Talent Thoracic Stent Graft with THE Xcelerant Delivery System. Expanding the Indications for TEVAR

Transcription

1 Talent Thoracic with THE Xcelerant Delivery System Expanding the Indications for TEVAR

2 Talent Thoracic Precise placement 1 Broad patient applicability 1 Excellent clinical outcomes 1, a + Xcelerant Delivery System Highly controlled 8 Improved trackability 9 Simple deployment = Talent Thoracic with Xcelerant Delivery System GREATER control 8 Broader patient access 1 Enhanced deliverability 9

3 TALENT Thoracic with the Xcelerant Delivery System For Medtronic ordering information, contact your Medtronic Field Representative. Proximal Main Sections TB2222C116X TF2424C116X TF2626C116X TF2828C116X TF3030C115X TF3232C115X TF3434C115X TF3636C114X TF3838C114X TF4040C114X TF4242C113X TF4444C113X TF4646C112X Distal Main Sections TW2622C114X TW2824C113X TW3026C113X TW3228C113X TW3430C113X TW3632C112X TW3834C112X TW4036C112X TW4238C111X TW4440C111X TW4642C110X TW4644C110X Proximal Extensions Distal Extensions TAXF2626W50X TAXF2828W49X TAXF3030W48X TAXF3232W48X TAXF3434W48X TAXF3636W46X TAXF3838W46X TAXF4040W46X TAXF4242W54X TAXF4444W54X TAXF4646W52X TAXW2626B50X TAXW2828B49X TAXW3030B48X TAXW3232B48X TAXW3434B48X TAXW3636B46X TAXW3838B46X TAXW4040B46X TAXW4242B54X TAXW4444B54X TAXW4646B52X Indications The Talent TM Thoracic System is intended for the endovascular repair of fusiform aneurysms and saccular aneurysms/penetrating ulcers of the descending thoracic aorta in patients having appropriate anatomy, including: iliac/femoral access vessel morphology that is compatible with vascular access techniques, devices, and/or accessories; non-aneurysmal aortic diameter in the range of mm; and non-aneurysmal aortic proximal and distal neck lengths 20 mm. Contraindications The Talent Thoracic is contraindicated in: Patients who have a condition that threatens to infect the graft. Patients with sensitivities or allergies to the device materials. Warnings and Precautions Read all instructions carefully. Failure to properly follow the instructions, warnings and precautions may lead to serious consequences or injury to the patient. The Talent Thoracic System should only be used by physicians and teams trained in vascular interventional techniques, including training in the use of this device. Specific training expectations are described in the Instructions for Use. Always have a vascular surgery team available during implantation or reintervention procedures in the event that conversion to open surgical repair is necessary. Do not attempt to use the Talent Thoracic with the Xcelerant Delivery System in patients unable to undergo the necessary preoperative and postoperative imaging and implantation studies as described in the Instructions for Use. The Talent Thoracic System is not recommended in patients who cannot tolerate contrast agents necessary for intra-operative and post-operative follow-up imaging. The Talent Thoracic System is not recommended in patients exceeding weight and/or size limits which compromise or prevent the necessary imaging requirements as described in the Instructions for Use. Prior to the procedure, pre-operative planning for access and placement should be performed. Key anatomic elements that may affect successful exclusion of the aneurysm include severe neck angulation, short aortic neck(s) and significant thrombus and/or calcium at the arterial implantation sites. In the presence of anatomical limitations, a longer neck length may be required to obtain adequate sealing and fixation. See Instructions for Use. The use of this device requires administration of radiographic agents. Patients with pre-existing renal insufficiency may have an increased risk of renal failure postoperatively. The safety and effectiveness of this device in the treatment of dissections have not been established. In the first 10 years of clinical experience (OUScommercial and US investigational), there were 39 Medtronic Vascular Product Services 3576 Unocal Place Telephone: Santa Rosa, CA Fax: USA Telephone: reported events of retrograde dissection in patients. Of the 39 reported events, 33 patients had a preexisting aortic dissection. Inappropriate patient selection may contribute to poor device performance. The long-term safety and effectiveness of this implant have not been established. All patients with endovascular aneurysm repair must undergo periodic imaging to evaluate the stent graft and aneurysm size. Significant aneurysm enlargement (> 5 mm), the appearance of a new endoleak, or migration resulting in an inadequate seal zone should prompt further investigation and may indicate the need for additional intervention or surgical conversion. Intervention or conversion to standard open surgical repair following initial endovascular repair should be considered for patients