IVC FILTERS: WHAT IS IN THE MARKET NOWS

Dr. Iyad Feteih MBBch, FRCPC, DABR
King Fahd Hospital – Jeddah (MOH)
Consultant Interventional Radiologist
Head of Radiology Department
iyad.feteih@gmail.com
INFERIOR VENA CAVA FILTERS
WHAT IS OUT THERE?

HISTORIC PERSPECTIVES OF IVC
INTERRUPTION

• Armand Trousseau first proposed IVC
interruption for the treatment of PE in
1865.
• IVC interruption with surgical ligation
was first performed in 1893.
• Several surgical approaches were used
up until the 1960s.
Armand Trousseau
(1801-1867)

• Mid 1940s: Ochsner, DeBakey, and O’Neal
performed IVC ligation procedures to prevent
pulmonary emboli from the legs and pelvis.
• This method was associated with:
• High operative mortality rate (14%)
• Recurrent PE (6%)
• Chronic venous stasis (33%)
Michael
DeBakey

• The next innovation consisted of
Compartmentalization of the IVC with
sutures, staples, or clips (Miles, Moretz, and
Adams-DeWeese Clips).
• These methods still had significant issues:
•Operative mortality rates (12%)
•Recurrent PE (4%)
•IVC thrombosis

• The next generation of IVC interruption involved
Endoluminal methods.
• Mobin-Uddin umbrella (1967)

MOBIN-UDDIN UMBRELLA (1967)
• Constructed in the shape of an inverted
umbrella from six stainless-steel struts covered
with a thin heparin-impregnated fenestrated
silastic membrane.
• Inserted by venotomy with the apex pointing
inferiorly.
• Jugular insertion route only.

MOBIN-UDDIN UMBRELLA
• No longer available
• The device was limited due to:
•Migration (0.4%)
•Significant incidence of IVC
thrombosis (60%)
•Caused significant flow
disturbances and pressure
gradients. Ann. Surg. June 1977

GREENFIELD FILTER (1973)
• The next advance came in 1973,
with the Kim-Ray Greenfield filter.
• The Greenfield filter became the
device by which other devices are
compared.
Greenfield IVC
filter
Lazar J. Greenfield

GREENFIELD FILTER (1973)
• Conical filter
• Inserted via venotomy (sheath OD, 29.5 F)
• The original design is no longer commercially
available.
• The first percutaneous insertion in 1984.

The “Ideal” IVC Filter
• Non-thrombogenic
• Biocompatible
• Infinite implant lifetime
• High filtering efficiency
• No impedance of flow
• Secure fixation within IVC
• Low access site
thrombosis
•Ease of percutaneous
insertion
• Small caliber delivery
system
• Release mechanism simple
and controlled
• Amenable to repositioning
•MR imaging compatibility
•Low cost
•Retrievability

Inle Lake, Mayanmar (Burma)
Inthe (Son of the lake) «leg rower» fisherman

IVC FILTERS - CE MARKED
COMPANY NAME IVC FILTER NAME
ALN ALN IVC Filter
Argon Medical Devices, Inc. Option
Argon Medical Devices, Inc. Option Elite
Bard Peripheral Vascular, Inc. Recovery
Bard Peripheral Vascular, Inc. Recovery G2
Cook Medical Celect
Cook Medical Gunther Tulip
Cook Medical Bird’s Nest
Cordis Corporation OptEase
Cordis Corporation TrapEase
Crux Biomedical, Inc (Volcano) Crux Vena Cava Filter

IVC FILTERS – FDA APPROVED
COMPANY NAME IVC FILTER NAME
ALN ALN IVC Filter
Argon Medical Devices, Inc. Option
Argon Medical Devices, Inc. Option Elite
B. Braun Interventional Systems Vena Tech LP
B. Braun Interventional Systems Vena Tech LGM
Bard Peripheral Vascular, Inc. Eclipse
Bard Peripheral Vascular, Inc. Meridian
Bard Peripheral Vascular, Inc. Simon Nitinol
Boston Scientific Corporation Stainless Steel OTW Greenfield Filter (SGF)
Boston Scientific Corporation Titanium Greenfield Filter (TGF)
Cook Medical Celect
Cook Medical Gunther Tulip
Cook Medical Bird’s Nest
Cordis Corporation OptEase
Cordis Corporation TrapEase
Crux Biomedical, Inc (Volcano) Crux Vena Cava Filter

