News |
Gore Receives FDA Approval for Larger Diameter, Small Profile
AAA Endoprosthesis
W. L. Gore & Associates (Gore) announced the availability of the 31 mm diameter version of the GORE
EXCLUDER® AAA Endoprosthesis. The device provides physicians with a safe and effective
endovascular option to treat abdominal aortic aneurysms (AAAs) in patients with aortic inner neck
diameters from 27 to 29 mm. Other important enhancements include a flat-top design that enables
greater production efficiency, an additional pair of proximal anchors to help ensure excellent fixation,
and a lengthening of the trunk from 7 to 8 cm to accommodate larger anatomies. More
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Gore Releases Updates on GORE PROPATEN® Vascular Graft Studies
Encouraging interim results from several multi-center, multi-year, worldwide studies of the GORE PROPATEN® Vascular Graft were
recently announced. The studies report encouraging outcomes for below-knee bypass and dialysis access. The data were presented to
clinical audiences at the 35th Annual VEITHsymposium™ in New York and Deutsche Gesellschaft für Gefäßchirurgie in Germany.
The primary patency of the GORE PROPATEN® Vascular Graft in below-knee bypass was reported to be 59% at five years. Additionally,
in dialysis access, the GORE PROPATEN® Vascular Grafts were found to have a significant 20% improvement in clot-free survival at
one year as compared to the non-heparin bonded graft control group. The study updates presented support the use of the GORE
PROPATEN® Vascular Graft as the prosthetic graft of choice in lower limb and dialysis access applications. All dialysis access studies
have been conducted in the US. To view complete text please visit: www.goremedical.com/propaten/news.
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First Data on GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface Presented at TCT
The GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface has surpassed its non-heparin predecessor in units sold within the
United States and is continuing to gain traction in Europe after its recent approval. While numerous multi-limb studies document the
performance of the non-heparin GORE VIABAHN® Endoprosthesis in the treatment of superficial femoral artery (SFA) obstructive disease,
data is emerging that characterizes the performance of the GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface. An abstract
published from the 2008 Transcatheter Therapeutics annual meeting in Washington, DC, demonstrates short-term safety of the
heparin-bonded device. The study examines platelet count change, heparin-induced thrombocytopenia type II (HIT) occurrence, and graft
occlusion rate in 45 patients treated with the GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface for their SFA disease.
Additionally, at the six month follow-up interval, there were no occurrences of HIT or graft occlusion. "We believe for long segment SFA
occlusions and stenosis that the heparin bonded GORE VIABAHN® Device is a safe alternative to self-expanding nitinol stents used in the
SFA," says Dr. Tanvir Bajwa, the Milwaukee group's principal investigator. While limited in scope and early in follow-up, this study begins to
explore the clinical impact of the GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface in SFA disease.
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FDA Approval Received for Modifications to the GORE TAG® Thoracic Endoprosthesis
Gore has received approval from the US Food and Drug Administration (FDA) to market a modified version of the GORE TAG® Thoracic
Endoprosthesis for the treatment of thoracic aortic aneurysms (TAAs). The improved delivery catheter enhances the previous version of
the GORE TAG® Thoracic Endoprosthesis by adding a soft flexible tip to the leading end of the delivery system. The soft tip improves
flexibility at the wire / catheter interface to facilitate tracking through challenging aortic anatomy. The hub component has also been
modified to improve ease of use and durability. Gore has already begun distribution of the upgraded delivery system, and plans to have
this completed across the US within the next few months.
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Product Updates |
Enhanced GORE Tri-Lobe Balloon Catheter Available Soon
Recently approved for CE Mark and cleared by the FDA, the enhanced GORE Tri-Lobe Balloon Catheter
is a low-pressure, compliant, tri-lobed polyurethane balloon catheter designed to assist in the dilation of
self-expanding endoprostheses in large diameter blood vessels. The lobed design of the balloon catheter
allows for inflation without complete blockage of aortic blood flow. The enhancements made to the new
GORE Tri-Lobe Balloon Catheter include a change from silicone to polyurethane balloons, decreased
inflation and deflation times, more uniform and simultaneous inflation of the three lobes, smoother
transitions on the leading end of the balloon catheter, and a reinforced catheter hub.
The GORE Tri-Lobe Balloon Catheter with enhanced design will be available in two sizes, both of which are 18 Fr introducer sheath compatible.
The small balloon catheter is approved for use in aortic inner diameters from 16 mm to 34 mm. The large balloon catheter is approved for use in
aortic inner diameters from 26 mm to 42 mm.
