GORE REPORTS FIRST PATIENT TREATED USING GORE^® C3 DELIVERY SYSTEM FOR GORE^® EXCLUDER^® AAA ENDOPROSTHESIS

Gore reported the first clinical uses of the GORE^® C3 Delivery System to deploy the GORE^® EXCLUDER^® AAA Endoprosthesis. The device received approval from the US Food and Drug Administration (FDA) in December 2010. The first procedures were successfully performed by vascular surgeons and interventionalists at medical centers of excellence around the US. This game-changing new technology represents a leap forward in medical innovation by allowing physicians to deploy the graft in a controlled manner to the contralateral gate, assess position relative to the anatomy, and reposition if necessary to maximize accuracy and infrarenal seal.

The added deployment control provides physicians increased confidence in treating challenging anatomies, as well as cannulation options with the ability to bring the contralateral gate toward the contralateral guidewire. The ability to reposition the device may minimize complications that could occur if the graft were malpositioned after initial deployment. The GORE^® C3 Delivery System retains Gore's hallmark ease-of-use and features an intuitive three-step progression to deploy and reposition the stent-graft.

The first US procedures to treat patients with an AAA using the new system were performed by:

• Michel Makaroun, MD and Robert Rhee, MD, University of Pittsburgh Medical Center (UPMC) Vascular Surgery
• Mark Fillinger, MD and William Tanski, III, MD, Dartmouth-Hitchcock Medical Center
• Claudio Schönholz, MD, and Joseph Hart, MD, University of South Carolina
• Alan Lumsden, MD, Methodist Hospital
• Jon Matsumura, MD, University of Wisconsin
• David Minion, MD, University of Kentucky

According to Dr. Makaroun, Chief of the Division of Vascular Surgery and Professor of Surgery at UPMC, a 70-year-old woman with a large aneurysm and diseased aortic neck successfully received the first GORE^® EXCLUDER^® AAA Endoprosthesis featuring C3 Delivery System at UPMC. "The constraining mechanism worked very nicely to allow repositioning of the GORE^® EXCLUDER^® Device, a feature that will increase our confidence in treating challenging aortic neck anatomies. The deployment mechanism remains quite simple and easy to use."

Dr. Fillinger, Professor of Surgery and Director, Vascular Surgery Training Programs, Dartmouth-Hitchcock Medical Center, commented, "In our particular case, we purposely chose a patient with difficult and unusual anatomy for the GORE^® C3 Delivery System. The ability to reposition the device after seeing how it would accommodate the anatomy was extremely helpful, and made the case go as smoothly as possible."

Dr. Matsumura, Professor, Department of Surgery and Chairman, Division of Vascular Surgery, University of Wisconsin, added, "Our patient had difficult proximal aortic neck anatomy, and the combination of both a robotic, multi-axis imaging platform and the recently approved reconstrainable deployment system of this EVAR device allowed us to safely treat an elderly Wisconsin woman with a minimally invasive approach. We used the unique ability to deploy an EVAR device, reconstrain and then redeploy twice in today's complex case to increase our placement accuracy beyond what would have been possible with a single deployment."

The GORE^® EXCLUDER^® Device is unchanged, maintaining the same low delivery profile and flexibility on catheter that facilitates access and passage through narrow and tortuous anatomies. Once delivered into the aorta, the GORE^® C3 Delivery System uniquely and intuitively enables repositioning of the stent-graft during the procedure. The ability to reposition the device may minimize complications that could occur if the graft needs to be repositioned after the initial deployment. This revolutionary technology was designed to give physicians a second or third opportunity to accurately place the stent-graft relative to the patient's anatomy.

