MARLBOROUGH, Mass.,
May 18, 2021 /PRNewswire/ -- Data
presented at hotline and late-breaking trial sessions today at the
EuroPCR 2021 congress demonstrated positive procedural
performance, including low rates of paravalvular leakage (PVL) and
permanent pacemaker implementation (PPI), of the Boston Scientific
(NYSE: BSX) ACURATE neo2™ Aortic Valve
System within the investigator-initiated Early neo2
Registry1 and ITAL-neo Registry2 studies.
"These real-world findings reinforce the effectiveness of the
ACURATE neo2 valve design enhancements –including
the 60% larger outer sealing skirt to conform to challenging
anatomies – that have minimized PVL and shown
excellent clinical outcomes in a broad spectrum of patients
when compared to data collected with the previous-generation
ACURATE neo™ Aortic Valve System," said Dr. Ian Meredith, global chief medical officer,
Boston Scientific.
EARLY neo2 Registry Results
The Early neo2 Registry, presented by Dr. Andreas Rück,
interventional cardiologist, Karolinska University Hospital
Stockholm, is the first large real-world report of
clinical experience with the ACURATE neo2 device.
Key findings from this retrospective analysis of 554 patients from
12 European centers included:
- 1.3% post-operative moderate/severe PVL rate which was lower
than the rate observed in prior studies with the ACURATE neo
device. The mild and none/trace PVL rates were 33.3% and 65.4%,
respectively.3
- 6% in-hospital PPI rate, 2.1% in-hospital stroke rate,
1.3% mortality rate at 30 days and excellent
hemodynamics (mean gradient of 9mmHg).
Early neo2 Registry data were further evaluated in a
separate quantitative assessment of angiographic
aortic regurgitation in 228 patients treated with either the
ACURATE neo valve system or ACURATE neo2 valve
system, also presented by Dr. Rück at EuroPCR as a
poster.4 These results demonstrated that the ACURATE
neo2 device was associated with significantly less aortic
regurgitation when compared with the prior-generation ACURATE
neo device. The mean aortic regurgitation fraction rate
(the percentage of blood that flows back through the aortic valve)
was 4.4% with the ACURATE neo2 device vs. 9.9% with the
ACURATE neo device (p<0.001). This equates to a 56%
relative reduction in the mean aortic regurgitation fraction.
ITAL-neo Results
The retrospective ITAL-neo Registry, which was presented by Dr.
Andrea Buono, interventional
cardiologist, Fondazione Poliambulanza Istituto Ospedaliero in
Brescia, Italy, included 95 TAVI
patients from nine Italian centers and evaluated in-hospital device
success and in-hospital patient outcomes with the ACURATE
neo2 device. Findings included:
- 3.1% pre-discharge moderate/severe PVL rate. This rate, in
addition to the mild and none/trace PVL rates (56.9% and 40%), was
lower than previously reported rates in studies of the ACURATE
neo device.5,6
- 97.9% device success rate, 1.1% in-hospital stroke
rate, 11.2% in-hospital new PPI rate and
excellent hemodynamics (pre-discharge mean gradient of
8.2 mmHg).1
About the ACURATE neo2 Valve System
The ACURATE neo2 Valve System received CE Mark in
2020 and is indicated for patients with aortic stenosis – with
no specified age or risk level – who are considered appropriate
candidates for transcatheter aortic valve implantation by their
heart team, including a cardiac surgeon.
Boston Scientific is currently enrolling patients in the ACURATE
IDE, the pivotal U.S. trial evaluating the safety of the ACURATE
neo2 Aortic Valve System. In April
2021, the company received FDA approval to modify the trial
design to study patients with severe, symptomatic aortic stenosis
who are at low risk of open-heart surgery, in addition to those at
intermediate, high and extreme risk.
*In the U.S., the ACURATE neo2™ Aortic Valve System is an
investigational device and not available for sale.
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 40 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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the meaning of Section 27A of the Securities Act of 1933 and
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CONTACTS:
Angela Mineo
Media Relations
(763) 955-8325 (office)
Angela.Mineo@bsci.com
Susie Lisa, CFA
Investor Relations
(508) 683-5565 (office)
BSXInvestorRelations@bsci.com
1 Rück A. Results from the Early neo2
registry Acurate neo2 TAVI valve. Euro PCR 2021
conference. 2021.
2 Buono A. Short-term
outcomes of a novel self-expanding device: ITAL-neo Registry. Euro
PCR 2021 conference. 2021.
3 Transcatheter Aortic Valve Replacement With the
ACURATE neo2 Valve System: 1 Year Clinical and Hemodynamic
Outcomes. Presented by H. Möllmann at TVT Chicago
2019.
4 Ruck A. Quantitative Angiographic Assessment of Aortic
Regurgitation Following the ACURATE neo2 Versus ACURATE neo –Valve
implantation. Euro PCR 2021 conference. 2021.
5 Lanz J., et al. Lancet. 2019;394(10209):1619-28.
6 Tamburino C., et al. Circulation
2020;142:2431–2442.
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SOURCE Boston Scientific Corporation