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Gore Receives FDA Conditional Approval to Begin Clinical Studies for
the Next Generation GORE TAG® Thoracic Endoprosthesis
Gore has received conditional approval from the US Food and Drug Administration (FDA) to begin
investigation of the Next Generation GORE TAG® Device for the treatment of descending thoracic
aortic aneurysm, traumatic aortic transection, and acute complicated type B dissection. Three distinct
clinical studies are being initiated to establish safety and efficacy in the three primary etiologies for
which the GORE TAG® Device is implanted. All three studies will be prospective, multicenter
and non-randomized.
The Next Generation GORE TAG® Device is designed to improve conformability, resist compression, and expand the treatment range of the
commercially available device to treat aortic neck diameters ranging from 16 - 24 mm.
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New GORE PROPATEN® Vascular Graft Line Extensions Released
To continue to meet your needs, we have released three additional catalogue numbers to the family of GORE PROPATEN® Vascular Grafts.
Catalogue
Number |
|
Description |
|
Internal
Diameter (mm) |
|
Ringed
Section
Length (cm) |
|
Length (cm) |
| H470080A |
Standard-walled,
stretch technology |
4 -7 |
N/A |
80 |
| H060060A |
Standard-walled,
stretch technology |
6 |
N/A |
60 |
| H080060A |
Standard-walled,
stretch technology |
8 |
N/A |
60 |
| HT074050A |
Thin-walled,
removable ring,
stretch technology |
7 |
40 |
50 |
| HT076080A |
Thin-walled,
removable ring,
stretch technology |
7 |
60 |
80 |
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Endo Updates |
79 Year-Old Pizza Delivery Boy Saved by Fast Acting Gore Sales Associate
and GORE EXCLUDER® Device
An inspiring story about the use of the GORE EXCLUDER® Device appeared in the Oregonian, the daily newspaper in Portland, Oregon, on
March 22, 2009. The article, written by reporter Margie Boule, profiles Roger Jehan, a 79 year-old pizza delivery "boy" who has survived two
ruptured abdominal aortic aneurysms. The article notes that his most recent rupture was treated using a stent-graft (GORE EXCLUDER®
Device) that could be placed in Roger's aneurysm through an incision in his groin. More
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Linc 2009 — Leipzig Interventional Course 2009 –
January 14-17, 2009 — Leipzig Germany
For this year's course debate, arguments were set forth for which treatment should be considered the
first for AAA — open repair or endovascular therapy. Dr Marc RHM van Sambeek FESC Department of
Vascular Surgery Catharina Hospital Eindhoven, The Netherlands argued that EVAR should be the
primary option for all patients with suitable anatomy, citing results from EVAR and the DREAM trial.
He emphasized the favorable results regarding fit patients. He also presented on how results have
improved with newer generation endografts. More
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Duplex Ultrasonography Alone Is Sufficient for Mid-Term EVAR Surveillance:
A Prospective Cost-Analysis Study
Beeman BR, Doctor L, Dougherty MJ, Doerr K, McAfee-Bennett S, Calligaro KD. Duplex ultrasonography alone is sufficient for mid-term EVAR
surveillance: a prospective cost-analysis study. Abstract presented at the 37th Annual Symposium of the Society for Clinical Vascular Surgery;
March 18-21, 2009; Ft. Lauderdale, Florida
OBJECTIVES:
After initially performing both serial CT scans and DU in our early experience with EVARs, we performed a prospective study using DU as the sole
surveillance study and determined cost savings and outcome using this strategy. More
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Case Study |
GORE EXCLUDER® AAA Endoprosthesis in Tortuous Anatomy
Heitham Hassoun, MD
Johns Hopkins Hospital
Baltimore, Maryland, USA
CLINICAL CHALLENGE
The patient is an active 85-year-old gentleman with a history of smoking and a family history of aortic aneurysm.
