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FDA Panel OKs Expanded Indication for TAVR Device
The FDA’s Circulatory System Devices Panel has recommended to expand the indication for the Sapien transcatheter heart valve to include patients who are eligible, but at high risk, for surgical aortic valve replacement, voting 11-0, with one abstention, that the benefits outweigh the risks.
The panel also voted on two other questions during the meeting, including whether there was reasonable assurance that the Sapien valve (model 9000TFX, sizes 23 mm and 26 mm; Edwards Lifesciences) is safe for use in patients who meet the criteria specified in the proposed indication (10 yes, 2 no) and whether there is reasonable assurance that the valve is effective for use in patients who meet the criteria specified in the proposed indication (12 yes, 0 no).
All three votes covered transfemoral and transapical access approaches.
For the transfemoral approach, the indication encompasses patients with severe symptomatic native aortic valve stenosis who have been examined by a heart team, which includes a cardiac surgeon. Additionally, the indication includes inoperable patients in whom existing comorbidities would not preclude the expected benefit, as well as operable candidates for aortic valve replacement with a high (=15%) risk of mortality for surgical AVR.
For the transapical approach, patients must have severe symptomatic native aortic valve stenosis and have been examined by a heart team that includes a cardiac surgeon and found to be an operative candidate with a high (=15%) risk of mortality for surgical AVR.