Table 1. Devices for transcatheter aortic valve implantation.
Device and company | Valve structure and size | Valve characteristics | Delivery system and access site | Clinical trials | CE Mark |
First generation transcatheter aortic valves | |||||
CoreValve® (Medtronic) | Porcine pericardium tissue valve Nitinol frame 26, 29, 31 mm |
SEV | TF, TAo and SC | Medtronic CoreValve® US Pivotal trial ADVANCE NOTION |
2007 |
SAPIENTM (Edwards Lifesciences) | Bovine pericardial valve leaflets Stainless steel 23, 26, 29 mm |
BEV | 22 Fr TF, TA and TAo |
The PARTNER I trial | 2007 |
SAPIEN XTTM (Edwards lifesciences) | Bovine pericardial valve leaflets Cobalt chromium frame 20, 23, 26, 29 mm |
BEV Partially repositionable |
18 Fr TF, TA and TAo |
The PARTNER II trial The SOURCE XT trial |
2010 |
New generation transcatheter aortic valves | |||||
Acurate® (Symetis) | Porcine native aortic leaflets Nitinol frame 23, 25, 27 mm |
SEV Not retrievable Repositionable Fast pacing |
Sheatless 28 Fr TA |
ACURATE TA® trial ACURATE Neo and TF® trial |
2011 |
JenaValve® (JenaValve Technology) | Porcine native aortic leaflets Nitinol frame 23, 25, 27 mm |
SEV Retrievable Repositionable Not fast pacing |
Sheatless 32 Fr TA |
JUPITER registry | 2012 for AS 2013 for AR |
Portico®(St Jude) | Porcine pericardium tissue valve Nitinol frame 18, 24 mm |
SEV Retrievable Repositionable Not fast pacing |
18, 24 Fr TF, Tao, TA, SC |
First-in-human experience | 2012 |
DirectFlow® (Direct Flow Medical) | Bovine pericardium tissue valve Polyester cuff 25, 27 mm |
Retrievable Repositionable Not fast pacing |
18 Fr outer diameter TF |
DISCOVER trial DISCOVER registry |
2013 |
Engager® (Medtronic) | Bovine pericardium tissue valve Nitinol frame 23, 26 mm |
SEV Not retrievable Repositionable Fast pacing |
29 Fr TA and TAo |
The Engager® CE pivotal trial | 2013 |
Lotus® (Boston Scientific) | Bovine pericardium tissue valve Nitinol frame 23, 25, 27 mm |
SEV Retrievable Repositionable Not fast pacing |
18, 20 Fr TF |
REPRISE II | 2013 |
SAPIEN 3® (Edwards Lifesciences) | Bovine pericardium tissue valve Cobalt chromium frame 23, 26, 29 mm |
BEV Not retrievable Not repositionable |
14 Fr sheath TF and TA |
The PARTNER II trial The SAPIEN 3 study |
2014 |
Evolut® R (Medtronic) | Porcine pericardium tissue valve Nitinol frame 23, 26, 29, 31 mm |
Recapturable Retrievable Repositionable |
14, 18 Fr sheath TF and SC |
The Medtronic CoreValve® Evolut CE Mark Clinical Trial Study The Medtronic CoreValve® Evolut R U.S. Clinical Study |
2015 |
Centera® (Edwards Lifesciences) | Bovine pericardium tissue valve Nitinol frame with PET skirt 20, 23, 26 mm |
SEV Not retrievable Repositionable |
14 Fr sheath Motorized handle TF and SC |
The ongoing Edwards CENTERA system clinical trial | Under evaluation |
AR: aortic regurgitation; AS: aortic stenosis; BEV: salloon-expandable valve; CE: Conformité Européenne; Fr: French; PET: polyethylene terephthalate; SC: subclavian; SEV: self-expandable valve; TA: transapical; TAo: transaortic; TF: transfemoral.