Assurant Cobalt Iliac BALLOON EXPANDABLE STENT SYSTEM

Transcription

1 Assurant Cobalt Iliac BALLOON EXPANDABLE STENT SYSTEM Innovating for life.

2 CONFORMABILIT Y 6 F S H E AT H C O M PAT I B I L I T Y THE ASSURANT COBALT ILIAC STENT, WITH ITS UNIQUE COBALT CHROMIUM MODULAR DESIGN, PROVIDES EXCELLENT CONFORMABILITY WITHOUT SACRIFICING RADIAL STRENGTH. * Allows for immediate postprocedure MRI imaging (MRI conditional) Greater conformability* Excellent radial strength* By combining its unique cobalt chromium modular design with our patented Secure Technology, Assurant Cobalt Iliac achieves sheath compatibility for every stent size.* sheath compatibility for every stent size Sheath Compatibility Matrix Modular design for providing radial strength with conformability EXPRESS LD Omnilink Elite ASSURANT COBALT ILIAC Increasing Radial Force Radial Force (Compression Force) (N/mm).3 Assurant Cobalt Iliac Express LD Omnilink Elite 7F 7F Lower Crossing Profile design makes the stent extremely trackable.** Increasing Conformability Stent Conformability (Post-Deployment) (N) Smaller Consistent Cell Size* is designed to conform to the vessel wall..8 Medtronic Assurant Cobalt Iliac (8 mm x 6 mm) Medtronic Assurant Cobalt Iliac (8 mm x 6 mm).87 Boston Scientific Express LD (8 mm x 57 mm).85 Abbott Omnilink Elite (8 mm x 59 mm) Boston Scientific Express LD (8 mm x 57 mm) *Bench data on file at Medtronic, Inc., compares the Assurant Cobalt Iliac stent with the Boston Scientific Express LD stent and Abbott Omnilink Elite stent. Bench test results may not be indicative of clinical performance. Cell area bench test was not performed for Abbott Omnilink Elite. *Boston Scientific Express LD IFU and Abbott Omnilink Elite IFU **Bench data on file at Medtronic, Inc., compares the Assurant Cobalt Iliac stent with the Boston Scientific Express LD stent and Abbott Omnilink Elite stent. Bench test results may not be indicative of clinical performance.

3 C L I N I C A L R E S U LT S ACTIVE US CLINICAL TRIAL 9-MONTH FOLLOW-UP IMPROVEMENT IN CLINICAL STATUS, ABI AND WALKING CAPACITY ACTIVE US Clinical Trial Overview Fontaine Class Trial Design Prospective, multicenter, non-randomized Primary Endpoint Major adverse events at s Secondary Endpoints Primary Patency, Acute Success, Clinical Success, ABI, and Capacity at s Number of Subjects 123 subjects with symptomatic PAD Lesions (Procedural) Direct Stenting () 46.8 Mean lesion length ± Post Proc. Stenosis ( ± SD) ± 6.99 Stenosis (most severe) ± Post Procedure MLD (mm ± SD) MLD Primary Endpoint Shows Low MAE Rates Major Adverse Event (MAE) rates include target lesion revascularization (TLR), target vessel revascularization (TVR), target limb loss, and death, including both device-related and procedure-related. During the ACTIVE Trial, one of 123 subjects received a TVR/TLR (.8). No death or target limb loss occurred in the study, thus the composite 9-month MAE is m MAE Death total (device and proc. related)..8.8 Target limb loss TLR TVR * 53.6* (11) (14/141) (119/123) 9-m MAE Death Target TLR total (device and limb loss proc. related) (132/146) TVR (14/141) (119/123) 9.4 (132/146) (/121) Primary patency rate1 Device success2 Lesion success3 Procedural success4 Clinical success5 2 All cause mortality. (/121) Primary patency rate1 Device success2 Lesion success3 Procedural success4 Clinical success5 61.7* Stair impairment distance speed climbing ABI Distribution.6 Cumulative Frequency. I IIa IIb III (N = 147) ACTIVE Data Show Increased Capacity Secondary Endpoints Show 99.3 Primary Patency * (19) Days (122) Months 71.4 (N = 157) All cause mortality 1. I n the ACTIVE study, Primary Patency is reported as 1. It is defined as the blood flow through the treated vessel segment into the distal vasculature (e.g. the common femoral artery and/or the deep femoral artery) as evidenced by duplex ultrasound scan at 3 days and at s for all subjects enrolled with evaluable Duplex scans. Primary patency as defined in this study is independent of interval revascularization procedure. The study definition did not include TLR or TVR. Including TLR and TVR in primary patency calculation yields a primary patency rate of Device success defined as angiographic evidence of <3 final residual stenosis of the target lesion using only the assigned device. 3. Lesion success defined as angiographic evidence of <3 final residual stenosis of the target lesion using any percutaneous method. 4. Procedure success defined as angiographic evidence of <3 final residual stenosis of the target lesion after stent placement and no occurrence of a procedure-related MAE prior to hospital discharge (for subjects with more than one lesion stented the worse case is counted). 5. Clinical success defined as the improvement of Fontaine classification by at least one stage above the pretreated (pre-procedure) clinical value. Assessment, () (N = 147) ABI ± ± (N = 157) Assessment, () of Limbs of Patients 7.62 ± 1.18 I IIa IIb III 4 2 Lesions () Characteristics RVD 79 8 of Patients * * (11) impairment 22.9 distance 45.6* (19) 22.7 speed 61.7* 31.8 (122) Stair climbing All values are mean (n). The walking impairment questionnaire (WIQ) scores range from (unable to perform due to severe claudication) to 1 (no impairment). *P value (baseline vs 9-m) <.1

