Feature | Heart Valve Technology | May 25, 2017

Lotus TAVR System Shows Superior Efficacy to CoreValve in Global REPRISE III Trial

One-year data show Lotus is superior to CoreValve in stroke, death and paravalvular leak
 

The Boston Scientific Lotus TAVR Valve

May 25, 2017 — Positive results from the REPRISE III clinical trial, presented at the annual EuroPCR Scientific Program, in Paris, demonstrated that the Boston Scientific Lotus Valve System, a transcatheter aortic valve implantation (TAVI) system, showed superiority over the Medtronic CoreValve TAVR System platform for the primary effectiveness endpoint and non-inferiority for the primary safety endpoint.

The REPRISE III clinical trial data will be used to support U.S. Food and Drug Administration (FDA) premarket approval for the Lotus Valve.

The primary effectiveness endpoint, a composite of all death, disabling stroke and moderate or greater paravalvular aortic leakage (PVL) at one year, was lower with the Lotus compared to the CoreValve platform (16.7 vs. 29%, p<0.001). The Lotus also demonstrated non-inferiority to CoreValve platform for the primary safety endpoint which was a composite of all-cause mortality, stroke, life-threatening and major bleeding events, stage two or three acute kidney injury or major vascular complications through 30 days.

The pre-specified secondary endpoint demonstrated the Lotus Valve system had significantly lower rates of moderate to severe PVL occurrences when compared to the CoreValve platform (2 vs. 11.1%, p<0.001).

“The excellent results seen in this large randomized trial, particularly the superior performance in efficacy and the continued demonstration of low PVL rates, further establish the advantages of the Lotus Valve system,” said Ted E. Feldman, M.D., director, cardiac catheterization laboratory, NorthShore University HealthSystem in Evanston, Illinois, and co-investigator of the REPRISE III trial. “With the Lotus Valve system, I have confidence that I can position the valve accurately in every case and achieve good outcomes for my patients.”

REPRISE III is the first head-to-head pivotal study comparing two different TAVI platforms: the Lotus Valve system and the CoreValve platform, including both CoreValve and EvolutR. It is a multi-center, randomized controlled trial that included 912 patients from the United States, Europe, Canada and Australia with severe aortic stenosis who were considered to be at high or extreme risk for surgical valve replacement.

“We are very excited by the performance of the Lotus Valve system in this trial as it represents a crucial piece of clinical evidence for the Lotus platform,” said Ian Meredith, M.D., executive vice president and global chief medical officer, Boston Scientific. “We believe that these data, along with upcoming findings to be shared from the RESPOND and RESPOND Extension studies, can further illustrate the unique clinical benefits that this system offers physicians for the treatment of patients.”

 

Related Content on the Lotus TAVR Valve System

REPRISE II Data Show Sustained Performance At One Year For Boston Scientific Lotus Valve System

Boston Scientific Lotus Valve System Demonstrates Extremely Low PVL Rates

Advances and Future Directions for Transcatheter Valves

Boston Scientific Gains European Approval for Next Generation Lotus Edge TAVR System

Boston Scientific Enrolls First Patients in U.S. Trial of Lotus Valve System

 

The Lotus Valve System is not available for sale in the United States.

For more information: www.bostonscientific.com

Related Content

Videos | Cath Lab| January 04, 2018
Bernadette Speiser, BSN, MSN, CCRN, RCIS, a cardiac cath/EP nurse at Palo Alto Veterans Hospital, Palo Alto, Calif.,
FDA Initiates Class I Recall of Sterilmed Reprocessed Agilis Steerable Introducer Sheath
News | Cath Lab| January 04, 2018
The U.S. Food and Drug Administration (FDA) announced a Class I recall of Sterilmed’s Agilis Steerable Introducer...
The California Heart & Vascular Clinic in El Centro, Calif., treated the first post-FDA clearance patient with a DABRA atherectomy system. Athar Ansari, M.D.

The California Heart & Vascular Clinic in El Centro, Calif., treated the first post-FDA clearance patient with a DABRA system. 

Feature | Cath Lab| November 24, 2017 | Athar Ansari, M.D., FACC
As debates about the current state and future of healthcare rage in Congress, the media and healthcare settings acros
Videos | Cath Lab| November 08, 2017
Juan Granada, M.D., Cardiovascular Research Foundation president and chief executive officer, shares his insights on
Results of the ORBITA study found no difference in exercise time after six weeks in patients with stable angina who received percutaneous coronary intervention (PCI) versus a placebo treatment. TCT 2017
Feature | Cath Lab| November 06, 2017
November 6, 2017 – Results from ORBITA, a prospective multi-center randomized blinded placebo-controlled study, found
Culprit Lesion-Only PCI Improves Outcomes for Cardiogenic Shock Patients Compared to Multivessel PCI
News | Cath Lab| November 01, 2017
November 1, 2017 — Results from the prospective, randomized, multicenter CULPRIT-SHOCK trial found an initial strateg
Three-Year Quality of Life Improvements Similar for PCI and CABG in Left Main Disease
News | Cath Lab| October 30, 2017
October 30, 2017 — New study results from the EXCEL trial comparing the quality of life (QoL) of patients with left m
Corindus Evaluates Incorporating HeartFlow Technology With CorPath GRX System
Technology | Cath Lab| October 26, 2017
Corindus Vascular Robotics Inc. announced that it will incorporate the HeartFlow FFRct (fractional flow reserve-...
Shockwave Medical Announces $35 Million in New Financing
News | Cath Lab| October 24, 2017
October 24, 2017 — Shockwave Medical reported $35 million in new financing, an extension of the company’s previously
Overlay Init