BARD
• Retrievable IVC Filters:
• Recovery (2003): first IVC filter in the USA to receive a
retrieval indication
• G2 (2005): Approved for permanent placement
• G2 Express (2008): Retrieval hook
• G2 X (2009): Enhanced delivery system
• Eclipse (2010): an electropolished version of the G2 X Filter
• Denali (2013): The newest IVC filter from Bard.
• Permanent IVC Filters:
• Simon Nitinol (1990)

RECOVERY G2 (2005)
BARD PV
• FDA Approval / CE Mark: 2005 (P), 2008 (R) / Yes
• Retrievable / Permanent: Retrievable
• Indicated IVC Diam. (mm): 28
• Max. Deployed Length (mm): --
• Introducer Catheter ID (Fr): 7
• Material: Nitinol
• Design: Conical
• Insertion Approach: Femoral/Jugular
• Retrieval Approach: Jugular
21

RECOVERY G2 (2005)
BARD PV
• It is an updated version of the Recovery filter, which
was taken off the market in 2005 due to problems with
fracturing and migration, and incorporates thicker fixation
hooks and a wider leg span.
• One study found a 95% retrieval success rate, with
median indwell time of 144 days and the longest indwell
time 300 days.
• However, a 2010 study found a 12% fracture rate of the
G2 filter.
22

RECOVERY G2 (2005)
BARD PV
• High rates of tilting and migration have also
been identified.
• It is likely that complications such as these
prompted the FDA to issue a safety alert
regarding adverse events in retrievable filters in
general.
23

G2 EXPRESS (2008) & G2 X (2009)
BARD PV
• A variant of the G2 Filter
• The G2X, has an apical
hook allowing for retrieval
using an endovascular
snare.
• The G2 Express Filter
name was changed to the
G2 X Filter with the
introduction of new
delivery systems

RECOVERY G2 X / EXPRESS (2009)
BARD PV
• FDA Approval / CE Mark: 2009 / Yes
• Max. Deployed Length (mm): 47
• Design: Conical
25

• Eclipse Filter is an
electropolished version
of the G2X Filter
ECLIPSE (2010)
BARD PV

BARD PV
• Introducer Catheter ID (Fr): 7 Femoral; 10 Jugular
• Design: Conical
27

• Titanium Anchors
• Designed to resist
caudal migration
MERIDIAN (2011)
BARD PV

ECLIPSE
BARD PV
• Introducer Catheter ID (Fr): 7 Femoral; 10 Jugular
• Design: Conical
29

DENALI
BARD PV
• Introducer Catheter ID (Fr): 8.4
• Design: Conical
• Insertion Approach: Jugular/Femoral
31

DENALI
BARD PV
32
Staggered Leg Lengths
4 Legs
• Cranial hook
• Penetration limiter
2 Longer Legs
• Caudal anchor
• Penetration limiter
• Electropolished one-
piece nitinol filter body
• New anchors help
prevent cranial and
caudal migration
• Unique penetration
limiters help limit
penetration

THE DENALI CLINICAL STUDY
• A single-arm, prospective, multi-center clinical study was
conducted to assess the safety of the Denali® Filter as
both a permanent and retrievable device.
• One hundred seventy five (175) patients (107 males, 68
females) were enrolled at 20 investigational sites across
the United States.
• The mean age was 56.7 ± 15.8 years (range 18 – 89
years).
• Eighty six (86) patients had their filter successfully
retrieved.
Denali Study Report

Complications Rates
Denali Study Report
Recurrent PE 2/175 1.1%
Caval Occlusion 0/129 0%
Filter Fracture 0/129 0%
Cranial Migration 0/128 0%
Caudal Migration 0/128 0%
Filter Penetration at placement 3/175 1.7%
Filter Penetration at retrieval 2/88 2.3%
Filter Tilt at placement 0/175 0%
Filter Tilt at retrieval 0/88 0%

Retrieval Details
Number of Filter Retrieval attempts 88
Number of Successful retrieval 86
Retrieval Success Rate 97.7%
Mean Indwell time 132.6 days
Maximum Indwell time 454 days
Mean Retrieval Procedure Time 17.1 minutes

CRUX (2013)
VOLCANO (CRUX BIOMEDICAL)

CRUX
• Indicated IVC Diam. (mm): 17-28
• Max. Deployed Length (mm): Depends on IVC Diam.
• Design: Helical
• Retrieval Approach: Jugular/Femoral
• Retrieval Window:
38

• Crux Biomedical, was founded
by Dr. Thomas Fogarty, a
surgeon, a famous medical
device inventor and noted
winegrower.
• Inventor of the Fogarty
embolectomy catheter (1969).
• He has acquired over 63 surgical
instrumentation patents over the
past 40 years.
CRUX

CRUX
• FDA approval in 2013
• Self-centering-no-tilt
• Symmetrical double helical design
• Centers filter automatically in vessel lumen
• Bi-directional deployment and retrieval, thus twice the
retrieval options of other filters.

