- Two-year data from the ILLUMENATE European randomized
clinical trial (EU RCT) validates durable clinical performance of
Stellarex low-dose drug-coated balloon
- Trial includes 328 peripheral arterial disease patients
from 18 centers across Germany and
Austria
AMSTERDAM and LAS VEGAS, Sept. 14,
2017 /CNW/ -- Royal
Philips (NYSE: PHG; AEX: PHIA), a global leader in health
technology, announced the two-year results from the ILLUMENATE
European randomized clinical trial (EU RCT) demonstrating the
efficacy of Philips Spectranetics' Stellarex .035" drug-coated
balloon (DCB) for peripheral arterial disease (PAD) in comparison
to uncoated balloon angioplasty. Marianne
Brodmann, M.D., of the Medical University of Graz in Austria, presented the data today as a
late-breaking trial at the Vascular Interventional Advances (VIVA
17) Annual Conference.
The ILLUMENATE EU RCT, which is part of a series of five trials
evaluating the safety and efficacy of Stellarex for superficial
femoral artery and popliteal disease, includes 328 PAD patients
from 18 centers across Germany and
Austria and compares the Stellarex
DCB to an uncoated angioplasty balloon. The results show that at 24
months, 75.9% of patients treated with Stellarex maintained blood
flow through the treated segment of the diseased artery, assessed
through blinded core-lab adjudicated patency. Only 61.0% of
patients treated with an uncoated balloon still maintained blood
flow at 24 months. The data shows that Stellarex demonstrates
higher efficacy and patency results, and longer treatment
durability compared to an uncoated balloon, which is the current
standard of care in the United
States.
"The Stellarex DCB produced durable results in this rigorous
trial, validating earlier findings among the ILLUMENATE trial
series," stated Marianne Brodmann,
M.D. "These consistent, top-tier outcomes are achieved with a
low-dose balloon.* Stellarex is the first low-dose DCB to
demonstrate a significant treatment effect at two years."
The ILLUMENATE EU RCT has independent evaluation including
supervision by a clinical events committee, a data safety and
monitoring board, and assessment by angiographic and duplex
ultrasound core laboratories. Philips Spectranetics fully funded
the ILLUMENATE EU RCT as part of the ILLUMENATE series of five
trials to evaluate the benefits of Stellarex .035" for various
patient groups in comparison to an uncoated percutaneous
transluminal angioplasty (PTA) balloon, which is the current
endovascular standard of care.
"We are committed to providing proven clinical solutions that
positively impact patient outcomes," stated Christopher Barys, Image Guided Therapy Devices
Business Leader for Philips. "We are proud to have the only
low-dose drug-coated balloon with a proven treatment effect at two
years compared to the current endovascular standard of care in the
U.S. The addition of Stellarex in the Philips portfolio through the
Spectranetics acquisition reinforces our commitment to helping
physicians decide, guide, treat and confirm the right therapy for
their patients."
The Stellarex drug-coated balloon is designed to restore and
maintain blood flow to arteries in patients with peripheral
arterial disease. Spectranetics launched the device in Europe in January
2015 and received FDA approval in the U.S. in July 2017. Philips acquired Spectranetics in
August 2017 to continue the
advancement of its unique portfolio of image-guided therapy
solutions to deliver enhanced care for patients.
Visit the Philips and Spectranetics booths (406 and 405) at VIVA
17 to experience Stellarex and Philips' other innovative offerings
that deliver seamless care in the vascular space. Follow the
#VIVA17 conversation at @PhilipsLiveFrom throughout the event.
* 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:
Alicia Cafardi
Philips Group Press Office
Tel: +1 412-523-9616
E-mail: Alicia.Cafardi@philips.com
Kathleen Lozen
Philips Image Guided Therapy Devices
Tel: +1 617-529-2958
E-mail: Kathleen.Lozen@philips.com
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' health technology portfolio generated 2016 sales of
EUR 17.4 billion and employs
approximately 71,000 employees with sales and services in more than
100 countries. News about Philips can be found at
www.philips.com/newscenter.
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SOURCE Royal Philips