Philips receives FDA Breakthrough Device Designation for laser-assisted IVC filter removal device
July 21 2021 - 8:00AM
July 21, 2021
- FDA Breakthrough Device Designation is granted to novel medical
devices that have the potential to provide more effective
treatment
- It is estimated that in the United States more than one million
patients with inferior vena cava (IVC) filters would benefit from
filter removal to reduce the risk of long-term complications
- Laser for IVC filter removal is intended to safely ablate
tissue to remove embedded filters
- Limited options exist for embedded IVC filter removal, and
independent studies indicate high success rates using a Philips
excimer laser sheath
Amsterdam, the Netherlands – Royal Philips
(NYSE: PHG, AEX: PHIA), a global leader in health technology, today
announced the FDA has granted Breakthrough Device Designation (BDD)
for a laser-assisted inferior vena cava (IVC) filter removal
device. The proposed device is intended for ablating tissue to
remove an IVC filter when previous methods of removal have
failed.
IVC filters are used to treat patients with venous
thromboembolism, in which blood clots form in the deep veins of the
leg, groin or arm and can travel through the circulatory system.
They are placed in the inferior vena cava to capture blood clots
from moving to the heart or lungs. Research has shown that IVC
filters may have long-term complications [1]. The filters can
fracture and travel through the bloodstream to other parts of the
body. Other identified long-term risks associated with IVC filters
include lower limb deep vein thrombosis and IVC occlusion. The FDA
recommends that implanting physicians consider removing retrievable
IVC filters as soon as they are no longer indicated [2].
The failure rate for IVC filter removal is high and limited
options for removal exist if the filter has become difficult to
remove. Advanced retrieval tools and techniques are required if the
IVC filter becomes embedded in the vasculature [3]. Physicians have
very few tools to remove the filter when this happens and there are
no FDA-approved devices for this type of advanced removal.
Recent research supports laser-assisted
removal
Two independent and prospective clinical studies demonstrated
that laser-assisted retrieval was 96-99% effective with a major
adverse event rate of 0.7-2% [3][4].
“Laser-assisted filter retrieval may be a critical tool for the
safe retrieval of filters with extended implantation times,” said
Kush R Desai, MD, FSIR, Associate Professor of
Radiology, Surgery, and Medicine, and Director of Deep Venous
Interventions at Northwestern University Feinberg School of
Medicine, Chicago, Illinois, USA. “Breakthrough Device Designation
reflects the potential impact that this technology could have on
countless patients where this technology can be applied to safely
retrieve filters by an expert physician, thereby reducing their
risk of significant filter-related complications.”
“There is a clear need for an innovative device to help
physicians more safely perform advanced IVC filter removal and I
believe that the Philips excimer laser sheath may greatly enhance
the options available to succeed in filter retrieval,” said Atul
Gupta, MD, Interventional Radiologist and Chief Medical Officer,
Image Guided Therapy, at Philips. “Breakthrough Device Designation
is an important step for a medical innovation such as this one to
help fill an unmet need in patient care.”
FDA Breakthrough Device Designation is granted to novel medical
devices that have the potential to provide more effective treatment
or diagnosis of life-threatening or irreversibly debilitating
diseases or conditions. The goal of the Breakthrough Devices
Program is to provide patients and healthcare providers with timely
access to breakthrough medical devices. Under the program, the FDA
will provide Philips with priority review and interactive
communication regarding device development throughout the
submission process.
Stay informed on developments – click
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[1] Van Ha, T. G. Complications of inferior vena caval filters.
Semin. Interv. Radiol. 23, 150–155 (2006).[2]
Health, C. for D. and R. Safety Communications - Removing
Retrievable Inferior Vena Cava Filters: FDA Safety Communication.
(2014). Available at:
http://wayback.archive-it.org/7993/20170722215731/
https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm396377.htm.[3]
Kuo, W. et al. Laser‐Assisted Removal of Embedded Vena Cava
Filters: A First‐In‐Human Escalation Trial in 500 Patients
Refractory to High‐Force Retrieval. Journal of the American
Heart Association 9:24, 1-9 (2020).
https://www.ahajournals.org/doi/pdf/10.1161/JAHA.119.017916[4]
Desai, K. et al. Excimer Laser Sheath-Assisted Retrieval of
“Closed-Cell” Design Inferior Vena Cava Filters. J Am Heart Assoc;
9: e017240 (2020).
For further information, please contact:
Joost MalthaPhilips Global Press OfficeTel: +31 610 558
116Email: joost.maltha@philips.comTwitter: JoostMaltha
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 well-being, 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 2020
sales of EUR 17.3 billion and employs approximately 77,000
employees with sales and services in more than 100 countries. News
about Philips can be found
at http://www.philips.com/newscenter
- Philips Headquarters Amsterdam
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