Informativo

FDA Expands TAVR Devices’ Indications To Severe Aortic Stenosis Patients At Low Surgical R

19/08/2019

FDA Expands TAVR Devices’ Indications To Severe Aortic Stenosis Patients At Low Surgical Risk

MedPage Today (8/16, Lou) reported the FDA “has expanded the indications for Edwards Lifesciences’ Sapien 3 and Medtronic’s Evolut R transcatheter aortic valve replacement (TAVR) devices to include patients in all risk categories.” MedPage Today added, “Patients with severe aortic stenosis who are at low surgical risk may now receive TAVR with the balloon-expandable Sapien 3 (regular and Ultra) or the self-expanding Evolut product.” The agency’s “approval follows the ‘game-changing’ PARTNER 3 and Evolut Low Risk trials presented at the American College of Cardiology meeting in 

Informativo

FDA Expands TAVR Devices’ Indications To Severe Aortic Stenosis Patients At Low Surgical R

19/08/2019

FDA Expands TAVR Devices’ Indications To Severe Aortic Stenosis Patients At Low Surgical Risk

MedPage Today (8/16, Lou) reported the FDA “has expanded the indications for Edwards Lifesciences’ Sapien 3 and Medtronic’s Evolut R transcatheter aortic valve replacement (TAVR) devices to include patients in all risk categories.” MedPage Today added, “Patients with severe aortic stenosis who are at low surgical risk may now receive TAVR with the balloon-expandable Sapien 3 (regular and Ultra) or the self-expanding Evolut product.” The agency’s “approval follows the ‘game-changing’ PARTNER 3 and Evolut Low Risk trials presented at the American College of Cardiology meeting in 

Informativo

FDA Expands TAVR Devices’ Indications To Severe Aortic Stenosis Patients At Low Surgical R

19/08/2019

FDA Expands TAVR Devices’ Indications To Severe Aortic Stenosis Patients At Low Surgical Risk

MedPage Today (8/16, Lou) reported the FDA “has expanded the indications for Edwards Lifesciences’ Sapien 3 and Medtronic’s Evolut R transcatheter aortic valve replacement (TAVR) devices to include patients in all risk categories.” MedPage Today added, “Patients with severe aortic stenosis who are at low surgical risk may now receive TAVR with the balloon-expandable Sapien 3 (regular and Ultra) or the self-expanding Evolut product.” The agency’s “approval follows the ‘game-changing’ PARTNER 3 and Evolut Low Risk trials presented at the American College of Cardiology meeting in