New data reconfirms long-term safety profile of the Philips Stellarex low-dose Drug-Coated Balloon
26 June 2020 - 6:00PM
June 26, 2020
Amsterdam, the Netherlands – Royal Philips (NYSE: PHG,
AEX: PHIA), a global leader in health technology, today announced
the four-year results from the ILLUMENATE European Randomized
Controlled Trial (EU RCT). The Stellarex DCB cohort demonstrated
similar all-cause mortality compared with the control arm through
four years. This analysis included missing data found post hoc to
achieve a follow-up compliance of 93.9%, increasing the robustness
of the statistical analysis. Along with the recently-published data
on the ILLUMENATE Pivotal trial, this is the second RCT which has
indicated similar mortality rates, further validating the long-term
safety profile of Philips’ Stellarex low-dose Drug-Coated Balloon
[1]. The data were presented in the evening of 25 June as part of
Vascular Interventional Advances’ (VIVA) first-ever late-breaking
clinical trials livestream.
The four-year ILLUMENATE EU RCT data are the latest from a
series of trials evaluating the safety and efficacy of the Philips
Stellarex .035″ DCB in restoring and maintaining blood flow in the
superficial femoral artery and popliteal arteries of patients with
peripheral arterial disease. The results were evaluated compared to
percutaneous transluminal angioplasty (PTA) treatment with uncoated
balloons, the current standard of care. The mortality rate at four
years shows no statistical difference between two patient groups,
at 17.7% for the Stellarex patient group and 14.1% for the control
group. Secondary safety outcomes were also similar across the two
groups.
“These latest data from the ILLUMENATE EU RCT study add to the
ILLUMENATE Pivotal RCT results and continue to demonstrate no
statistical difference in mortality when comparing the DCB and PTA
arms of the trial,” said William Gray, MD, FACC, FSCAI, and
President of the Lankenau Heart Institute, an investigator for the
Stellarex clinical trials who presented the results during the
livestream.
“The results from the ILLUMENATE EU RCT trial continue to
demonstrate durable long-term results at a high rate of follow-up
compliance,” said Marianne Brodmann, MD, Professor, vascular
specialist at the Medical University of Graz, Austria and a primary
investigator for the trial.
“The ILLUMENATE EU RCT results now establish Stellarex as the
only paclitaxel DCB that has shown a consistent lack of statistical
difference in mortality compared with PTA at each annual follow-up
through four years across two randomized controlled trials,” said
Chris Landon, General Manager, Image Guided Therapy Devices at
Philips. “We continue to proactively communicate relevant clinical
findings to ensure physicians can make the best-informed decision
for each patient.”
Featuring Philips EnduraCoat technology, a unique coating
consisting of a polyethylene glycol excipient with amorphous and
crystalline paclitaxel, the 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.
[1] Low-dose DCBs are those that deliver a dose of only 2
micrograms of the drug paclitaxel per square millimeter, which is
lower than some other DCBs on the market.
For further information, please contact:
Mark GrovesPhilips Global Press OfficeTel: +31 631 639 916
Email: mark.groves@philips.com Twitter: mark_groves
Fabienne van der FeerPhilips Image Guided TherapyTel: +31 622
698 001Email: fabienne.van.der.feer@philips.com Twitter:
FC_Feer
About Royal Philips
Royal 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 2019
sales of EUR 19.5 billion and employs approximately 81,000
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
Koninklijke Philips NV (NYSE:PHG)
Historical Stock Chart
From Apr 2024 to May 2024
Koninklijke Philips NV (NYSE:PHG)
Historical Stock Chart
From May 2023 to May 2024