CRUX
• Atraumatic design - Tissue anchor lengths
optimized for effective vessel fixation
• Trans-luminal filtration design provides filtration
across the lumen of the vessel
• Controlled filter placement via preloaded, low
profile, over-the-wire delivery system

CRUX

CRUX
• The safety and effectiveness of the Crux vena cava
filter was evaluated in the RETRIEVE 2, 3 and 4 pivotal
clinical trials, which enrolled 125 patients at high risk
for pulmonary embolism across 22 global sites
including the United States, Australia, New Zealand
and Belgium.
• Results demonstrated high rates of both successful
filter deployment (98%) and retrieval (98%).

CRUX
• Mean time for filter deployment: 5 minutes
• Mean time for filter retrieval: 7 minutes
• Femoral access:
• 85% of deployment cases
• 70% of retrieval cases.
• Results also showed high rates of safety and
effectiveness, with 0% embolization, migration (>2cm
per SIR guidelines) and filter fracture or filter tilting, and
no device-related adverse events requiring intervention
reported.

• World’s first optional filter
• Best suited for shorter-term
retrieval
• 94% probability of successful
retrieval at 12 weeks
• Contraindicated if IVC ID
measures >30mm
• Secure fixation
• Barbed anchors are designed
to achieve strong caval
fixation
GÜNTHER TULIP (2000)
COOK MEDICAL
Smouse HB, Rosenthal D, Thuong VH, et al. Long-term retrieval success rate profile
for the Günther Tulip vena cava filter. J Vasc Interv Radiol. 2009;20(7):871-877.
www.cookmedical.co
m

GÜNTHER TULIP (2000)
COOK MEDICAL
• FDA Approval / CE Mark: 2000 (P), 2003 (R) / Yes (1992)
• Material: ConiChrome
• Design: Conical
• Retrieval Window: Open?
47
www.cookmedical.co
m

• Long retrieval window
• At up to 51 weeks, the Celect’s
probability of successful
retrieval is 100%
• Contraindicated in vena cava
measuring >30mm & <15mm
• Accurate Placement
• Secondary strut design
centers filter with minimal
ingrowth
CELECT
COOK MEDICAL
Lyon SM, Riojas GE, Uberoi R, et al. Prospective study of the Cook Celect filter as a retrievable
device. Presented at: CIRSE 2008; September 13-17, 2008; Copenhagen, Denmark.
www.cookmedical.co
m

CELECT
COOK MEDICAL
• FDA Approval / CE Mark: 2007 (P), 2008 (R) / Yes
• Material: ConiChrome
• Design: Conical
• Retrieval Window: 51 weeks (open)
49
www.cookmedical.co
m

CELECT PLATINUM
COOK MEDICAL
www.cookmedical.co
m

CELECT PLATINUM
COOK MEDICAL
• Material: ConiChrome / Platinum
• Design: Conical
• Retrieval Window: Open?
51
www.cookmedical.co
m

• Similar features as
Celect
• Better trackability &
accurate placement with
flexible tip on femoral
introducer
• More visible due to
markers recognize tilt in
AP and Lateral view
CELECT PLATINUM
COOK MEDICAL
www.cookmedical.co
m

NAVALIGN DELIVERY:
• Provides procedural
assurance.
• 7-Fr introducer
• Hemostasis valve
• Radiopaque tips; decrease
the amount of contrast &
fluoroscopy time
COOK MEDICAL
www.cookmedical.co
m

OPTEASE (2000)
CORDIS
• Design: Double Basket
• Insertion Approach: Jugular/Femoral/Brachial
• Retrieval Approach: Femoral only
• Retrieval Window: 23 days
56

OPTEASE (2000)
CORDIS
• A 2009 study found a retrieval success rate of 93% but
with a mean interval of 11 days.
• Some studies have suggested a higher rate of IVC
thrombosis due to the double-basket design; overall
rates range from 0 to 12.5%.
• The retrieval window as indicated by the manufacturer
is relatively short at 23 days.
FDA approved for permanent use in 2002 and retrievable
use in 2004.
CE marked.

OPTEASE (2000)
CORDIS
• Recent “Class I” Recall
• Date Recall Initiated: March 29, 2013
• The recall covered 33,000 units distributed in the
United States between 05/06/2010 and 04/02/2013.
• Reason for Recall: Labeling correction to provide
clarification and additional information to minimize
likelihood of implanting the filter backwards.