experiencing enlarging aneurysms and/or endoleak. An increase in aneurysm size and/or persistent endoleak may lead to aneurysm rupture. The safety and effectiveness of the Talent Thoracic System have not been evaluated in some patient populations. Please refer to the product Instructions for Use for details. MRI Safety and Compatibility Non-clinical testing has demonstrated that the Talent Thoracic is MR Conditional. It can be scanned safely in both 1.5T & 3.0T MR systems under certain conditions as described in the product Instructions for Use. For additional information regarding MRI please refer to the product Instructions for Use. Adverse Events Potential adverse events include (not arranged in any particular order): Amputation, Aneurysm Enlargement, Balloon rupture, Breakage of the metal portion of the device, Cardiac Failure/Infarction, Change in mental status, Conversion to open surgery, Death, Deployment difficulties, Edema, Embolization, Endoleak, Erectile Dysfunction, Erosion with fistula or pseudoaneurysm, Failure to deploy, Gastrointestinal complications, including: adynamic ileus, bowel (ileus, transient ischemic, infarction, necrosis), Graft twisting and/or kinking, Hemorrhage/Bleeding, Inaccurate placement, Infection and fever, Insertion and removal difficulties, Intercostal pain, Neurological complications, including: spinal cord ischemia with paraplegia, paraparesis and/ or paresthesia, Cerebral Vascular Accidents (CVA), Transient Ischemic Attacks (TIA), neuropathy, and blindness, Prosthetic thrombosis, Pulmonary complications, Renal failure, Rupture of graft material, Ruptured vessel/aneurysm sac enlargement, Stent graft migration, Vascular complications including: thrombosis, thromboembolism, occlusion (arterial and venous), vessel dissection or perforation, collateral vessel occlusion, vascular ischemia, tissue necrosis, amputation, Wound healing complications. Please reference product Instructions for Use for more information regarding indications, warnings, precautions, contraindications and adverse events. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. Notes: a. The Vascular Talent Thoracic System for the Treatment of Thoracic Aortic Aneurysms (VALOR) is a prospective, nonrandomized, 3-armed, multicenter study conducted to evaluate the safety and effectiveness of the Talent Thoracic System when used in low-to-moderate risk patients with thoracic aortic disease (test arm n=195). The primary effectiveness endpoint is successful aneurysm treatment at 12 months. The primary safety endpoint is all-cause mortality at 12 months. Data in this chart is 12 month data unless otherwise noted. b. Successful aneurysm treatment is defined as no aneurysm growth >5 mm at 12-month follow-up when compared to 1-month follow-up visit and absence of a Type I endoleak for which a secondary procedure was performed before, at, or as a result of the 12-month follow-up visit. Of the 14 subjects with a primary effectiveness failure at 12 months, 10 patients had aneurysm growth > 5 mm, 3 patients had a Type I endoleak requiring reintervention, and 1 patient had both aneurysm growth > 5 mm and a Type I endoleak requiring reintervention. c. Successful deployment and delivery of the stent graft at implantation equaled 99.5%. This secondary endpoint is a 30-day endpoint. d. This study was conducted to evaluate various performance characteristics and product attributes of thoracic endovascular stent graft systems used to treat thoracic aortic lesions. Testing was conducted on 34 mm commercially available devices in an air chamber that maintained ambient temperatures at 37 ±2 C. References: 1. Summary of Safety and Effectiveness Data Talent Thoracic System. 2. Lin PH, El Sayed HF, Kougias P, et al. Endovascular repair of thoracic aortic disease: overview of current devices and clinical results. Vascular. 2007;15(4): Medtronic Field Assurance Worldwide Complaints for Talent Thoracic on CoilTrac- January 2002-April 15, 2008 inclusive. 4. Data on file. Medtronic Vascular; Santa Rosa, CA; Kwolek CJ, Fairman R. Update on thoracic aortic endovascular grafting using the Medtronic Talent device. Semin Vasc Surg. 2006;19(1): Data on file, Circumferential compression test. Medtronic Vascular; Santa Rosa, CA; Cook and Gore IFUs. Crossing profile (OD) is lower than Gore TAG in all diameters, and lower than or the same as Cook Zenith TX2 in all diameters except for 34mm stent graft, where Medtronic Talent is 1F size larger than Cook Zenith TX2. Data on file. Medtronic Vascular; Santa Rosa, CA; Data on file, gear ratio test. Medtronic Vascular; Santa Rosa, CA; Data on file, trackability and kink radius test. Medtronic Vascular; Santa Rosa, CA; For distribution in the USA only Medtronic, Inc. All rights reserved. Printed in the USA. Trademarks are the property of their respective owners. UC EN 9/08

