Safety and efficacy of Philips’ Stellarex .035 low-dose drug-coated balloon demonstrated in clinical trials at three years
May 29 2019 - 12:00PM
May 29, 2019
- Stellarex is the only low-dose [1] drug-coated balloon (DCB) to
demonstrate a significant treatment effect and high safety profile
through 3 years
- ILLUMENATE Pivotal trial showcases durable primary patency
(maintained blood flow) in the most complex patient pool studied in
a DCB randomized clinical trial
- No significant difference in mortality compared to standard of
care through three years
Amsterdam, the Netherlands and New
Orleans, U.S. – Royal Philips (NYSE: PHG; AEX: PHIA), a
global leader in health technology, today announced the three-year
results from the ILLUMENATE Pivotal trial and the ILLUMENATE
European randomized clinical trial (EU RCT). These two trials are
part of a series of five trials evaluating the safety and efficacy
of Stellarex .035″ low-dose [1] DCB to restore and maintain blood
flow in the superficial femoral artery and popliteal arteries of
patients with peripheral arterial disease. The results were
evaluated compared to treatment with uncoated balloons, the current
standard of care.
S. Jay Mathews, M.D., of Bradenton Cardiology Center in
Bradenton, Florida, U.S., presented the data today as a
late-breaking trial at the New Cardiovascular Horizons (NCVH19)
Annual Conference, and highlighted the following results:
- The ILLUMENATE Pivotal trial results show that at 36 months,
64.2% of the patients treated with Stellarex maintained blood flow
through the treated segment of the diseased artery, compared to
51.0% of the patients treated with an uncoated balloon,
demonstrating continued durability of the procedure.
- The ILLUMENATE Pivotal patient pool was the most complex
studied in a randomized clinical trial. The pool included patients
with the highest rates of comorbidities, such as diabetes and renal
insufficiency, while 43.9% also had severely calcified lesions.
- The ILLUMENATE EU RCT results show that at 36 months, 67.5% of
the patients treated with Stellarex maintained blood flow (assessed
through blinded core-lab adjudicated patency), compared to 59.9% of
the patients treated with an uncoated balloon.
- Through three years, both studies showed no significant
difference in mortality compared to treatment with uncoated
balloons. The mortality rate of patients treated with Stellarex in
the ILLUMENATE Pivotal trial was 10.1%, compared to the mortality
rate of patients treated with an uncoated balloon of 11.0%. The EU
RCT showed mortality rates of 9.4% for patients treated with
Stellarex, compared to 8.5%for patients treated with an uncoated
balloon.
“The three year data of the ILLUMENATE Pivotal trial and
ILLUMENATE EU RCT add to the robust and consistent multi-year data
of the Stellarex program,” said S. Jay Mathews, M.D. “The
demonstrated durability of Stellarex in the complex patient pool of
the ILLUMENATE Pivotal trial, which are patients that are at high
risk for restenosis, a recurring blockage, is unique in the
industry. Moreover, we continue to see no significant difference in
mortality rates between patients treated with Stellarex and those
treated with uncoated balloons, which confirms our confidence in
the safety profile of Stellarex.”
“We are committed to providing clinically proven image-guided
therapy solutions that enhance the procedure and positively impact
patient outcomes,” said Bert van Meurs, Chief Business Leader,
Image Guided Therapy at Royal Philips. “Stellarex is the only
low-dose drug-coated balloon with a proven treatment effect at
three years compared to the existing standard-of-care in the U.S.
and Europe. The combination with our interventional imaging
systems, such as the successful Azurion platform, our
recently-introduced IntraSight intravascular diagnostic application
platform, and associated services, enables clinicians to decide,
guide, treat and confirm the appropriate peripheral vascular
treatment.”
The announcement of the three-year results from the ILLUMENATE
Pivotal trial and the ILLUMENATE EU RCT follows the release in
January 2019 of the most recent pooled analysis of patient-level
data of over 2,300 patients treated with Philips’ Stellarex DCB in
above-the-knee (ATK) studies, which reinforced the strong safety
profile of Stellarex.
The Stellarex .035 DCB is designed to restore and maintain blood
flow in diseased femoral and popliteal arteries, and is FDA
approved in the US and CE marked in Europe. Stellarex is unlike any
other drug coated balloon in the industry for the treatment of
peripheral artery disease as it features the EnduraCoat Technology,
a unique coating consisting of polyethylene glycol as the base
material, the so-called ‘excipient’, and a combination of amorphous
and crystalline paclitaxel particles dispersed in it. EnduraCoat
provides efficient drug transfer, effective drug residency with
high coating durability and minimal particulate loss, and therefore
enables a low therapeutic drug dose.
[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:
Steve KlinkPhilips Group Press Office Tel: +31 6
10888824E-mail: steve.klink@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 77,000 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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