Four-year data from ILLUMENATE Pivotal trial reaffirms safety profile of Philips Stellarex low-dose Drug-Coated Balloon
January 28 2020 - 10:00AM
Four-year data from ILLUMENATE Pivotal trial reaffirms safety
profile of Philips Stellarex low-dose Drug-Coated Balloon
January 28, 2020
- Mortality rates similar to standard of care through four years
with excellent rate of follow-up compliance
- Philips Stellarex is the only low-dose Drug-Coated Balloon
(DCB) to demonstrate sustained treatment effect and high safety
profile through four years
Amsterdam, the Netherlands and Leipzig, Germany – Royal
Philips (NYSE: PHG, AEX: PHIA), a global leader in health
technology, today announced the four-year results from the
randomized controlled ILLUMENATE Pivotal trial in the U.S. With an
excellent follow-up compliance rate of over 95% in a highly complex
disease patient cohort, the data show similar mortality rates
through four years for patients treated with Stellarex compared to
those treated with the current standard of care (plain balloon
angioplasty). The results were presented at the Leipzig
Interventional Course today, January 28th, by Sean Lyden, MD,
Chairman of the Department of Vascular Surgery, Cleveland Clinic
(U.S.), and co-Primary Investigator for the ILLUMENATE Pivotal
trial [1].
The four-year ILLUMENATE Pivotal trial data are the latest data
from a series of trials evaluating the safety and efficacy of the
Philips Stellarex .035″ low-dose [2] 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 four-year data from the ILLUMENATE Pivotal trial further
substantiates the three-year results that were presented at LINC
2019 and published in Circulation in 2019,” said Sean Lyden, MD.
“The high compliance follow-up rate further affirms the findings of
these data in a complex patient population.”
The study’s patient population is complex with a high proportion
suffering from severely calcified lesions. The mortality rate at
four years was virtually identical between the two patient groups,
at 15.6% for the Stellarex patient group and 15.2% for the control
group. Secondary safety outcomes were also similar across the two
groups. The four-year data also show a clinically relevant lower
rate of clinically-driven target lesion revascularization (CD-TLR)
in the Stellarex DCB patient group of 28.2%, vs 34.1% in the
control group. CD-TLR is a commonly used indicator of treatment
efficacy durability.
“The ILLUMENATE Pivotal four-year data builds on the robust,
consistent long-term data of the Stellarex clinical evaluation
program,” said Chris Landon, general manager, Image Guided Therapy
Devices at Philips. “We continue to make relevant data available to
healthcare providers in order to help them make an informed
decision on the optimal treatment for often complex disease
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, 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.
[1] As the study sponsor, Philips was involved in the study
design and data collection but was not involved in the analysis or
interpretation of the data. Sean Lyden has a consulting
relationship with Philips but has not received financial
compensation from Philips with regard to the Pivotal data analysis
and presentation.[2] 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 80,000
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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