A SINGLE-CENTER EXPERIENCE COMPARING TIBIAL BYPASS WITH HEPARIN-BONDED ePTFE VERSUS SAPHENOUS VEIN

Richard Neville, MD, of The George Washington University, presented his data on the GORE^® PROPATEN^® Vascular Graft (Heparin-Bonded ePTFE) compared to suitable quality, greater saphenous vein (SVG) for tibial bypass at the Southern Association for Vascular Surgery (SAVS) Annual Meeting in January. A retrospective analysis of prospectively collected data was conducted for 112 tibial bypasses performed from November 2006 to January 2009, including 62 GORE^® PROPATEN^® Vascular Graft and 50 SVG. Patient demographics were similar between the two groups with respect to age, sex (65% male), race (44% white, 52% African-American (AA)), Diabetes Mellitus (DM) (57%), and End-Stage Renal Disease (ESRD) (15%). Indications for revascularization were similar; claudication 9%, rest pain 25%, and tissue loss 66%. The GORE^® PROPATEN^® Vascular Graft group included significantly more re-operative procedures (44% vs 18%, p= 0.016). Post-operative graft surveillance by pulse exam, Ankle Brachial Index (ABI), and Duplex ultrasound was at 1, 3, 6, and 12 months. The follow-up period ranged from 1 to 12 months with Kaplan-Meier and Cox regression analysis used to evaluate results in those patients with all variables non-missing.

At one year, primary patency for GORE^® PROPATEN^® Vascular Graft was 75%, and SVG patency was 86% (p = 0.1785). Thirty-seven patients had a secondary procedure (33%); 23 GORE^® PROPATEN^® Vascular Graft, 14 SVG. Significant factors related to a second procedure included age and ESRD. There were 16 amputations (14%) with a mean time to amputation of 4.9 months. There was no difference based on conduit; 9 GORE^® PROPATEN^® Vascular Graft, 7 SVG. Furthermore, GORE^® PROPATEN^® Vascular Graft and SVG bypasses demonstrated no difference in target artery among anterior tibial, posterior tibial, dorsalis pedis, and peroneal. Venous conduit was absent in the GORE^® PROPATEN^® Vascular Graft group due to prior bypass (32%), coronary artery bypass graft (CABG) (29%), vein stripping (12%), or poor quality vein (27%). Nineteen patients (18.6%) suffered graft occlusion or death during follow-up. There was no significant difference in primary patency due to gender (male 78% vs female 84%), race (white 82%, AA 77%), or diabetes (non-DM 84%, DM 76%). ESRD resulted in decreased patency (57%) with an eightfold reduction (95% CI 1.8-39.8). Patency was highest for claudicants (95%) with rest pain (81%), gangrene (71%), and ulcer (72%) decreased, respectively.

Dr. Neville reported on a single-center, US experience for tibial bypass using GORE^® PROPATEN^® Vascular Graft and SVG over a contemporaneous time period. Factors related to decreased one year patency were ESRD and non-healing ulcer. A trend toward superiority for a single segment, suitable quality, greater saphenous vein over GORE^® PROPATEN^® Vascular Graft as a conduit for tibial bypass was observed. However, the difference did not reach statistical significance. There was no difference in limb salvage based on the bypass conduit employed. Dr. Neville stated, that for tibial bypass, based on his experience with the GORE^® PROPATEN^® Vascular Graft combined with available data, he "justifies the use of GORE^® PROPATEN^® Vascular Graft when quality, greater saphenous vein is not available."

LIVE CASES HIGHLIGHT INNOVATION IN GORE AORTIC PORTFOLIO

At the recent LINC congress in Leipzig Germany and at the ISET meeting in Miami, Florida, attendees were able to observe the latest innovations from Gore in action. Live cases were performed using the GORE^® TAG^® Thoracic Endoprosthesis with enhanced conformable design, GORE^® EXCLUDER^® AAA Endoprosthesis featuring C3 Delivery System and the GORE^® DrySeal Sheath.

At ISET, Barry T. Katzen, MD, performed the first US live broadcast of an EVAR procedure using the novel GORE^® C3 Delivery System. Dr. Katzen performed the procedure with assistance from Ripal Gandhi, MD, and Michael Nguyen, MD. The entire procedure was done percutaneously and achieved full exclusion of the aneurysm. Dr. Katzen reported, "The new GORE^® C3 Delivery System tracked easily through some tortuosity of the iliacs and deployed with great accuracy. We did reposition the GORE^® EXCLUDER^® Device to improve its position in relation to the renals, and found it very easy to constrain, move and then release in a controlled manner at the ideal location."

