TCTMD

FDA Expands Sapien 3 Indication to Aortic, Mitral Valve-in-Valve Replacement

The US Food and Drug Administration (FDA) has expanded the indication for the Sapien 3 transcatheter heart valve (Edwards Lifesciences) to include valve-in-valve replacement for high-risk patients ...
Seeking Alpha

FDA Approves Edwards Lifesciences' SAPIEN M3 Mitral Valve Replacement System as First Transseptal Transcatheter Therapy

IRVINE, Calif.--(BUSINESS WIRE)-- Edwards Lifesciences (EW) today announced the company’s SAPIEN M3 mitral valve replacement system is the first transcatheter therapy utilizing a transseptal approach ...
Yahoo Finance

Edwards receives CE mark for Sapien M3 mitral valve replacement device

Edwards Lifesciences has received Europe’s CE mark for its transcatheter mitral valve replacement system, Sapien M3, the company said Monday. The device is designed for people with symptomatic mitral ...
TCTMD

Sapien a ‘Viable and Durable’ Option in Transcatheter Pulmonary Valve Replacement

Off-label use of the Sapien and Sapien XT valves represents a “viable and durable option” for restoring pulmonary valve function in patients with right-ventricular outflow tract (RVOT) disorders, ...
Nasdaq

Edwards Lifesciences' SAPIEN M3 Mitral Valve Replacement System Wins FDA Approval

(RTTNews) - Edwards Lifesciences Corp. (EW) on Tuesday said its SAPIEN M3 mitral valve replacement system received U.S. Food and Drug Administration (FDA) approval for the treatment of mitral ...
MedPage Today

Sapien 3 Evolves Into Novel Mitral Valve Device

WASHINGTON -- A slight tweak to the Sapien 3 turned it into a device usable for transcatheter mitral valve replacement (TMVR), a first-in-human experience showed. By adding a new sealing skirt, ...
Yahoo Finance

Sapien valve performs equally well for small and large aortic annuli, Edwards finds

Edwards Lifesciences said Wednesday its transcatheter aortic valve replacement (TAVR) device is similarly effective in patients with small and large aortic annuli. Earlier this year, Medtronic linked ...
Forbes

FDA Approves The Sapien Transcatheter Heart Valve For High Risk Patients

The FDA today approved an expanded indication for Edwards Lifesciences' Sapien transcatheter heart valve (THV). The device can now be implanted in patients who are eligible for aortic valve ...
Orange County Business Journal

Edwards Sapien M3 Valve Gets FDA Approval

The FDA has approved Edwards Lifesciences Corp.’s Sapien M3 transcatheter mitral valve replacement system. The U.S. approval, announced last week, comes eight months after the device received CE Mark ...
Healio

Sapien XT valve gains European approval for transcatheter mitral, aortic valve-in-valve procedures

Please provide your email address to receive an email when new articles are posted on . Edwards Lifesciences Corporation announced that it has received CE Mark in Europe for valve-in-valve procedures ...
Forbes

Sapien Transcatheter Aortic Heart Valve Gains FDA Approval

After much anticipation and drama, the FDA has approved the Sapien transcatheter aortic heart valve. The news was announced late Wednesday afternoon by the FDA and by Edwards Lifesciences, the ...
FierceBiotech

Edwards' next-gen Sapien heart valve gains Japanese reimbursement

Japan granted an insurance reimbursement for the Sapien XT valve.--Courtesy of Edwards Lifesciences Edwards Lifesciences' ($EW) Sapien heart-valve revenue engine gets ...