4 Treat More Patients The widest range of diameters currently available in the US 1 22 mm to 46 mm diameters with tapered distal main sections Given the wide diameter treatment range, 25% of implanted subjects [in the VALOR Trial] could not have been treated with current commercially available devices. Ronald Fairman, MD, Professor and Chief, Division of Vascular Surgery and Endovascular Therapy, Hospital of the University of Pennsylvania Proximal 5-peak bare spring allows for crossing the LCC or LSA without occluding blood flow 2 Customized for your challenging patient anatomies Tapered distal main Distal bare spring option to avoid covering celiac artery 2 4 mm Taper Closed Web Distal Bare Spring

5 Control Your Deployment for Accurate Delivery Controlled proximal to distal deployment for precise placement 8 with the Xcelerant Delivery System RO markers provide clear landing visibility 1 I found Talent Thoracic on Xcelerant to be highly accurate when deploying in the thoracic arch. It also tracked easily through tortuous iliacs. Karthikeshwar Kasirajan, MD, Assistant Professor of Surgery, Emory University School of Medicine Profile Similar to or Lower than Thoracic Devices Currently Available 7 Medtronic Talent Cook Zenith TX2 Gore TAG Inner : N/A Inner : (20-22F) Inner : (20-24F) Outer : 22-25F Sheath Not Required Outer : 23-25F Sheath Required Outer : 23-27F Sheath Required Easy Three-Step Deployment 1 2 3

6 Excellent Patient Outcomes A decade of worldwide experience No reported collapses in more than 20,000 implants worldwide in the first 6 years of experience 3 Discussed in more peer-reviewed publications than any other thoracic stent graft 4 Pre-operative Angiogram Post-operative Angiogram Courtesy of Ronald Fairman, MD, Professor and Chief, Division of Vascular Surgery and Endovascular Therapy, Hospital of the University of Pennsylvania Impressive clinical data VALOR Pivotal Clinical Data 1,5,a Effectiveness Safety 89.2% Successful aneurysm treatment b 16.1% All-cause mortality 99.5% Successful vessel access and deployment c 3.1% Aneurysm-related mortality 100.0% Patency 0.5% Aneurysm rupture High radial force proven in competitive bench testing 6,d FreeFlo configuration conforms to vessel to help minimize migration 100% patency achieved at 12 months in the VALOR Trial 1 Medtronic Talent Gore TAG Radial Force Comparison 6 Proximal sealing zone Distal sealing zone Body spring Cook Zenith TX Increasing mean LBF* *LBF= pound-force