First patients ‘filter free’ after laser-assisted Inferior Vena
Cava (IVC) filter removal with Philips CavaClear
April 21, 2022
- First use of Philips' breakthrough CavaClear solution to help
patients with embedded IVC filters, including an athlete suffering
from a 16-year old penetrating filter
- Only FDA-cleared solution for advanced IVC filter removal
safely ablates tissue and removes embedded IVC filters in first
patients
- In the USA, estimates show more than one million patients with
IVC filters would benefit from filter removal to reduce the risk of
long-term complications [1,2]
Amsterdam, the Netherlands – Royal Philips
(NYSE: PHG, AEX: PHIA), a global leader in health technology, today
announced that the first patients have been successfully treated
for Inferior Vena Cava (IVC) filter removal using its IVC Filter
Removal Laser Sheath – CavaClear. CavaClear provides an effective,
minimally invasive solution for embedded IVC filters, to help
physicians reduce risk of significant filter-related complications
in patients and improve workflow performance. The first two
patients were successfully treated at Northwestern Medicine
(Chicago, IL) by Kush R. Desai, MD, FSIR, Associate Professor of
Radiology, Surgery, and Medicine, and Director of Deep Venous
Interventions, Division of Interventional Radiology at Northwestern
University Feinberg School of Medicine, and at Stanford Hospital
(Palo Alto, CA) by William T. Kuo, MD, FSIR, FCCP, FSVM, FACR,
FCIRSE, Professor of Interventional Radiology and Director of the
Stanford IVC Filter Clinic at Stanford University School of
Medicine.
IVC filters are used to treat patients with venous
thromboembolism, in which blood clots form in the deep veins of the
leg and groin and can travel through the circulatory system. They
are placed in the inferior vena cava to capture blood clots from
moving to the lungs. However, research has shown that IVC filters
may have long-term complications [3]. 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
penetration into adjacent organs and IVC occlusion. The FDA
recommends that implanting physicians consider removing retrievable
IVC filters as soon as they are no longer indicated [2].
CavaClear uses circumferential tissue ablation to aid in
capturing the filter within seconds of laser activation, which can
help increase procedural efficiency during removal and may help
lower costs by reducing the number of retrieval attempts needed to
remove an embedded filter. In addition, the simple and safe design
is easy for physicians to integrate into their workflow and reduce
the need for high-force retrievals that could increase the chance
of a complication.
“Millions of patients have IVC filters that are no longer
indicated, and CavaClear helps physicians experienced in IVC filter
retrieval work towards the goal of safely removing such devices, in
line with regulatory guidance,” said Dr. Desai.
Dr. Desai treated the first patient with CavaClear at
Northwestern Medicine by removing an IVC filter that was placed
over 6 months prior for deep vein thromboembolism. An attempt to
retrieve the filter was made approximately 4 months post implant at
another institution, however, the procedure was unsuccessful and
then referred to Dr. Desai. CavaClear was later successfully
applied to quickly and safely free the embedded filter from the
caval wall, enabling the patient to now be filter-free.
At Stanford Hospital, Dr. Kuo performed the first CavaClear
retrieval on a chronically embedded IVC filter that was placed more
than 16 years ago. The filter was rediscovered after the patient
developed lifestyle-limiting pain and blood vessel occlusions
related to the filter. Due to case complexity, none of the
patient’s original physicians outside of the USA were able to
provide a safe treatment plan and so referred the patient to the
Stanford IVC Filter Clinic.
The patient commented on his experience, “I am so thankful to
Dr. Kuo and the team for accepting me as a patient when none of my
doctors back home would even attempt removal of my 16-year-old IVC
filter, which was causing painful penetration and blood vessel
blockage requiring blood thinners. The worst thing is that I was
previously a cyclist and sportsman who used to ride more than 7000
miles per year, but after these blockages, I became so weak that I
could not even climb the stairs of my home. I now look forward to
exercising again. I want to thank all members of the team involved.
I will never get tired of saying thank you!”
“We chose to use CavaClear on a chronic filter implant that was
embedded for over 16 years and completely encased in scar tissue.
Prior to our discovery of the laser technique, pioneered at
Stanford [4], percutaneous removal would have been impossible, but
the use of CavaClear allowed us to achieve successful removal
within minutes – highlighting the first ever use of CavaClear to
remove a chronic filter implant. Although the device is now cleared
in the USA, embedded IVC filters remain a worldwide problem,” said
Dr. Kuo.
“We are deeply moved to see Philips IVC Filter Removal Laser
Sheath – CavaClear – have a positive impact on the lives of
patients, and the ability to provide physicians with access to a
safe, effective and efficient option for advanced IVC filter
removal,” said Atul Gupta, MD, Interventional Radiologist and Chief
Medical Officer for Image Guided Therapy at Philips. “These are
just the first of many successful cases to come, and a testament of
the Philips commitment to innovating procedures and solutions with
physician collaboration to improve patient outcomes.”
Regulatory recognition and research in support of
laser-assisted removalIn December 2021, Philips CavaClear
IVC Filter Removal Laser Sheath received FDA De Novo clearance,
becoming the first and only FDA-cleared solution for advanced IVC
filter removal. Failure rates for IVC filter removal can be high
and prior to CavaClear, limited options for removal existed if the
filter became difficult to remove. Advanced retrieval tools and
techniques are required if the IVC filter becomes embedded in the
vasculature. Physicians previously had very few tools to remove the
filter when complications occurred and until now there were no
FDA-approved devices for this type of advanced removal.
Philips IVC Filter Removal Laser Sheath – CavaClear is available
in the USA. For more information please go to
www.philips.com/CavaClear.
[1] Philips internal market research data calculation. [2]
Health, C. for D. and R. Safety Communications - Removing
Retrievable Inferior Vena Cava Filters: FDA Safety Communication.
(2014).[3] Van Ha, T. G. Complications of inferior vena caval
filters. Semin. Interv. Radiol. 23, 150–155 (2006).[4] 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).
For further information, please contact:
Joost Maltha Philips Global Press Office Tel:
+31 6 10 55
8116 Email: joost.maltha@philips.com
Fabienne van der FeerPhilips Image Guided TherapyTel: + 31 622
698 001E-mail: fabienne.van.der.feer@philips.com
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 78,000
employees with sales and services in more than 100 countries. News
about Philips can be found at www.philips.com/newscenter.
- Philips IVC Filter Removal Laser Sheath – CavaClear - 1
- Philips IVC Filter Removal Laser Sheath – CavaClear - 2
- Philips IVC Filter Removal Laser Sheath – CavaClear - 3
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