Boston Scientific has launched a postmarket registry to assess real-world performance of its Lotus second-generation transcatheter aortic valve implantation System, the Natick, Mass.-based company said Wednesday.

The RESPOND Post Market Registry will collect data on clinical outcomes and device performance in 1,000 patients implanted at 50 medical centers around the world, according to the company. To date, three patients enrolled in the registry have been implanted with the Lotus Valve System.
Follow-up will occur when the patient is discharged, and again at 30 days, 12 months and annually through five years, Boston Scientific says.

The prospective, open-label, multicenter, single-arm, observational postmarket study has a primary endpoint of all-cause mortality compared with a performance goal, plus undisclosed secondary endpoints using Valve Academic Research Consortium guidelines and definitions, the devicemaker says.

An independent lab will analyze the echocardiographic images, and an independent clinical events committee will judge key clinical events — measures designed to increase the quality of data and address inconsistencies with site-reported data, factors that are frequently seen in other postmarket studies, the company notes.

The Lotus system is indicated for patients with severe aortic stenosis who are at high risk for surgical valve replacement. 

The system received CE Mark approval on last October and is available for sale in countries that observe that designation. It remains investigational in the U.S. — Kellen Owings

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