4 UNIQUE MODULAR DESIGN PROVIDES GREATER CONFORMABILITY The Assurant Cobalt Iliac stent s modular design starts with an advanced cobalt chromium alloy, which is used to create individual rings that are then formed into sinusoidal elements. These elements are laser-fused using customized fusion patterns specifically designed to provide an optimal balance of strength and conformability, then electropolished to create a smooth, edgeless finish. Our patented Secure Technology stent retention system features distal and proximal pillows intended to secure the stent to the catheter during delivery. Indications: The Assurant Cobalt Iliac Balloon-Expandable Stent System is indicated for improving iliac luminal diameter in patients with de novo and restenotic lesions in the common and external iliac arteries with reference vessel diameters between 6mm and 1mm and lesion lengths up to 61mm. The stent is intended as a permanent implant. Contraindications: There are no known contraindications. Warnings and Precautions: The Assurant Cobalt Iliac Balloon-Expandable Stent System is provided sterile for single use only. Do not reuse, reprocess, or resterilize this product. Reuse, reprocessing, or resterilization may compromise the mechanical/structural integrity of the device, compromise the essential material and design characteristics of the device, and/or create a risk of contamination of the device, which could result in patient injury, illness, or death. Do not modify the packaging or labeling as this may lead to the use of an incorrect or expired product, which could result in patient injury or death. Use prior to the Use By date noted on the package. Patients allergic to cobalt-chromium alloy may suffer an allergic reaction to this implant. Administration of appropriate anticoagulant therapy and/or antiplatelet therapy is critical to the success of the procedure. When multiple stents are required and placement may result in overlap or stent-to-stent contact, stent materials should be of similar composition to avoid the potential for dissimilar metal corrosion. Use only appropriate balloon-inflation media. Do not use air or gas to inflate the balloon as it may cause uneven expansion and stent deployment difficulties. Subsequent restenosis may require repeat dilatation of the arterial segment containing the stent. The long-term outcome following repeat dilatation of endothelialized iliac stents is unknown at present. Caution: Read all the instructions carefully in the Instructions for Use. Failure to properly follow the instructions, warnings, and precautions may lead to serious consequences or injury to the patient. Use of the Assurant Cobalt Iliac Balloon-Expandable Stent System requires advanced iliac angioplasty technical skills. The following instructions will provide technical guidance but do not obviate the need for adequate training prior to use of the device. Stent placement should only be performed at hospitals where emergency surgery can be performed. Do not prepare or preinflate the stent delivery balloon prior to stent deployment other than as directed in these Instructions for Use. If the position of the stent is not optimal or appropriate for the vessel, it should not be deployed. The stent cannot be repositioned once deployed. Prior to stent deployment, utilize high resolution fluoroscopy to verify that the stent has not been damaged or dislodged during positioning. The Assurant Cobalt Iliac Balloon-Expandable Stent System is designed for use as a unit. The stent must not be removed from the delivery system. The Assurant Cobalt stent is not designed to be crimped onto another delivery system. Special care must be taken not to handle or in any way disrupt the stent position on the delivery system balloon. Removing the stent from its delivery system or excessively manipulating the stent (eg, rolling the mounted stent) may cause dislodgement, damage to the stent, and stent embolization. Once deployment is initiated, the stent cannot be removed. Prior to completion of the procedure, utilize fluoroscopy to ensure proper positioning of the deployed stent. If the target lesion is not completely stented, use additional Assurant Cobalt Iliac stents as necessary to adequately treat the lesion. Use caution when crossing the stented area with ancillary equipment to avoid dislodgment of the stent. Judicious selection of patients is necessary since the use of this device carries the associated risk of subacute thrombosis, vascular complications, and bleeding events. The Assurant Cobalt Iliac Balloon-Expandable Stent System does not provide for distal contrast injections or pressure measurements through the guidewire lumen. Stent retrieval methods (use of additional wires, snares, or forceps) may result in additional trauma to the vascular access site. Complications may include bleeding, hematoma, or pseudoaneurysm. MRI Safety and Compatibility: The Assurant Cobalt Iliac stent was determined to be MR conditional. It can be scanned safely in both 1.5T & 3.T MR systems under certain conditions as described in the product Instructions for Use. For additional information regarding MR conditions of use, please refer to the product Instructions for Use. Adverse Events: Potential adverse events include (not arranged in any particular order): acute myocardial infarction, allergic reaction, aneurysm, pseudoaneurysm, arteriovenous fistula, angina, arrhythmias, bleeding complications, death, detachment and/or implantation of a component of the system, embolization, emergent or urgent surgery, fever, hematoma or hemorrhagic event, hypotension or hypertension, infection, ischemia, pain at catheter insertion site, pulmonary embolism, renal failure, restenosis, stent malapposition or migration, stent fracture, stent thrombosis, stroke (CVA or TIA), limb loss, vessel dissection, vascular thrombosis or occlusion at puncture site, treatment site, or remote site, vessel spasm, worsening claudication or rest pain. Please reference product Instructions for Use for more information regarding all adverse events. Caution Federal law (USA) restricts this device for sale by or on order of a physician. FDA approved by PMA1111. Assurant Cobalt Iliac balloon-expandable stent system is a registered trademark of Medtronic, Inc. Trademarks are the property of their respective owners.

