November 6, 2013 — The Boston Scientific Corp. Lotus Valve System met a performance measure in the treatment of symptomatic patients with severe aortic valve stenosis considered at high risk for surgical valve replacement, according to new data released at the 25th annual Transcatheter Cardiovascular Therapeutics scientific symposium (TCT 2013) in San Francisco.
Data presented as a First Investigation Report by Ian Meredith, director of MonashHeart at Monash Medical Centre in Melbourne, Australia and principal investigator, REPRISE II Trial, demonstrated that the Lotus Valve System, which was implanted successfully in all 120 patients, met the primary device performance endpoint at 30 days with no severe paravalvular aortic regurgitation.
The Lotus Valve System is a differentiated-second generation transcatheter aortic valve replacement (TAVR) device designed for total control. It is both fully repositionable and retrievable prior to release, with a unique Adaptive Seal technology designed to minimize paravalvular aortic regurgitation.
"The results from the REPRISE II trial continue to demonstrate the benefits of the Lotus Valve System, particularly the ability to position the valve accurately the first time, while having the advantage of full retrieval if needed," said Meredith. "In all 120 patients, the Lotus Valve System was successfully implanted and positioned appropriately with negligible aortic regurgitation while reporting low 30-day all-cause mortality and major stroke rates in this sick patient population."
REPRISE II is an ongoing prospective, single-arm study that has enrolled 120 patients at 14 sites in Australia, France, Germany and the United Kingdom. REPRISE II is being extended to enroll an additional 130 patients at 20 sites in Australia and Europe.
Key findings included:
- The primary device performance endpoint assessed by an independent core lab was met as the 30-day mean aortic valve pressure gradient of 11.5±5.2 mmHg was significantly (p < 0.001) less than the performance goal of 18 mmHg.
- The primary safety endpoint, defined as all-cause mortality at 30 days, was 4.2 percent.
- Independent core lab assessment of paravalvular aortic regurgitation at 30 days indicated no severe regurgitation and one case of moderate regurgitation (1 percent). In 5.2 percent of patients regurgitation was considered trace and in 78.4 percent of patients, there was no paravalvular regurgitation at 30 days.
- No instances of non-study valve implantation, unplanned use of cardiopulmonary bypass, valve embolization, valve-in-valve or ectopic valve placement occurred.
- The disabling stroke rate for the 120 patients at 30 days was 1.7 percent. The total stroke rate, disabling and non-disabling combined, was 5.9 percent, which is the same rate as the Edward's Sapien valve's performance in the PARTNER trial.
One-year results from REPRISE I were presented in May at EuroPCR by Meredith and published online ahead of print by EuroIntervention. The data demonstrated sustained safety and performance of the Lotus Valve out to one year with no new major adjudicated events, as defined by the Valve Academic Research Consortium (VARC), and no moderate or severe paravalvular aortic regurgitation in any patient.
"These new results from the REPRISE clinical trial program, and particularly those from the REPRISE II trial, underscore the unique technology behind the Lotus Valve System," said Keith Dawkins, M.D., global chief medical officer, Boston Scientific. "These features lead to a predictable implantation procedure and may result in improved clinical outcomes. The Lotus Valve offers a novel TAVR option for patients with severe aortic valve disease considered at high risk for surgical valve replacement."
About the Lotus Aortic Valve System
?The Lotus Aortic Valve System is a differentiated second-generation TAVR technology, consisting of a pre-loaded, stent-mounted tissue valve prosthesis and catheter delivery system for guidance and percutaneous placement of the valve. The low-profile delivery system and introducer sheath are designed to enable predictable and precise placement associated with early valve function, as well as bi-directional atraumatic repositioning and retrieval at any time prior to release of the aortic valve implant.
The Lotus Valve System has CE mark approval and is available for sale in Europe and CE mark countries. In the United States, the Lotus Valve System is an investigational device and not available for sale.
For more information: www.bostonscientific.com