LOTUS Edge

Aortic Valve System

Surgical-Like PVL

Designed to help physicians achieve surgical-like paravalvular leak (PVL) rates, the LOTUS Edge Aortic Valve System demonstrates best-in-class PVL across studies.
LOTUS Edge PVL features
Adaptive SealTM Technology: A unique multi-layer, multi-polymer seal creates a secure seal against the annulus, virtually eliminating PVL.

Braided Nitinol Frame: Designed for strength, flexibility and repositionability, the braided nitinol frame conforms to irregular patient anatomies to help prevent PVL.

REPRISE III: 1-Year PVL Rates1

87.6% None/Trace PVL

None/Trace PVL

11.5% Mild PVL

Mild PVL

0.9% Moderate or Greater PVL

Moderate or Greater PVL

1. Feldman TE, et al. JAMA 018;319:27–37.
 

PVL Rates Across Studies

The LOTUS™ Valve has consistently demonstrated surgical-like paravalvular leak rates in clinical studies. The latest data presented on LOTUS Edge show a 97.1% rate of none/trace PVL at one year.
PVL Rates Across Studies
1. Van Mieghem et al. JACC: Cardiovascular Interventions. 2019.
2. Walters D., MD. First Report of Clinical Outcomes with the Next-Generation LOTUS Edge Valve System: Results from the LOTUS Edge Feasibility Trial; ACC 2017; Washington, DC.
3. Meredith et al. Repositionable percutaneous aortic valve implantation with the LOTUS valve: 30-day and 1-year outcomes in 250 high risksurgical patients. Eurointervention. 2017. 13 (7): 788-795..
4. Van Mieghem et al. Use of a Repositionable and Fully Retrievable Aortic Valve in Routine Clinical Practice: The RESPOND Study and RESPOND Extension Cohort. JACC: Cardiovascular Interventions. 2019. 14;12(1):38-49.
5. Feldman T., MD, Reardon M., MD, Rajagopal V., MD, et al. Effect of mechanically expanded vs self-expanding transcatheter aortic valve replacement on mortality and major adverse clinical events in high-risk patients with aortic stenosis - the REPRISE III randomized clinical trial. JAMA. 2018;319(1):27-37.
6. Götberg M., MD. One-year outcomes with the transcatheter LOTUS Edge Aortic Valve System; PCRLV 2018; London, United Kingdom.
 

Significantly Lower PVL Rates

Compared to Evolut™ R/CoreValve™, the LOTUS Valve platform demonstrated significantly lower paravalvular leak rates at 30 days and 1 year in REPRISE III.

≥ Mild PVL at 30 Days

P < 0.0001*

 ≥ Mild PVL at 30 Days - 10.7% LOTUS Valve vs. 58.3% Evolut R/CoreValve

≥ Moderate PVL at 1 Year

P < 0.0001

 ≥ Moderate PVL at 1 Year 0.9% LOTUS Valve vs. 6.9% Evolut R/CoreValve

* Includes comparison of number of patients with mild PVL [P < 0.0001] and patients with moderate or greater PVL [P < 0.0001] treated with LOTUS vs. Evolut R/CoreValve.

Asch F, Mani V, Singh A, et al. Hemodynamic and Echocardiographic Comparison of the Lotus and CoreValve Transcatheter Aortic Valves in Patients With High and Extreme Surgical Risk: An Analysis From the REPRISE III Randomized Controlled Trial. CIRCULATIONAHA.2018;118.034129, originally published March 12, 2018.

 

PVL in Patients with High Calcium Burden

In the REPRISE III Clinical Trial, the LOTUS Valve platform had significantly lower paravalvular leak rates in patients with high calcium burden than Evolut R/CoreValve. This data is consistent with the superior PVL performance of LOTUS in the broader REPRISE III Trial.
REPRISE III: High Calcium Cohort
Makkar R., MD. The impact of calcium burden on clinical outcomes and paravalvular regurgitation in the REPRISE III randomised controlled clinical trial; PCRLV 2017; London, United Kingdom.
 

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
Clinical Outcomes

Clinical Outcomes

Explore the clinical data showing superior paravalvular leak, stroke and procedural outcomes for the LOTUS Edge Aortic Valve System.

Button
Top