5 Order Information Assurant Cobalt Iliac Product Code ASC 6 2 SV Catheter Working Length (SV = 8cm, LV = 13cm) Stent Length Stent Product Code Proximal and distal radiopaque markers Stent Minimum Sheath Size (F) Stent Length ASC62SV ASC62LV ASC63SV ASC63LV ASC64SV ASC66SV 7 6 ASC72SV ASC72LV ASC73SV ASC73LV ASC74SV ASC76SV 8 6 ASC82SV ASC82LV ASC83SV ASC83LV ASC84SV ASC86SV 9 6 ASC93SV ASC93LV ASC94SV ASC96SV 1 6 ASC13SV ASC13LV ASC14SV ASC16SV 8cm catheter working length 13cm catheter working length Bilumen shaft Over-the-wire catheter DEPLOYED CONFIGURATIONS ** Nominal Nominal Stent Length Deployed length at nominal pressure Deployed diameter at nominal pressure Assurant Cobalt ILIAC Compliance Pressure **Data on file at Medtronic, Inc. Medtronic Vascular, Inc Unocal Place Santa Rosa, CA 9543 USA Product Services Support Center Tel: Fax: Deployed Stent I.D. (kpa) (atm) Nominal pressure Rated burst pressure The Assurant Cobalt Iliac balloon-expandable stent system is compatible with a maximum guidewire of.35 in. CardioVascular LifeLine Customer Support Tel: Tel: UC212144b EN 213 Medtronic, Inc. All rights reserved. Printed in USA. For distribution in the USA only. 3/13