He underwent a CT scan for
transient abdominal pain at an outside hospital and a 6 cm infrarenal AAA was discovered. He has had no history of heart disease, and his
ejection fraction by echocardiogram was 60%. He was recommended to undergo an open repair because of his tortuous left iliac artery. He
subsequently self-referred to Johns Hopkins Hospital for a second opinion. More
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Events |
2009 Events (through October)
| |
Date |
|
|
Name |
|
|
Location |
| |
Gore Events |
|
|
|
|
|
|
| |
August 3 – 4 |
|
|
AAA Workshop |
|
|
Los Angeles, California |
| |
August 6 – 7 |
|
|
Advanced AAA Symposium |
|
|
Chicago, Illinois |
| |
August 7 |
|
|
Aortic Technology Forum |
|
|
Flagstaff, Arizona |
| |
September 1 |
|
|
Endo and Surgical Technology Showcase |
|
|
Flagstaff, Arizona |
| |
October 2 |
|
|
Endo and Surgical Technology Showcase |
|
|
Flagstaff, Arizona |
| |
Supported Congresses |
|
|
|
|
|
|
| |
September 3 – 6 |
|
|
European Society of Vascular Surgery |
|
|
Oslo, Norway |
| |
September 19 – 23 |
|
|
Cardiovascular and Interventional Radiological
Society of Europe |
|
|
Lisbon, Portugal |
| |
September 22 – 26 |
|
|
Transcatheter Cardiovascular Therapeutics |
|
|
San Francisco, California |
| |
October 17 – 21 |
|
|
European Association for Cardiothoracic Surgery |
|
|
Vienna, Europe |
| |
October 19 – 22 |
|
|
Vascular Interventional Advances |
|
|
Las Vegas, Nevada |
|
Clinical Literature |
Literature Recommendations
TAA
Adams JD, Angle JF, Matsumoto AH, et al. Endovascular repair of the thoracic aorta in the post-FDA approval era. Journal of Thoracic &
Cardiovascular Surgery 2009;137(1):117-123.
Xenos ES, Minion DJ, Davenport DL, et al. Endovascular versus open repair for descending thoracic aortic rupture: institutional
experience and meta-analysis. European Journal of Cardio-thoracic Surgery 2009;35(2):282-286.
Lin PH, Huynh TT, Kougias P, Huh J, LeMaire SA, Coselli JS. Descending thoracic aortic dissection: evaluation and management in the
era of endovascular technology. Vascular & Endovascular Surgery 2009;43(1):5-24.
Criado FJ. Endograft repair in the thoracic aorta: Poised to Grow! Vascular Disease Management 2009;7(1):A4-A6.
Halawa M, Patterson B, Holt P, Thompson M, Loftus IM. Comparisons between thoracic stent grafts- how do we know which stent graft
to select? Vascular Disease Management 2009;7(1):13-19.
PERIPHERAL VASCULAR TREATMENT
Hugl B, Nevelsteen A, Daenens K, et al; PEPE II Study Group. PEPE II - a multicenter study with an end-point heparin-bonded expanded
polytetrafluoroethylene vascular graft for above and below knee bypass surgery: determinants of patency. Journal of Cardiovascular
Surgery 2009;50(2):195-203.
Daenens K, Schepers S, Fourneau I, Houthoofd S, Nevelsteen A.Heparing-bonded ePTFE grafts compared with vein grafts in
femoropopliteal and femorocrural bypasses: 1-and 2-year results. Journal of Vascular Surgery 2009; 49(5):1210-1216.
AAA
Bos WTGJ, Tielliu IFJ, van den Dungen JJAM, et al. Results of endovascular abdominal aortic aneurysm repair with selective use of the
Gore EXCLUDER. Journal of Cardiovascular Surgery 2009;50(2):159-164.
Matsumura JS, Katzen BT, Sullivan TM, Dake MD, Naftel DC; EXCLUDER Bifurcated Endoprosthesis Investigators. Predictors of survival
following open and endovascular repair of abdominal aortic aneurysms. Annals of Vascular Surgery 2009;23(2):153-158.
Performance in EVAR. Endovascular Today 2009;8(1)Supplement:3-11.
Deaton DH, Mehta M, Kasirajan K, et al.The phase I multicenter trial (STAPLE-1) of the Aptus endovascular repair system: results at 6
months and 1 year. Journal of Vascular Surgery 2009;49(4):851-858.
Qu L, Raithel D. From clinical trials to clinical practice: 612 cases treated with the Powerlink stent-graft for endovascular repair of AAA.
Journal of Cardiovascular Surgery 2009;50(2):131-137.
Cao P, De Rango P, Parlani G, Verzini F; Talent Unidoc Retrospective Italian Study (TAURIS) Group. Durability of abdominal aortic
endograft with the Talent Unidoc stent graft in common practice: core lab reanalysis from the TAURIS multicenter study. Journal of
Vascular Surgery 2009;49(4):859-865.
Lall P, Gloviczki P, Agarwal G, et al. Comparison of EVAR and open repair in patients with small abdominal aortic aneurysms: can we
predict results of the PIVOTAL trial? Journal of Vascular Surgery 2009;49(1):52-59.
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