Boston Scientific Initiates RESPOND Postmarket Registry of Lotus TAVR System

June 4, 2014—Boston Scientific Corporation announced that it has initiated the RESPOND postmarket registry to assess real-world performance of the Lotus valve system in transcatheter aortic valve replacement (TAVR) procedures. The RESPOND registry will collect data on clinical outcomes and device performance in 1,000 patients implanted at 50 centers around the world.

In October 2013, the company announced that the Lotus valve system received European CE Mark approval. In the United States, the Lotus device is an investigational device and is not available for sale.

According to Boston Scientific, three patients enrolled in the RESPOND registry have been successfully implanted with the Lotus valve system. Nicolas Van Mieghem, MD, and Prof. Peter De Jaegere, MD, led the registry’s first TAVR procedure at Erasmus Medical Center in Rotterdam, the Netherlands. The investigators used Boston Scientific’s Safari preshaped TAVR guidewire, which is designed to facilitate stable, atraumatic valve placement and is compatible with the Lotus valve system and other TAVR devices. The Safari guidewire received US Food and Drug Administration clearance and CE Mark approval in 2013.

In Boston Scientific’s press release, Dr. Van Mieghem, who is the postmarket study’s Co-Lead Principal Investigator, commented, “It's a great privilege to kick off the RESPOND registry with this first implant. The Lotus valve system truly is an elegant and novel transcatheter valve concept providing a high level of precision and control. It simplifies the TAVR procedure by having the ability to assess valve functionality fully before release, which helps ensure optimal valve placement and a positive clinical outcome.”

Boston Scientific advised that the RESPOND registry is a prospective, open-label, single-arm, multicenter, observational postmarket study. Clinical follow-up is at discharge, 30 days, 12 months, and annually through 5 years. The registry’s primary endpoint is all-cause mortality compared to a performance goal. Secondary endpoints use Valve Academic Research Consortium guidelines and definitions. An independent core laboratory will analyze the echocardiographic images, and an independent clinical events committee will adjudicate key clinical events. These measures are designed to increase the quality of the collected data and address inconsistencies with site-reported data commonly observed in postmarket studies, noted the company.

The Lotus valve system is a next-generation TAVR device designed to provide an effective treatment for patients with severe aortic stenosis at high risk for surgical valve replacement. The REPRISE II trial is evaluating the Lotus valve system in symptomatic patients with severe aortic valve stenosis considered high risk for surgical valve replacement. 

Boston Scientific noted that 6-month data from the REPRISE II clinical study were presented in May at the EuroPCR 2014 conference in Paris, France. The data demonstrated that the Lotus device delivered sustained safety and effectiveness outcomes out to 6 months, with only 1.1% of patients having moderate paravalvular aortic regurgitation and with no severe cases.