REPRISE II Data Support Boston Scientific's Lotus TAVR System

September 15, 2014—Boston Scientific Corporation announced that data from the REPRISE I and REPRISE II clinical trials of the Lotus valve system were presented at the 26^th Transcatheter Cardiovascular Therapeutics scientific symposium in Washington, DC.

The Lotus aortic valve system is a second-generation transcatheter aortic valve replacement (TAVR) technology consisting of a preloaded, stent-mounted tissue valve prosthesis and catheter delivery system for guidance and percutaneous placement of the valve. Lotus continues to demonstrate strong performance as a less invasive treatment for patients with severe aortic stenosis who are considered high risk for surgical valve replacement, advised the company. 

According to Boston Scientific, data from the REPRISE II clinical trial confirmed safety and effectiveness out to 1 year, with more than 86% of patients exhibiting a complete absence of paravalvular aortic regurgitation and no patients demonstrating moderate or severe paravalvular aortic regurgitation. 

REPRISE II is an ongoing prospective, single-arm, multicenter study designed to evaluate safety and performance of the Lotus TAVR system for symptomatic patients with severe calcific aortic stenosis who are considered high risk for surgical valve replacement. The study enrolled 120 patients at 14 sites in Australia, France, Germany, and the United Kingdom.

Key 1-year REPRISE II results include:

•Mean aortic valve pressure gradient remained low and stable at 12.6 + 5.7 mm Hg.

•More than 86% of patients had no paravalvular aortic regurgitation by independent core lab assessment. In addition, no cases of moderate or severe paravalvular aortic regurgitation occurred. Mild and trace paravalvular aortic regurgitation rates were low at 11.4% and 2.3%, respectively.

•Cardiovascular mortality rate was 6.7%.

•Disabling stroke rate was 3.4%.

•No cases of nonstudy valve implantation, unplanned use of cardiopulmonary bypass, valve embolization, valve-in-valve, or ectopic valve placement occurred.

Prof. Ian Meredith, MD, Director of MonashHeart at Monash Medical Centre in Melbourne, Australia, serves as Principal Investigator of the REPRISE II trial.

In the company’s press release, Prof. Meredith stated, “The 1-year REPRISE II data show strong and sustained clinical benefits, excellent valve hemodynamics, and remarkably low rates of paravalvular regurgitation and cardiovascular mortality. These positive data reinforce the benefits and features of the Lotus valve system, including the ability to achieve precise primary valve placement, reposition or fully retrieve if needed, and minimize—if not obliterate—paravalvular regurgitation with an effective Adaptive Seal.”

REPRISE II data build on the positive findings from REPRISE I, a prospective, single-arm feasibility study that evaluated 11 patients. The REPRISE I 2-year results also demonstrated no instances of moderate or severe paravalvular leak and no instances of death. Additionally, patients who received the Lotus valve system had durable and significant improvements in valve area, transvalvular pressure gradients, and New York Heart Association classification compared to baseline.

Boston Scientific noted that the low-profile delivery system and introducer sheath are designed to enable predictable and precise placement associated with early valve function, as well as bidirectional atraumatic repositioning and retrieval at any time before release of the aortic valve implant. The device also features the Adaptive Seal, which is designed to minimize the incidence of paravalvular regurgitation.

In the United States, the Lotus valve system is not available for sale. The device received European CE Mark approval and is available for sale in countries where CE Mark is the regulation in force.