Five-year ILLUMENATE EU RCT and Pivotal study results confirm safety profile of Philips Stellarex .035” low-dose drug-coate...
25 January 2021 - 11:35PM
Five-year ILLUMENATE EU RCT and Pivotal study results confirm
safety profile of Philips Stellarex .035” low-dose drug-coated
balloon
January 25, 2021
Two major randomized controlled trials (RCTs) show no difference
in mortality between patients treated with the Philips Stellarex
drug-coated balloon (DCB) and those treated with percutaneous
angioplasty (PTA), the current standard of care
Amsterdam, the Netherlands – Royal Philips (NYSE: PHG,
AEX: PHIA), a global leader in health technology, today announced
the final, five-year results of two major randomized controlled
trials (RCTs) that show no difference in all-cause mortality
between patients treated with the Stellarex drug-coated balloon
(DCB) and those treated with percutaneous angioplasty (PTA), the
current standard of care. Moreover, the studies showed no
difference in mortality between the Stellarex DCB and PTA at every
12-month endpoint over the course of the study. Results from the
two RCTs were presented at the virtual 2021 Leipzig Interventional
Course (LINC).
The ILLUMENATE EU RCT and ILLUMENATE Pivotal RCT together
comprised approximately 600 patients in Europe and the U.S. After
five years, the ILLUMENATE EU RCT showed 19.3% mortality among
patients treated with the Stellarex DCB compared to 19.4% mortality
for those treated with PTA. The five-year results for the
ILLUMENATE Pivotal study also show no statistically significant
difference among patients treated with the Stellarex DCB (21.2%)
compared to those treated with PTA (20.2%). Both studies had a high
vital status follow-up compliance, with the status of over 90% of
patients known.
“The five-year final results show favourable overall safety of
the Stellarex low-dose paclitaxel DCB, and are applicable within an
extensive patient cohort,” said Marianne Brodmann, MD, Professor,
vascular specialist at the Medical University of Graz, Austria,
primary investigator for both trials and a paid consultant to
Philips. “Every year, the Stellarex program has demonstrated low
mortality rates with no difference in rates between the two patient
cohorts.”
“These study results build on the robust, consistent long-term
data of the Stellarex program and confirm the safety and
performance of our unique DCB,” said Chris Landon, Senior Vice
President and General Manager Image Guided Therapy Devices at
Philips. “The Stellarex DCB, with its low drug dose and unique drug
coating composition, continues to be an important treatment choice
for healthcare providers treating patients with peripheral arterial
disease.”
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.
Philips’ Image Guided Therapy business provides complete
procedural solutions of systems, smart devices, disease-specific
software and services for minimally invasive procedures, helping
caregivers decide, guide, treat and confirm the right therapy for
each patient during their procedure.
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 Philips
Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health
technology company focused on improving people's health and
well-being, 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 2020 sales of EUR 19.5 billion and
employs approximately 82,000 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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