Mass./PRNewswire/ — Boston Scientific Corporation announces
results from the REPRISE I feasibility trial, which evaluated the acute safety
of the Lotus™ Aortic Valve System in patients with severe aortic valve disease.
The Lotus Aortic Valve System is the first transcatheter aortic valve
replacement (TAVR) device of its kind that is designed to minimize aortic
regurgitation (leaking) and is both fully repositionable and retrievable prior
to release. Data presented today at the annual EuroPCR Scientific Program
demonstrated successful deployment of the valve in all patients with virtually
no paravalvular regurgitation after valve placement or at discharge.
“Perhaps the most impressive feature of the Lotus Valve
System in this study was the ability to precisely position the valve on the
first attempt, eliminating the need for repositioning, although this capability
was available if needed,” said Ian Meredith, Professor and Director of
MonashHeart, at Monash Medical Centre in Melbourne, Australia, and principal
investigator of the REPRISE I Trial. “Another striking feature was
that the valve operated early in the deployment process, providing us some
comfort and time to consider the valve position, as well as the immediate and
almost complete obliteration of aortic regurgitation even in patients who had
moderately severe aortic regurgitation after balloon valvuloplasty. In
this regard, I think the Lotus valve technology is somewhat unique.”
REPRISE I is a prospective, single-arm feasibility study
that enrolled 11 patients at three sites in Australia. The primary endpoint is
defined as successful device implantation without in-hospital major adverse
cardiovascular or cerebrovascular events (MACCE) through discharge or seven
days post-procedure (whichever comes first). In-hospital MACCE includes
death, heart attack, major stroke, and conversion to surgery or repeat
procedure due to valve-related dysfunction. All patients had severe
symptomatic aortic stenosis and were considered at high risk for surgical valve
replacement. No in-hospital MACCE were reported in 91 percent (10 of the
11) of patients. One stroke and no deaths were observed. No
moderate or severe paravalvular regurgitation was present after valve placement
or at discharge.
The Lotus Aortic Valve System is a differentiated
second-generation TAVR technology, which consists 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,
as well as bi-directional atraumatic repositioning and retrieval at any time
prior to release of the aortic valve implant. The device also employs a
unique Adaptive Seal™ feature designed to minimize the incidence of
paravalvular regurgitation, which has proven to be a predictor of mortality.
“The REPRISE I results underscore the unique technology
behind the Lotus Aortic Valve System, which offers interventional cardiologists
greater precision and control in deployment while at the same time minimizing
the occurrence of aortic regurgitation. These features help to simplify the
implantation procedure, and will potentially lead to improved clinical
outcomes,” said Keith D. Dawkins, M.D., global chief medical officer for
Boston Scientific. “We look forward to advancing the Lotus Aortic Valve
System clinical program by initiating patient enrollment in the REPRISE II
study later this year.”
The REPRISE II trial is designed to evaluate the safety and
performance of the Lotus Aortic Valve System in 120 patients at up to 15 sites
in Australia and Europe. Data from the trial are expected to be used
to support CE Mark and other international regulatory approvals.
Enrollment is expected to be completed in the first half of 2013.
The Lotus Aortic Valve System™ is an investigational device,
limited by applicable law to investigational use and not available for
sale. The device was developed by Sadra Medical, which Boston Scientific
acquired in 2011. For more information, visit www.sadramedical.com.
About Aortic Valve Disease
Aortic valve disease results in dysfunction of the aortic valve, one of the
four valves that control the flow of blood in and out of the heart.
Aortic valve stenosis is the process of thickening and stiffening in the valve,
which can result in an abnormal narrowing of the aortic valve opening and
reduction in blood flow. Aortic stenosis is a common problem affecting
approximately 3 percent of the population over age 65 and 5 percent of people
older than 75. From the onset of aortic stenosis symptoms, the average
survival rate is 50 percent at two years and 20 percent at five years.
Boston Scientific is a worldwide developer, manufacturer and marketer of
medical devices that are used in a broad range of interventional medical
specialties. For more information, please visit: www.bostonscientific.com.