ALN VENA CAVA FILTER (1997)
ALN IMPLANTS CHIRUGICAUX
www.aln2b.co

ALN VENA CAVA FILTER (1997)
• FDA Approval / CE Mark: 2008 / 1997
• Indicated IVC Diam. (mm): 28 (FDA), 32 (Europe)
• Material: 316L Stainless Steel
• Design: Conical
• Retrieval Window: Open
61

ALN VENA CAVA FILTER
• The ALN company was founded in 1997 by Alain Nigon
• 3 different approaches for insertion: jugular, brachial
and femoral
• Conical filter with 6 short legs to ensure IVC wall
fixation and 3 longer, centering legs, to avoid filter tilt.
www.aln2b.co

• Stainless Steel MRI Compatible
• No welding points No fractures
• Loaded in its filter holder and presented in its final
spatial form  No problems of non-opening of the filter
once released
• Easy and safe introduction
• ALN retrieval kit (cone) for retrieval
www.aln2b.co

Extraction Kit
www.aln2b.co
Filter Holder

• 1999: Started marketing an Extraction Kit, making the
ALN IVC filter “Optional”
• More than 7000 retrievals of ALN filters performed
• No limitations on retrieval window
• A 2008 study recorded a retrieval success rate of 99%
after a mean interval of 93 days
• To date there are documented retrievals after 40
months after implantation
www.aln2b.co

• Recently introduced
• It can be removed using
one of the ALN retrieval
kits or using a Snare
(jugular approach only)
ALN VENA CAVA FILTER WITH HOOK
www.aln2b.co

SAFEFLO
RAFAEL MEDICAL TECHNOLOGIES

SAFEFLO
• FDA Approval / CE Marked: May 2009 (P) / 2004
• Indicated IVC Diam. (mm): 15-27
• Max. Deployed Length (mm):
• Introducer Catheter ID (Fr):
• Material:
• Design: Cylindrical?
• Retrieval Approach: Femoral
69

SAFEFLO
• Designed by Elehanam Bruckheimer.
• SafeFlo is unique in that it provides an alternative
anchoring mechanism to the standard linear "legs and
hooks" or "box and hooks" designs of existing filters
currently available on the market.
• CE Mark approval: 2004 (P & R)
• FDA approval: 2009 (P only)

SAFEFLO
The SafeFlo filter offers the following advantages:
• Versatility and Control:
The SafeFlo filter can be fully deployed and then
collapsed back into its delivery sheath and redeployed
in a different position from both the femoral and
jugular approaches prior to active detachment from
the delivery system.

SAFEFLO
• Vessel Friendly:
• Fixation is by diffuse pressure on the full
circumference of the vessel wall provided by the
rings of the anchoring platform
• The lack of hooks is thought to allow for an
extended retrieval window.
• Sizes:
•Small (IVC diam. 15-19mm)
•Medium (IVC diam. 19-22mm)
•Large (IVC diam. 22-27mm)

OPTION (2009)
ARGON MEDICAL
www.argonmedical.co

OPTION (2009)
ARGON MEDICAL
• FDA Approval / CE Mark: June 8, 2009 / Yes
• Indicated IVC Diam. (mm): 32 (30 in USA)
• Max. Deployed Length (mm): 56.5
• Design: Conical
• Retrieval Window: Open (Recommended 175 days)
75

OPTION (2009)
ARGON MEDICAL
• A 2010 study recorded a retrieval success rate of 92%
with mean interval of 67 days.
• The maximum recommended retrieval window is 175
days.
76

OPTION ELITE (2014)
ARGON MEDICAL
www.argonmedical.co

OPTION ELITE (2014)
ARGON MEDICAL
• FDA Approval / CE Mark: January 2014
• Indicated IVC Diam. (mm): 32 (30 in USA)
• Max. Deployed Length (mm): 56.5
• Design: Conical
• Insertion Approach: Jugular/Femoral (OTW)
• Retrieval Window:
78

OPTION ELITE
ARGON MEDICAL
• Designed by Rex Medical
• The first retrievable vena cava filter approved
for Over-The-Wire (OTW) Delivery
• Enhanced retention anchor pattern
• Modified apex for ease of snaring
• Improved kink resistance and pushability of the
low profile (6.5FR OD) delivery sheath
• Safety: Color-coded filter introduction cartridge
www.argonmedical.co

PERMANENT IVC FILTERS
• Permanent/Non-retrievable IVC filters.
• Mainly used in patients who have short life-expectancy
(elderly, terminally diseased, untreatable metastatic
malignancies, etc.).

