Third-party evaluation confirms safety profile of Philips Stellarex .035″ low-dose drug-coated balloon
October 01 2019 - 04:00AM
Third-party evaluation confirms safety profile of Philips Stellarex
.035″ low-dose drug-coated balloon
October 1, 2019
- Primary safety analysis of Stellarex drug-coated balloon (DCB)
three-year data, comprising the largest published, pooled set of
randomized controlled trial (RCT) data for a single
paclitaxel-based device, shows no difference in mortality between
patients treated with the Philips Stellarex DCB and those treated
with percutaneous angioplasty, the current standard of care
- Findings also identified no device-related deaths and no
correlation of Stellarex DCB to late all-cause mortality
- The analyses represent one of industry’s most extensive and
rigorous safety assessments of a paclitaxel-based device, and were
published in Circulation, a peer-reviewed journal of the American
Heart Association
Amsterdam, the Netherlands – Royal Philips
(NYSE: PHG, AEX: PHIA), a global leader in health technology, today
announced the results of third-party analyses of patient-level data
from worldwide clinical trials of the Philips Stellarex .035″
low-dose DCB. The analyses, which were performed by US-based
contract research organization Syntactx, were published today in
Circulation, a peer-reviewed journal of the American Heart
Association.
The safety analyses applied validated statistical tests commonly
accepted for large-scale meta-analyses. The primary analysis
examined the three-year patient-level data from the ILLUMENATE
Pivotal trial and the ILLUMENATE European Randomized Controlled
Trial (EU RCT), which together included a total of 589 patients.
419 were treated with Stellarex DCB to restore and maintain blood
flow to arteries in the legs (above the knee), and 170 patients
were treated with an uncoated percutaneous angioplasty (PTA)
balloon, the current standard of care. Only 2.3% of patients in the
Pivotal study and 3.7% of patients in the EU RCT were lost to
follow-up within the respective three-year follow-up windows. The
additional analysis comprised the two Stellarex DCB RCTs in
addition to the four Stellarex DCB single-arm studies in the
meta-analysis, including 2,495 patients with peripheral artery
disease, of which 2,325 were treated with Stellarex DCB to restore
and maintain blood flow to arteries in the legs (above the
knee).
The primary safety analysis demonstrated that there is no
difference in mortality between patients treated with Stellarex DCB
and uncoated PTA through three years. It also identified no
device-related deaths and no correlation of Stellarex DCB to late
all-cause mortality. These findings were confirmed and reinforced
by the additional analysis.
“This manuscript further substantiates the results presented
earlier this year at the 2019 Leipzig Interventional Course (LINC)
in Leipzig, Germany,” said Sean Lyden, MD and Chairman of the
Department of Vascular Surgery, Cleveland Clinic (U.S.), co-Primary
Investigator for the ILLUMENATE Pivotal trial, and senior author of
the safety manuscript. “The systematic analysis included a robust
statistical method to ensure we could pool the individual patient
data from the trials in order to enhance the accuracy of the
results.”
“After a careful, detailed and appropriately directed analysis
of the controlled data available from the Stellarex suite
of studies, we have a robust assessment of the patient-level
outcomes related to the Stellarex drug-coated balloon,” said
William Gray, MD, FACC, FSCAI, President of the Lankenau Heart
Institute, and lead author of the safety manuscript. “We are
confident in the finding of no difference in
mortality rates between patients treated with Stellarex and those
treated with PTA.”
As the study sponsor, Philips was involved in study design and
data collection, but was not involved in the analysis or
interpretation of data. Sean Lyden and William Gray have consulting
relationships with Philips, but have not received financial
compensation from Philips in connection with their role in this
analysis.
“The results of this study, combined with the recently presented
three-year efficacy data, confirm our confidence in the safety and
performance of our unique Stellarex low-dose drug-coated balloon,”
said Chris Landon, general manager Image Guided Therapy Devices at
Philips. “We are committed to providing healthcare providers with
accurate and transparent data in order to help them make an
informed decision on the optimal treatment for patients with
peripheral arterial disease. We believe Stellarex, with its low
drug dose and unique drug coating composition, is a logical choice
for those who need this option.”
Featuring Philips EnduraCoat technology, a unique coating
consisting of a polyethylene glycol excipient with amorphous and
crystalline paclitaxel particles dispersed in it, Stellarex .035″
DCB is unlike any other drug-coated balloon for the treatment of
peripheral artery disease. EnduraCoat technology provides efficient
drug transfer and effective drug residency coupled with high
coating durability and minimal particulate loss, thereby enabling a
low therapeutic drug dose.
Stellarex is the only low-dose DCB to demonstrate a significant
treatment effect and high safety profile through three years. The
ILLUMENATE Pivotal trial showed durable primary patency (maintained
blood flow) in the most complex patient pool ever studied in a DCB
randomized clinical trial.
For further information, please contact:
Mark GrovesPhilips Global Press OfficeTel.: +31 631 639
916E-mail: mark.groves@philips.com
Fabienne van der FeerPhilips Image Guided TherapyTel: + 31 622
698 001E-mail : fabienne.van.der.feer@philips.com
About Royal PhilipsRoyal Philips (NYSE: PHG,
AEX: PHIA) is a leading health technology company focused on
improving people's health and enabling better outcomes across the
health continuum from healthy living and prevention, to diagnosis,
treatment and home care. Philips leverages advanced technology and
deep clinical and consumer insights to deliver integrated
solutions. Headquartered in the Netherlands, the company is a
leader in diagnostic imaging, image-guided therapy, patient
monitoring and health informatics, as well as in consumer health
and home care. Philips generated 2018 sales of EUR 18.1 billion and
employs approximately 78,000 employees with sales and services in
more than 100 countries. News about Philips can be found
at www.philips.com/newscenter.
- Philips Stellarex low dose drug coated balloon
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