LOTUS Edge

Aortic Valve System

LOTUS Edge Study*

Designed to evaluate the safety and performance of the LOTUS Edge Aortic Valve System in high-surgical-risk patients with symptomatic calcific aortic stenosis, the LOTUS Edge Study combines results from two single-arm studies with similar protocols and identical core labs.
97.1% None/Trace PVL at 1 Year

None/Trace PVL at 1 Year

* Götberg M., MD. One-year outcomes with the transcatheter LOTUS Edge Aortic Valve System; PCRLV 2018; London, United Kingdom.

Study Design

LOTUS Edge Feasibility Study
21 high-surgical-risk patients with symptomatic calcific aortic stenosis enrolled at 2 centers in Australia
 

REPRISE Edge
15 high-surgical-risk patients with symptomatic calcific aortic stenosis enrolled at 3 centers in Europe
 

LOTUS Edge Combined Cohort (N = 36)

  • 1-Year Clinical Follow-Up Available: 97.2% (35/36)
    (1 patient missed the 1-year visit in REPRISE Edge)
  • 1-Year TTE Assessment Performed: 34

Baseline Characteristics

Characteristic LOTUS Edge Feasibility Study (N = 21) REPRISE Edge
(N = 15)
Combined Cohort
(N = 36)

Female

61.9%

66.7%

63.9%

Age, years

84.0 ± 5.1

83.2 ± 6.1

83.7 ± 5.4

STS Score, %

4.3 ± 1.5

4.5 ± 2.5

4.4 ± 1.9

EuroSCORE 2011, %

4.1 ± 3.3

5.4 ± 3.8

4.7 ± 3.6

History of stroke, %

4.8%

13.3%

8.3%

NYHA Functional Class III or IV

57.1%

66.7%

61.1%

Mean aortic valve area, cm2*

0.63 ± 0.19

0.64 ± 0.19

0.63 ± 0.19

Mean aortic valve gradient, mmHg*

51.3 ± 9.5

49.5 ± 16.0

50.6 ± 12.2

Calcification, moderate/severe, %*

85.7%

100%

91.2%

Left ventricular ejection fraction, %*

57.5 ± 7.6 (21)

59.1 ± 4.5 (10)

 58.0 ± 6.7 (31)

Permanent pacemaker at baseline

14.3% (3/21)

0% (0/15)

8.3% (3/36)

All patients had agreement by the Heart Team that they were at high risk for surgery based on STS Score and/or comorbidities.
* As assessed by an independent core laboratory.  

1-Year Clinical Outcomes (N = 36)

97.1% None/Trace PVL

None/Trace PVL

0% All-Cause Death

0% All-Cause Death

0% Cardiovascular Death

0% Cardiovascular Death

Event

% Patients

All-Cause Death

0%

Cardiovascular Death

0%

All Stroke

5.6% (n = 2)

Disabling Stroke

5.6% (n = 2)

Repeat Procedure

0%

Valve or CHF Related Hospitalization

5.6% (n = 2)

New Permanent Pacemaker Implantation

15.2% (n = 5)

† Rate excludes patients with permanent pacemaker at baseline (n = 3).

Surgical-Like PVL

The LOTUS Edge Aortic Valve System demonstrates surgical-like paravalvular leak (PVL) rates, with the latest clinical data showing a 97.1% rate of none/trace PVL at one year.

PVL Through 1 Year

PVL Through 1 Year
Among patients with evaluable echocardiograms. As assessed by an independent core laboratory.  

Surgical-Like PVL

Surgical-Like PVL

Learn how our unique Adaptive Seal™ and braided valve frame conform to each patient’s anatomy, virtually eliminating paravalvular leak.

Button
Stable Delivery

Stable Delivery

Discover how our exclusive deployment technology was designed to provide complete control, precise placement and stable deployment.

Button
100% Repositionable

100% Repositionable

Find out how LOTUS Edge enables you to assess final valve position after 100% deployment with the option to recapture and reposition.

Button
Top