Boston Scientific Corporation (BSX) has launched the RESPOND Post Market Registry to evaluate the real world performance of the Lotus Valve System – a differentiated second generation transcatheter aortic valve implantation (:TAVI) technology.
Following the news, Boston Scientific's share price gained 1.1% to eventually close at $13.18 yesterday.
The RESPOND Registry will accumulate data on clinical outcomes and device performance from 1,000 patients who have been implanted with the aforementioned valve at 50 centers around the world.
So far, 3 patients enrolled in the RESPOND Registry have been successfully implanted with the Lotus Valve System. This particular valve system simplifies the TAVI procedure with its ability to estimate valve functionality fully before release, thereby ensuring optimal valve implantation.
The first TAVI procedure at Erasmus Medical Center in Rotterdam, the Netherlands was conducted by two physicians, Dr. Nicolas Van Mieghem and Prof. Peter De Jaegere, using the Boston Scientific Safari Pre-Shaped TAVI Guidewire. The Safari Guidewire, compatible with the Lotus Valve System and other TAVI devices, has received the U.S Food and Drug Administration (:FDA) clearance and CE Mark in 2013 and is designed to provide stable, atraumatic valve placement.
The RESPOND Registry is a prospective, open label, single arm, multi-center, observational post market study. Clinical follow-up is at discharge, 30 days, 12 months and annually through five years.
The RESPOND Registry will entail analysis of the echocardiographic images collected from the patients by an independent core laboratory, and examination of key clinical events by an independent clinical events committee. Such measures are aimed at improving the quality of the collected data and addressing inconsistencies that are usually noticed in case of site-reported data in post market studies.
The Lotus Valve System offers a unique precise valve placement treatment for patients with severe aortic stenosis at high risk of surgery. It allows for implantation without the need for temporary pacing at the time of deployment.
Its unique features include an Adaptive Seal that minimizes paravalvular leakage. This has already been confirmed in the results of the REPRISE clinical program.
The 6-month clinical study outcomes of REPRISE II, presented at EuroPCR 2014 in Paris, validated that only 1.1% of patients implanted with the Lotus valve system are having moderate paravalvular aortic regurgitation (leaking). At present, REPRISE II is evaluating the Lotus Valve System in symptomatic high-risk surgery patients with severe aortic valve stenosis.
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