SIMON NITINOL (1990)
BARD PV
• FDA Approval / CE Mark: 1990 / 1998
• Retrievable / Permanent: Permanent
• Design: Bi-level Conical
• Insertion Approach: Femoral/Jugular/Antecubital

SIMON NITINOL (1990)
BARD PV
• First nitinol filter on the market.
• It has a similar design to the G2
• The main difference is that the upper level is composed
of loops of wire rather than struts.
• It has a good record with low rates of recurrent PE and
few major complications.

TRAPEASE
CORDIS
• FDA Approval / CE Marked: 2000 /
• Design: Double basket
• Insertion Approach: Femoral/ Jugular/Antecubital

TRAPEASE
CORDIS
• Has a similar design to the OptEase
• One difference is the provision of proximal and
distal hooks designed to prevent migration in
either the caudal or cephalad directions
• It has a low rate of filter thrombosis.

GIANTURCO-ROEHM BIRD'S NEST FILTER
(1982)
COOK MEDICAL

COOK MEDICAL
• FDA Approval / CE Marked: 1982 / Yes
• Material: 304L Stainless Steel
• Design: Varying unique design

COOK MEDICAL
• Has a unique design with two V-shaped struts
supporting a random tangle of very fine wires.
• It is made of biocompatible 304L stainless steel
which results in marked MR susceptibility
artifact.
• It is the only filter that can be used in megacavas
(up to 40mm diameter); made possible by the
60mm span of the struts.

COOK MEDICAL
• Placement is technically more complex than
most filters.
• The wires may prolapse on insertion and for this
reason it should not be placed in a suprarenal
location to avoid prolapse into the heart.
• It requires a 12 F delivery system.

VENA TECH LGM
B. BRAUN
• Indicated IVC Diam. (mm): 28 (FDA)
• Introducer Catheter ID/OD (Fr): 10
• Material: Phynox™, a non-ferromagnetic alloy
• Design: Conical

VENA TECH LP
B. BRAUN
• FDA Approval / CE Marked: 2001/ Yes
• Indicated IVC Diam. (mm): 28 (FDA), 35 (CE)
• Material: Phynox™, a non-ferromagnetic alloy
• Design: Conical

VENA TECH LP
B. BRAUN
Antecubital Introducer Sheath
System:
•A 96 cm Introducer system
allows filter delivery through the
right or left antecubital vein
•Introducer Sheath remains kink-
free up to 55 degree angulation
•Radiopaque tip is highly visible
for accurate placement

TITANIUM GREENFIELD - TGF (1989)
BOSTON SCIENTIFIC

TITANIUM GREENFIELD - TGF (1989)
BOSTON SCIENTIFIC
• Material: Beta III Titanium Alloy
• Design: Conical

STAINLESS STEEL OTW GREENFIELD–SGF
(1995)
BOSTON SCIENTIFIC

STAINLESS STEEL OTW GREENFIELD-SGF
BOSTON SCIENTIFIC
• FDA Approval / CE Marked: 1995/ Yes
• Material: 316 L Surgical Stainless Steel
• Design: Conical

MMPI Drug-Eluting IVC Filters
• The major causes of filters retrieval failure were intimal
overgrowth and severely tilted filter with apex embedded
into the caval wall.
• Matrix metalloproteinases (MMPs) play a key role in
neointimal hyperplasia.
• It is documented that neointimal hyperplasia can be
reduced by inhibiting MMP activity and hence smooth
muscle cell migration.
• MMP inhibitors (MMPI) can potently inhibit the activity of
MMPs.
Xiao L., Wang M. MMPI drug-eluting IVC filter decreases adhesion between caval wall
and filter. Cell Biochem Biophys. 2013 Mar;65(2):159-61.

MMPI Drug-Eluting IVC Filters
• The hypothesis is that a drug-eluting filters which
contains MMPI may inhibit IVC neointimal
hyperplasia and decrease the adhesion between
vascular wall and filter struts.
• This may improve the long-term prognosis of venous
thromboembolism patients.
Xiao L., Wang M. MMPI drug-eluting IVC filter decreases adhesion between caval wall
and filter. Cell Biochem Biophys. 2013 Mar;65(2):159-61.

SUMMARY
• There are numerous IVC filters available in the US,
European and international markets.
• All of these filters have gone through studies and
trials demonstrating their efficacy in preventing
pulmonary embolism with reduced risk of
complications.
• Continued R&D in this area is focusing on producing
devices that are easier to deal with by the
interventionist and safer for the patients.

iyad.feteih@gmail.com
THANK YOU!

IVC FILTERS: WHAT IS IN THE MARKET NOWS

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