, 2012 – On-X® Life Technologies, Inc.…
Read MoreEU Grants CE Mark for the On-X Valve
The TUV in Munich, Germany granted CE Mark for the On-X valve. AUSTIN, TX — July 24, 1998 – The TUV in Munich, Germany granted CE Mark for the On-X valve. The valves are now available for use in countries of the European Union.
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