MARLBOROUGH, Mass.,
May 20, 2015 /PRNewswire/ -- A new
study evaluating the Boston Scientific (NYSE: BSX) Lotus™ Valve
System demonstrated an extremely low rate of paravalvular aortic
regurgitation (leakage) for a transcatheter aortic replacement
valve, plus a cardiovascular mortality rate of less than two
percent at 30 days.
Thirty day results for the first 250 patients in the RESPOND
Post-Market Study were presented at EuroPCR 2015 in Paris by Nicolas M.
Van Mieghem, M.D., co-principal investigator, Erasmus
Medical Center in Rotterdam, the
Netherlands. Key findings include the following:
- more than 95 percent of patients at hospital discharge had no
or trace paravalvular aortic regurgitation (PVL), less than 5
percent had mild PVL and no patients exhibited moderate or severe
PVL (as assessed by an independent core lab);
- the cardiovascular mortality rate was 1.6 percent at 30 days;
and
- the mean pressure gradient and effective orifice area (EOA),
measures used to assess the hemodynamic performance of the valve,
were 10.1 +/- 3.7 mmHg and 1.9 cm2 +/- 0.4
(both p<0.001 vs. baseline).
"These first post-market study data from the RESPOND trial
demonstrate that the Lotus Valve System can be used in clinical
practice with an excellent safety profile and unprecedented low PVL
rates," said Dr. Van Mieghem.
"The absence of PVL is associated with favorable long-term
survival."
In addition, rates and predictors for PVL were reported today
from the REPRISE II Extended Cohort by Daniel Blackman, M.D., Leeds General Infirmary,
Leeds, England. Key findings
in the trial, involving 250 patients evaluated at 30 days post
implantation, include the following:
- nearly 86 percent of patients had either no PVL or trace PVL;
less than 14 percent had mild PVL and less than 1 percent had
moderate PVL (as assessed by an independent core lab);
- no patients had severe PVL; and
- significant independent predictors of PVL included device:
annulus area ratio and calcium volume.
Strong performance results from both studies continue to
reinforce this therapy as a less invasive treatment alternative for
patients with severe aortic valve stenosis who are considered to be
at high risk for surgical valve replacement.
"These results are further evidence that the Lotus valve design,
its precise placement and redeployment capabilities and its low
rates of paravalvular regurgitation can make a significant and
meaningful difference in the lives of patients," said Keith D. Dawkins, M.D., global chief medical
officer, Boston Scientific.
About the Lotus Valve System
The Lotus Valve System is a differentiated next-generation
transcatheter aortic valve implantation (TAVI) device, consisting
of a pre-attached, stent-mounted tissue valve prosthesis and
catheter delivery system for guidance and percutaneous placement of
the valve. It is the first device of its kind that offers
controlled mechanical expansion, which allows the valve to be fully
deployed, assessed and then released, providing unparalleled
control during the procedure. The early valve function
provides hemodynamic stability throughout the procedure and if
necessary, the valve can be completely repositioned at any time
prior to release. The device also features a unique Adaptive
Seal™ designed to minimize the incidence of paravalvular
regurgitation, which has been identified as a predictor of
mortality in multiple clinical
trials.1,2,3
In the U.S., the Lotus Valve System is an investigational device
and not available for sale. It is a CE marked device,
available for sale in countries where CE marking is the regulation
in force. View or download an image of the Lotus Valve
System.
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
three percent of the population over age 65 and five 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.
About Boston Scientific
Boston Scientific transforms lives through innovative medical
solutions that improve the health of patients around the
world. As a global medical technology leader for more than 35
years, we advance science for life by providing a broad range of
high performance solutions that address unmet patient needs and
reduce the cost of healthcare. For more information, visit
www.bostonscientific.com and connect on Twitter and Facebook.
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1 Kodali SK, et. al. Two-Year Outcomes after
Transcatheter or Surgical Aortic-Valve Replacement. NEJM
2012;366:1685, http://www.nejm.org/doi/full/10.1056/NEJMoa1200384.
Accessed: April 25, 2013.
2 Tamburino C, et. al. Valvular Heart Disease. Circ
2011;123:299, http://circ.ahajournals.org/content/123/3/299.full.
Accessed: April 25, 2013.
3 Abdel-Wahab M et. al. Aortic regurgitation after
transcatheter aortic valve implantation: incidence and early
outcome. Results from the German transcatheter aortic valve
implantation registry. Heart 2011;97:899,
http://circ.ahajournals.org/content/123/3/299.full. Accessed:
April 25, 2013.
CONTACTS
Media: Ryan Davenport
Global Media Relations
Boston Scientific Corporation
(763) 494-2664 (office)
media@bsci.com
Simonetta Balbi
PR and Corporate Communication Europe
Boston Scientific Corporation
+ 39 3387936422 (mobile)
+ 39 0106060281 (direct)
Balbis@bsci.com
Investors: Susie Lisa, CFA
Investor Relations
Boston Scientific Corporation
(508) 683-5565 (office)
investor_relations@bsci.com
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SOURCE Boston Scientific Corporation