Marking a major step forward in
the evolution of Transcatheter Aortic Valve Implantation (TAVI) technology,
the first two commercial implants of the Boston Scientific BSX Lotus™
Valve System have taken place in a German hospital. Prof. Dr. med. Gerhard
Schuler and Prof. Dr. med. Axel Linke, both considered TAVI pioneers, led the
procedures at the Heart Center - University Hospital Leipzig, Germany. CE
Mark approval for the Lotus Valve System was announced October 28, 2013 at the
Transcatheter Cardiovascular Therapeutics (TCT) Conference in San Francisco.
The Lotus Valve System offers a unique and effective alternative treatment for
patients with severe aortic stenosis at high risk of surgical valve
replacement. It is a next-generation transcatheter aortic valve implantation
(TAVI) device designed to give physicians total control throughout the TAVI
procedure. The Lotus Valve is comprised of bovine pericardium and a nitinol
frame with a central marker to aid in precise positioning. It features a
novel Adaptive Seal™ technology to help minimize aortic regurgitation
(leaking), a proven predictor of mortality. It is also the first device of
its kind that can be fully retrieved, redeployed, or repositioned, including
after full valve deployment and prior to release.
"The Lotus Valve System permits very precise positioning of the device and the
Adaptive Seal minimizes potential paravalvular leakage," said Professor
Schuler. "These are the key differentiating features of this new technology."
Primary endpoint data from the REPRISE II clinical trial were presented at TCT
by Prof. Ian Meredith, principal investigator and director of MonashHeart at
Monash Medical Centre, Melbourne, Australia. The data demonstrated that the
Lotus Valve System was successfully implanted and correctly positioned in all
120 patients, and met the co-primary endpoints of mean aortic valve pressure
gradient and all-cause mortality at 30 days. The valve produced impressive
clinical results, with no valve malpositioning, migration, or severe
embolization, low clinical event rates that were consistent with those
reported for other valves, and negligible paravalvular aortic regurgitation at
30 days.
The Lotus Valve System comes pre-attached on a transfemoral delivery system
and is inserted into the body through a small incision in the leg. Once
delivered across the diseased aortic valve, the Lotus Valve System is deployed
through a controlled mechanical expansion that is distinct from
balloon-expandable or self-expanding valves.
"The controlled mechanical expansion and early functioning of the valve
facilitate precise positioning on the first attempt, and the ability to fully
or partially recapture the valve, if necessary, provides additional assurance
that the valve will be ideally positioned at the end of the procedure," said
Dr. Linke.
The Lotus Valve System is available at select centers in Europe with
commercial site expansion accelerating as physicians and centers become fully
trained. The valve is available in a 23mm and 27mm size, treating patients
with aortic annulus sizes from 20mm to 27mm. The Lotus Valve System is an
investigational device in the United States and Japan and is not available for
sale in these countries.
"Completing our first commercial implants marks a key step forward in offering
an advanced new technology in Europe. The Lotus Valve System has been
designed to give the physician increased control during implantation and to
help provide a more precise, predictable procedure," said Tom Fleming, vice
president and general manager, Structural Heart, Boston Scientific. "We
believe the Lotus Valve is an important treatment alternative for severe
aortic valve disease patients at high risk for surgical valve replacement."
To view and download an image of the Lotus Valve System, click here.
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