Minutes later, Piotr M. Kasprzak, MD, performed the first European live broadcast of the treatment of an abdominal aortic aneurysm utilizing the GORE^® EXCLUDER^® Device featuring C3 Delivery System. Dr. Kasprzak described the anatomy as moderate with a longer straight neck, though after initial deployment, the repositionability of the system enabled Dr. Kasprzak to improve positioning. "The GORE^® C3 Delivery System is a significant advance for EVAR. Two important points should be stressed regarding our case. First, we were able to easily reposition the GORE^® EXCLUDER^® Device very close to the renal arteries after primary deployment delivered the stent graft 6 - 7 mm below the renals. And second, we were able to correct the rotation of the device to ease cannulation, even in the long neck."

Another live case was performed at the LINC meeting, although this one utilized the GORE^® TAG^® Device with enhanced conformable design, which received CE mark in October 2009 and is only currently available in the US within a pivotal FDA trial. Dierk Scheinert, MD, performed the case on a 77 year-old male in Leipzig. The patient was treated for a Type B thoracic aortic dissection. The GORE^® TAG^® Device with enhanced conformable design deployed with excellent accuracy and adapted beautifully to the curvature of the thoracic aorta providing a positive outcome for the patient.

A unique aspect of all three of the live cases was the reduced amount of blood lost through the sheath through which all three devices were delivered. This was because all three cases utilized the advanced hemostasis technology of the GORE^® DrySeal Sheath. This new sheath from Gore uses a pressurized ePTFE / silicone valve technology to effectively minimize blood loss for the patient while enabling multiple devices to pass through the valve.

With exposure to the large audiences at ISET and LINC, Gore is experiencing an increased demand for these new advances in endovascular aortic therapy. Check with your local Gore sales associate for availability of these products.

REVASCULARIZATION OF THE RIGHT COMMON ILIAC ARTERY TO ESTABLISH INFLOW TO A RIGHT-TO-LEFT FEMORAL-TO-FEMORAL BYPASS GRAFT USING A GORE^® VIABAHN^® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

Patrick E. Muck, MD
Bethesda North Hospital, Cincinnati, Ohio

	Clinical Challenge The patient is a 71-year-old man with a disabling bilateral lower extremity claudication. Previously, the patient had undergone a right-to-left, femoral-to-femoral artery bypass with a GORE® PROPATEN® Vascular Graft. Arterial duplex indicated a patent fem-fem bypass graft, with ankle brachial indices (ABI) of 0.73 on the right and 0.69 on the left (Figure 1a). Computerized tomography angiography (CTA) revealed a patent graft but a high-grade irregular stenosis of the right common iliac artery (Figure 1b).
	Patient The patient underwent angiography via the right common femoral artery. Aortogram showed an 80% right common iliac artery stenosis. The bilateral common femoral, profunda and superficial femoral arteries were patent. The right-to-left fem-fem bypass graft was patent. The patient received percutaneous transluminal angioplasty (PTA), and there was a significant residual common iliac artery stenosis. An 8 mm x 5 cm GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface was inserted into the right common iliac artery. This was followed by post-dilation with a balloon, resulting in good flow through the common iliac artery (Figures 2a and 2b).
	Results Completion angiogram revealed a widely patent right common iliac artery. At his two-week follow-up, the patient had complete resolution of his claudication symptoms. On exam, the patient had strong pedal pulses and ABIs were normal bilaterally.
	Physician Comments The GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface offers the unique combination of flexibility and adequate radial force to treat iliac lesions. The use of this device may offer a better solution than bare metal stenting which sometimes is associated with intimal hyperplasia and in-stent restenosis.

