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Briefing
Introduction & Key messages
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Philips is announcing the global commercial introduction (ex-US) of VesselNavigator. A new
live 3D image guidance solution to support clinicians during live image guided interventions
taking place in the vessel network.
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One of the key applications of VesselNavigator is guidance during treatment of aortic
aneurysms: a complex and high risk intervention that demands the highest level of precision
and accuracy of stent placement.
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With VesselNavigator Philips is further expanding its leading Hybrid Suite proposition.An
integral solution to perform open and minimally invasive procedures in a single room.
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VesselNavigator gives clinicians a new level of visual guidance during catheters navigation
inside the body towards the location of treatment and supports and guides during stent
placement / treatment.
VesselNavigator offers the following key benefits
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Patient risk is decreased. The amount of contrast agent needed can be limited by 70
percent. [1 Ref Pubmed: Tacher et al; J Vasc Interv Radiol. 2013 Nov;24(11):1698-706].
This is important as contrast agency is toxic to the kidney and one can endure only a
limited amount during their lifetime.
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Complexity of procedure can be better managed by visual guidance, decreasing the
amount of time it takes to do a procedure by 18% (6,3 hrs – 1,1 hrs)
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The introduction underlines Philips’ innovation leadership in image guided therapies and
comes after recent other announcements such as the acquisition of Volcano and other live
3D image guidance solutions such as EmboGuide, EchoNavigator en EP Navigator.
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Technological developments in realtime image guided therapies offer valuable new options
in the treatment of cardiovascular and heart diseases, and more recently also in the
treatment of cancers. Image guided therapies can help in highly complex and time
consuming procedures to reduce the overall procedure time and amount of contrast agent
used, thereby improving the overall risk profile for the patient.
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As a leader in image guided therapies it’s our ambition to – in close collaboration with
leading clinical and industrial partners - advance the development of innovative technologies
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that enable non-invasive, more accurate and localized therapies that are supported with
realtime image guidance, 3D navigation and clinical IT.
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The number of procedures globally grows with CAGR 10%.
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70.000 procedures a year in the USA. [EU more than 40.000 procedures expected for 2015]
Aortic aneurysm & its treatment
An aortic aneurysm is a general term for an enlargement of
the aorta to greater than 1.5 times normal size. They are most
commonly located in the abdominal aorta, but can also be
located in the thoracic aorta.
Aortic aneurysms cause weakness in the wall of the aorta and
increase the risk of aortic rupture. The aneurysm usually is
asymptomatic, but may occasionally cause pain in the back, and
is considered a sign of impending rupture. When rupture occurs,
massive internal hemorrhage results, and, unless treated
immediately, shock and death can occur.
Surgery (open or endovascular) is the definite treatment of an aortic aneurysm. Medical therapy
is typically reserved for smaller aneurysms or for elderly, frail patients where the risks of surgical
repair exceed the risks of non-operative therapy (observation alone).
Open surgery typically involves exposure of the dilated portion of the aorta and insertion of a
synthetic (Dacron or Gore-Tex) graft (tube). Once the graft is sewn into the proximal (toward the
patient's head) and distal (toward the patient's foot) portions of the aorta, the aneurysmal sac is
closed around the graft. Alternatively, the anastomosis can be carried out with expandable
devices, a simpler and quicker procedure.
In the recent years, the endovascular treatment of aortic aneurysms has emerged as a
minimally invasive alternative to open surgery repair.
The first successful endovascular exclusion of an aneurysm took place in Argentina by Juan
Parodi in 1991. The endovascular treatment of aortic aneurysms involves the placement of an
endo-vascular stent through small incisions at the top of each leg into the diseased portion of
the aorta. This technique has been reported to have a lower mortality rate compared to open
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surgical repair, and is now being widely used not only in individuals with comorbid conditions
that make them high risk patients for open surgery, but also now in lower risk individuals.
DETAILS
Q.
A.
What is VesselNavigator
VesselNavigator is live 3D image guidance solution intended to assist in the
treatment of vascular diseases during an endovascular intervention procedure.
VesselNavigator can be used during any endovascular intervention.
Q.
A.
How is VN helping clinicians?
Vascular Surgeons have been educated in open surgery treatment and come
from a practice where they built their treatment plan based on what they
encountered when opening the body. Over time they have been making a shift
towards imaging as well, mainly using 2D imaging and with the concept of 3D
image fusion technology only just becoming established amongst the innovators
in the field. Despite its broad adoption, conventional 2D x-ray imaging and
endovascular procedures are still perceived as if a dimension is missing, like the
anatomical information they used to have in open surgery. VesselNavigator is for
vascular surgeons a revolutionary tool, bringing back the 3D anatomy as they
were used to in open surgery.
Q.
A.
How does VesselNavigator work?
It provides live 3D image guidance for navigating endovascular devices through
intended vascular structures in the body, reusing previously acquired diagnostic
CTA or MRA images. The created 3D volume can be used as a 3D roadmap for
navigation; live 2D fluoroscopic images will be overlaid on the 3D
volume.
