Philips introduces new 200mm and 150mm Stellarex 0.035” low-dose drug-coated balloons to broaden treatment options for peri...
October 15 2019 - 04:00AM
Philips introduces new 200mm and 150mm Stellarex 0.035” low-dose
drug-coated balloons to broaden treatment options for peripheral
artery disease patients
October 15, 2019
Stellarex’s unique coating enables a low therapeutic drug dose
and has demonstrated a significant treatment effect and high safety
profile
Amsterdam, the Netherlands – Royal Philips
(NYSE: PHG, AEX: PHIA), a global leader in health technology, today
introduced two new balloons to its Stellarex 0.035” low-dose
drug-coated balloon (DCB) portfolio. The new 200mm and 150mm
Stellarex 0.035” low-dose DCBs have received approval from the U.S.
Food and Drug Administration (FDA) for the treatment of de novo and
restenotic lesions in native superficial femoral or popliteal
arteries, both arteries in the upper leg. The new balloons broaden
physicians’ treatment options for peripheral artery disease (PAD)
patients with a high risk of restenosis and expand the Stellarex
portfolio, which has a proven significant treatment effect and high
safety profile. The 200mm and 150mm Stellarex 0.035” low-dose DCBs
are now available in the U.S. and will be rolled out to other
markets in due course.
PAD affects more than 200 million people worldwide [1]. If left
untreated, it can result in critical limb ischemia (CLI). 34% of
patients with CLI undergo amputation within one year of diagnosis.
Broadening physicians’ treatment options helps ensure more PAD
patients will receive treatment before the disease progresses.
“With its unique coating, Stellarex is unlike any other DCB in
the industry for the treatment of PAD,” said Chris Landon, General
Manager, Image Guided Therapy Devices at 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. By expanding our range of Stellarex balloons, we are
adding to the treatment options that physicians can use to provide
optimal care for each patient with peripheral arterial
disease.”
All Philips’ Stellarex DCBs feature EnduraCoat technology, a
unique coating consisting of a polyethylene glycol excipient with
amorphous and crystalline paclitaxel particles dispersed in it. The
coating provides efficient drug transfer and effective drug
residency coupled with high coating durability and minimal
particulate loss, thereby enabling a low therapeutic drug dose. The
Stellarex balloon is now available in 40, 60, 80, 100, 120, 150,
and 200mm lengths for the treatment of lesions in the superficial
femoral and popliteal arteries with vessel diameters of 4-6mm.
The results of third-party analyses of patient-level data from
worldwide clinical trials of the Philips Stellarex 0.035″ low-dose
DCB in lengths under 150mm were recently published in Circulation,
a peer-reviewed journal of the American Heart Association. Primary
safety analysis of Philips Stellarex DCB three-year data,
comprising a large published, pooled set of randomized controlled
trial (RCT) data for a single paclitaxel-based device, showed no
difference in mortality between patients treated with the Philips
Stellarex DCB and those treated with percutaneous angioplasty, the
current standard of care. The analyses represent one of industry’s
most extensive and rigorous safety assessments of a
paclitaxel-based device.
The 200mm and 150mm Stellarex 0.035” low-dose DCBs are the
latest innovation in Philips’ unique portfolio of devices to
support image-guided therapy procedures. Offering precise, accurate
and efficient tools helps physicians decide, guide, treat and
confirm the right therapy for the right patient at the point of
care. In addition to Stellarex DCBs, Philips has leading positions
in IVUS (intravascular ultrasound) catheters that produce
ultrasound images of the interior of blood vessels, as well as FFR
(fractional flow reserve) and iFR (instantaneous free wave)
catheters that are used to assess the blood flow. iFR technology is
unique to Philips. Our integrated solutions advance minimally
invasive procedures for patients with coronary artery disease,
peripheral artery disease and lead extraction indications.
[1] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6113064/
For further information, please contact:
Mark GrovesPhilips Global Press OfficeTel: +31 631 639 916Email:
mark.groves@philips.comTwitter: mark_groves
Fabienne van der FeerPhilips Image Guided TherapyTel: +31 622
698 001Email: fabienne.van.der.feer@philips.comTwitter: 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 2018
sales of EUR 18.1 billion and employs approximately 78,000
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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