GORE ANNOUNCES LAUNCH OF NEXT EVOLUTION OF GORE^® VIABAHN^® ENDOPROSTHESIS

Lower Profile Delivery System in US Provides More Options for Endoluminal Bypass

Gore has received approval for distribution of the GORE^® VIABAHN^® Endoprosthesis with Heparin Bioactive Surface on a lower profile delivery system in the US, Europe and Australia. The GORE^® VIABAHN^® Device is designed to percutaneously treat peripheral artery disease by relining the native vessel. This next generation device enables a reduction in delivery profile to 6 Fr for 5 and 6 mm devices and 7 Fr for 7 and 8 mm devices. These devices are delivered over a 0.014" or 0.018" guidewire. No changes have been made to the endoprosthesis. The reduced delivery profile will provide interventionalists with greater options for delivery with the same trackability and device performance in treating stenoses and occlusions of the Superficial Femoral Artery (SFA) and Iliac Artery.

"While most technology has stagnated over the past several years, Gore continues to optimize the GORE^® VIABAHN^® Endoprosthesis, which allows physicians to broaden the potential patient population that we can treat," said Gary Ansel, MD, Interventional Cardiologist at Riverside Methodist Hospital, Columbus, Ohio.

The new device is available with a 120 cm long delivery catheter and incorporates the CARMEDA^® BioActive Surface (CBAS^® Surface), which utilizes end-point immobilization of derivatized heparin to the luminal surface of the endoprosthesis. This proprietary CBAS^® Surface technology preserves the heparin bioactive sites such that they remain free to interact with the blood at the device surface without being consumed.

"The reduction in profile of the GORE^® VIABAHN^® Endoprosthesis means easier endovascular delivery of the device to treat occlusions in the SFA and other tough to reach locations in patients where a small access size is critical and includes all of the historical benefits of Heparin-Bonded Bioactive Surface," said Daniele Savio, MD, Vascular and Interventional Radiology, San Giovanni Bosco Hospital, Torino, Italy.

"Several clinical implants have been successfully completed in both Europe and the US and the feedback from physicians has been extremely positive. With all the new advancements to the GORE^® VIABAHN^® Endoprosthesis over the last 15 years, we are pleased, once again, to be able to expand our offering with the launch of this new lower profile delivery system," said Erin Hutchinson, Gore Peripheral Vascular Business.

GORE CONTINUES TO CHANGE PARADIGMS OF AORTIC CASE PLANNING WITH NEW GORE^® 3D IMAGING SYSTEM

"You cannot fix what you cannot see," and "Proper Planning Prevents Poor Performance" are old adages, which when combined, articulate the need for accurate pre-case imaging for endovascular repair of the aorta. Now clinicians have an additional tool from Gore to meet this need - the GORE^® 3D Imaging System.

Gore has worked over the last year in a partnership with TeraRecon^® to broaden the power of TeraRecon's award-winning iNtuition application software, by employing a new, secure DICOM image upload technology that delivers unmatched ease of use, reliability and responsiveness. This is a significant step forward for physicians and clinicians who need rapid access to 3D planning tools that aid in proper planning for patient treatment.

"Ease-of-use and speed are the essential aspects of this new system," says David Abeyta, Gore Aortic Business, "both aspects are driven by a small file transfer program installed on either the clinician's or the institution's computer."

The clinician or staff member simply 'drags and drops' CT image files to this transfer program, which sends the images through a secure internet connection to a secure, cloud-based server that creates a 3D reconstruction of the patient's anatomy from the CT images. A clinically trained Gore associate can then access the reconstruction on the secure server from any internet connection to verify initial measurements and support the preparation of a case plan for the physician.

The clinician can review the 3D images and measurements with the Gore associate in person, over the phone, or via web conferencing. Modifications can be made and additional images generated with a few clicks of the mouse. The end result is a reduction in both interpretation turn-around times and potential case planning delays.

Simple as drag-and-drop, the GORE^® 3D Imaging System is simple, efficient and provides clear results. For more information contact your local Gore endovascular sales associate or visit goremedical.com/3D.