Q.
A.
For what kind of medical conditions is VN meant?
Complex aortic aneurysm treatment is a very important procedure, but the tool
can be used for any endovascular procedure, mainly abdominal.
Q.
A.
How many people suffer from aortic aneurysms?
In the Netherlands men 1,3% tot 8,9% and women1,0% tot 2,2%. These
numbers are the same outside the Netherlands in for instance the UK. In the
United States, the incidence of abdominal aorta aneurysms is 2 to 4 percent in the adult
population.
Q.
A.
What causes aortic aneurysm
There are multipal causes e.g. genetic, lifestyle, (won’t mention this in the article)
Q.
A.
Patient benefit?
There is an increasing population of diabetic and aging patients, that suffer from
poor kidney function. This population can have little contrast. The use of
VesselNav opens up a minimal invasive treatment option for this population
and/or improves quality of life by the reduced amount of contrast needed.
For these groups, limiting the amount of contrast is of the utmost importance.
During development there was great focus on this group of patients specifically
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that now can undergo minimally invasive treatment of aortic aneurysm.
Q.
A.
What are the clinical benefits of VN?
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It brings back 3D anatomy to the surgeons used to open surgery procedures.
A study of 23 patients has shown an average reduction of contrast medium
usage of 72% (235 – 65ml.) during complex aortic aneurysms
Shorter procedure times (6.3 – 5.2 hrs) in case of aortic belly procedures
(FEVAR, Branched EVAR)
Q.
Are these benefits clinically proven via clinical studies?
A.
Yes.
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Q.
A.
With whom did Philips partner in the development of VN?
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Q.
A.
1 Ref Pubmed: Tacher et al; J Vasc Interv Radiol. 2013 Nov;24(11):1698-706
2 Ref Pubmed: Sailer et al; Eur J Vasc Endovasc Surg. 2014 Apr;47(4):34956
UZ Gent, Prof. dr. Frank Vermassen (Belgium)
UniKlinik, Prof. Dr. Jan Brunkwall (Germany)
BIDMC, Prof. Schermerhorn (USA)
How does VN differ from the other live 3D navigation solutions that you
announced the past few years?
VesselNavigator is a technology that helps in the treatment of endovascular
diseases during procedures such as (but not limited to) AAA, TAA, carotid
stenting, iliac intervention by providing 3D live image guidance by superimposing
live fluoroscopic images on a pre-acquired CTA or MRA volume.
Over the past three years we have announced:
HeartNavigator (2011): A technology that helps interventional cardiologists and
cardiac surgeons to perform minimally-invasive structural heart disease repairs
by providing an intelligently integrated view of live X-ray and 3D ultrasound
images.
EP Navigator (2007): A technology that visualizes 3D cardiac anatomy and the
position of catheters, in real time, in one image, in the EP interventional lab.
EchoNavigator (2013): A technology that helps interventional cardiologists and
cardiac surgeons to perform minimally-invasive structural heart disease repairs
by providing an intelligently integrated view of live X-ray and 3D ultrasound
images.
EmboGuide (2014): EmboGuide is a live 3D image guidance tool that supports
the increasing number of minimally-invasive procedures. It is designed for use in
conjunction with Philips’ interventional X-ray system to perform tumor
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embolization procedures. Such procedures involve blocking the arteries feeding
a tumor to deprive it of nutrients and oxygen. They require the insertion of a
catheter, which must be guided to the tumor site with the aid of live imageguidance.
Q.
How does your solution differ from what competition has?
A.
Both Siemens and GE have a VesselNavigator type of solution on the level of
image fusion technology for navigation. However, Siemens still promotes their 3D
roadmap solution for the treatment of EVARs instead of their image fusion
solution. The main difference with GE is that we have both 2D and 3D 3D
registration and GE only has 2D 3D registration. It is hard to claim but we think
we our tool is easiest in use (which is very important for customers using the
tool).
Q.
A.
What type of clinicians will use VN
Interventional radiologists and vascular surgeons.
Q.
What growth is expected in the field of image guided vascular
interventions?
In the past ten years the vascular field experienced a change from open surgery
to minimally invasive procedures, where the use of live 3D imaging has become
a standard. The number complex vascular interventions using this technique are
growing 10% CAGR. VN was designed to support this trend and to make
(complex vascular interventions) easier to perform with limited risk.
A.
Q.
A.
Where will VN be available?
VesselNavigator is being globally introduced, except for the North American
market.
Q.
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Why is VN not available in the USA yet and when will it be available there?
VesselNavigator is currently awaiting FDA approval. This is expected around end
of August.
Q.
Is there a correlation with you recent announcement concerning the
acquisition of Volcano?
Yes, on a strategic level that is. Both announcements fit out ambition to be an innovation
leader in image guided therapies and to advance the development of innovative
technologies that enable non-invasive, more accurate and localized therapies that are
supported with realtime image guidance, 3D navigation and clinical IT.
A.
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