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| Lotus Valve System--Courtesy of Boston Scientific |
Only 1.1% of patients using the Lotus Valve System TAVI device had moderate paravalvular aortic regurgitation (also referred to as leaking) after 6 months, according to results from the REPRISE II clinical trial released at the EuroPCR conference in Paris, Boston Scientific said in a May 21 statement.
The 30-day mean aortic pressure gradient of 11.5 ± 5.2 mmHg was below the primary endpoint goal of 18 mmHg. Almost 80% of patients had no paravalvular aortic regurgitation and there were no cases of severe regurgitation at 6 months, the statement says. In addition, the all-cause mortality rate was 8.4% and the disabling stroke rate was 3.4%, Boston Scientific said.
According to a study in the journal Cardiovascular Diagnosis & Therapy, mild aortic regurgitation is associated with decreased survival for up to two years after TAVI surgery.
"These new results from the REPRISE II clinical trial program underscore the unique technology behind the Lotus Valve System," said Boston Scientific global chief medical officer Keith Dawkins. "These features are designed to provide a predictable implantation procedure and may result in improved clinical outcomes. The Lotus Valve offers a novel TAVI option for patients with severe aortic valve disease considered at high risk for surgical valve replacement."
The single-arm trial originally concluded in April 2013 consisted of 120 patients in Australia, France, Germany and the United Kingdom, according to clinicaltrials.gov. Boston Scientific says the ongoing trial was then extended to include 130 additional patients.
The Lotus Valve System has a CE mark but is an investigational device in the U.S., meaning it is approved for use in clinical trials only.
- read the release
- get the research article