HEALTHTECH PROGRAMME

ACURATE neo2 is a self-expanding transcatheter heart valve made from porcine pericardial tissue. It is positioned supra-annularly and is available in 3 sizes: 23 mm, 25 mm and 27 mm. It is indicated for relief of aortic stenosis in people with symptomatic heart disease due to severe native calcific aortic stenosis when a heart team, including a cardiac surgeon, decides that a transcatheter heart valve replacement is appropriate.

Allegra is a self-expanding transcatheter heart valve made from bovine pericardial tissue. It is positioned supra-annularly and is available in 3 sizes: 23 mm, 27 mm and 31 mm. It is indicated for treating severe calcified aortic valve stenosis in people at high surgical risk and for treating severe calcified aortic valve stenosis in people with a symptomatic degeneration of an aortic valve bioprosthesis.

Evolut R, Evolut Pro+ and Evolut FX are self-expanding transcatheter heart valves made from porcine pericardial tissue. They are positioned supra-annularly and are available in 4 sizes: 23 mm, 26 mm, 29 mm and 34 mm. The valves are indicated for adults presenting with severe native aortic valve stenosis. In severe native bicuspid aortic valve stenosis, the Evolut transcatheter heart valves are indicated for people at intermediate or greater risk for surgical aortic valve replacement (SAVR), or a documented heart team agreement of risk for SAVR because of frailty or comorbidities. Intermediate risk is defined as the Society of Thoracic Surgeons (STS) operative risk score of 4% and above. For people presenting at low risk for SAVR (less than 4%), the systems are indicated for people aged 70 and older with a left ventricular ejection fraction (LVEF) above 30%. Evolut R, Evolut Pro+ and Evolut FX are also indicated for people with a stenosed, insufficient, or combined surgical bioprosthetic valve failure needing valve replacement who are at high or greater risk for SAVR, or there is a documented heart team agreement of risk for SAVR because of frailty or comorbidities. High risk is defined as STS operative risk score of 8% and above. Compared with the Evolut R, the Evolut Pro+ has an additional external pericardial wrap and an updated delivery system. Compared with the Evolut Pro+, the Evolut FX has additional gold markers to visualise implant depth and coronary alignment, and has an updated delivery system.

Hydra is a self-expanding transcatheter heart valve made from bovine pericardial tissue. It is positioned supra-annularly and is available in 3 sizes: 22 mm, 26 mm and 30 mm. It is indicated for people with severe degenerative aortic stenosis presenting with a high predictable operative mortality risk for surgical aortic valve replacement. The decision is based on the clinical judgment of the heart team.

Myval Octacor is a balloon-expanding transcatheter heart valve made from bovine pericardial tissue. It is positioned intra-annularly and is available in 9 sizes between 20 mm and 32 mm. Myval Octacor is indicated for relief of aortic stenosis in people with symptomatic heart disease because of severe native calcific aortic stenosis as judged by a heart team, including a cardiac surgeon. It is also indicated for people who have a risk for open heart surgery (STS operative risk score of 4% and above risk of mortality at 30 days).

Navitor is a self-expanding transcatheter heart valve made from bovine pericardial tissue. It is the only self-expanding valve with intra-annular leaflets. Navitor is available in 4 sizes: 23 mm, 25 mm, 27 mm and 29 mm. Navitor is indicated for people with symptomatic severe native aortic stenosis who are considered high or extreme risk for SAVR.

Sapien 3 and Sapien 3 Ultra are balloon-expanding transcatheter heart valves made from bovine pericardial tissue. They are positioned intra-annularly and are available in 20 mm, 23 mm and 26 mm sizes. Sapien 3 is also available in a 29 mm size. The valves are indicated for people with severe, symptomatic, calcific aortic valve stenosis who a heart team considers to be at intermediate or greater risk for open heart surgery. Intermediate or greater risk is defined as a predicted risk of surgical mortality of 3% and above at 30 days, based on the STS risk score and other clinical comorbidities unmeasured by the STS risk calculator. The valves are also indicated for people with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic valve or a surgical bioprosthetic mitral valve who a heart team, including a cardiac surgeon, considers to be at high or greater risk for open surgical therapy. High or greater risk is defined as a predicted risk of surgical mortality of 8% and above at 30 days, based on the STS risk score and other clinical comorbidities unmeasured by the STS risk calculator. Compared with the Sapien 3, the Sapien 3 Ultra has an augmented outer skirt.

Trilogy is a self-expanding transcatheter heart valve made from porcine pericardial tissue. It is positioned supra-annularly and is available in 3 sizes: 23 mm, 25 mm and 27 mm. Trilogy is indicated for people with native symptomatic, severe aortic regurgitation or symptomatic, severe aortic stenosis who a heart team, including a cardiac surgeon, considers to have high or greater risk for SAVR. High or greater risk is defined as a predicted risk of surgical mortality of 8% and above at 30 days, based on the STS risk score and other clinical comorbidities unmeasured by the STS risk calculator.