1 Integrity coronary stent system Feeling Is Believing Integrity BMS A Revolution in Stent Engineering The Integrity stent is a single strand of cobalt chromium alloy shaped into a continuous sinusoid setting a new standard in coronary stent innovation Continuous range of motion continuous bending results from the stent's single-wire design and the fusion pattern that follows the wire's pitch Optimal deliverability The MicroTrac delivery system features an integrated tip design, softer Fulcrum balloon, low-profile exchange joint and swaged marker bands The Integrity stent's unique design allows for continual flex, which is not possible in laser-cut stents Integrity Multi-link Vision . constrained by u-joint design Superior Deliverability vs. Multi-link Vision and VeriFlex (Libert )1. Improved Deliverability with a Continuous Range of Motion 100.
2 Deliverability in a 3D Model: BMS. 80. Average Peak Force (g/f ). 77 74. Lower Is Better 60. 40 41. 20. 0. Integrity Multi-link VeriFlex Vision (Libert ). Impressive Structural Performance2. Excellent Radial Strength ( BMS). 1400. Ultimate Crush Pressure (mmHg). 1200 1096 1095. Higher Is Better 1000 946. 800. 600. 400. 200. 0. Integrity Multi-link VeriFlex Maximum clinically Vision (Libert ) relevant pressure 80 160 mmHg3. Bench test data vs. Abbott Multi-link Vision and Boston Scientific VeriFlex (Libert ) coronary stents on file at Medtronic , Inc. Bench test data may not be indicative of clinical performance. 1. Data on file at Medtronic , Inc. 2. O'Brien E et al. Twenty-four-hour ambulatory blood pressure in men and women aged 17 to 80 years: the Allied Irish Bank. J ;9(4):355-360. 3. Integrity Ordering Information Indicate RX (UX) or OTW (W).
3 Stent Stent Length (mm). Diameter (mm) 8 9 12 14 15 18 22 26 30. INT22508UX/w INT22512UX/w INT22514UX/w INT22518UX/w INT22522UX/w INT22526UX/w . INT25008UX/w INT25012UX/w INT25014UX/w INT25018UX/w INT25022UX/w INT25026UX/w . INT27508UX/w INT27512UX/w INT27514UX/w INT27518UX/w INT27522UX/w INT27526UX/w . INT30009UX/w INT30012UX/w INT30015UX/w INT30018UX/w INT30022UX/w INT30026UX/w INT30030UX/w INT35009UX/w INT35012UX/w INT35015UX/w INT35018UX/w INT35022UX/w INT35026UX/w INT35030UX/w INT40009UX/w INT40012UX/w INT40015UX/w INT40018UX/w INT40022UX/w INT40026UX/w INT40030UX/w Integrity Compliance Stent Diameter Pressure Deployed Stent (mm). (atm).. 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 . Nominal pressure Rated burst pressure* Do not postdilate the stents to greater than mm.. Do not postdilate the stents to greater than mm. Test data on file at Medtronic , Inc.
4 Rated burst pressure do not exceed. *. Indications for Use within this instructional material. Judicious selection of patients is necessary The Integrity Coronary Stent Systems are The Integrity Coronary Stent Systems do not since the use of this device carries the indicated for improving coronary luminal provide for distal dye injections or pressure associated risk of subacute thrombosis, Integrity Product Code diameter in patients with symptomatic measurements through the guidewire lumen. vascular complications and/or bleeding ischemic heart disease due to discrete de novo Expansion of the stent should not be events. Administration of appropriate I N T30018UX /W or restenotic lesions with reference vessel anticoagulant, antiplatelet and coronary For distribution in the USA only. 2010 Medtronic , Inc. All rights reserved. Printed in USA.
5 UC201003982EN 9/10. undertaken if the stent is not appropriately diameters of mm and 30 mm in positioned in the vessel. If the position of vasodilator therapy is critical to successful length using direct stenting or predilatation. the stent is not optimal, it should not be stent implantation and follow-up. Over-the-Wire (W) Contraindications expanded. Subsequent restenosis may require repeat Patients in whom antiplatelet and/or Incomplete deployment of the stent dilatation of the arterial segment containing Rapid Exchange (UX) anticoagulation therapy is contraindicated ( , stent not fully expanded) may cause the stent. The long-term outcome following Length Patients who are judged to have a lesion that procedural complications resulting in patient repeat dilatation of endothelialized coronary prevents complete inflation of an angioplasty injury.
6 Stents is unknown at present. Diameter balloon or proper placement of a stent or Advancement of an Integrity Coronary Stent Potential Adverse Events Product Code stent delivery system System through a previously stented segment The following complications may be All other brand names, product names or trademarks belong to their respective holders. Warnings/Precautions may cause procedural complications resulting associated with the use of coronary stenting The long-term effects of stents and the risks in patient injury. devices or PTCA: associated with lifelong carrying of these Placement of the stent has the potential to Acute myocardial infarction Allergic implants are unknown. This lack of knowledge compromise sidebranch patency. reaction to contrast medium/stent material/. should be considered in making a risk/ Administer appropriate anticoagulant/ medications Arrhythmias (including For technical questions, please contact your local sales antiplatelet and coronary artery vasodilator ventricular fibrillation and ventricular benefit assessment for the patient prior to representative or e-mail implantation.)
7 Therapy according to current medical tachycardia) Arteriovenous fistula Bleeding The Integrity Coronary Stent Systems are guidelines and manufacturer's instructions. complications Cardiac tamponade . provided sterile, for one procedure only. Do Caution must be taken when using ancillary Cerebrovascular accident/stroke Death . not resterilize. Use by the Use by date noted equipment, such as intravascular ultrasound Dissection of coronary artery Drug reactions on the package. catheters, to avoid dislodgement or Embolization (air, stent, tissue or thrombotic). Only physicians who have received deformation of the stent. Emergency coronary artery bypass graft appropriate training should perform When multiple stents are required, stent surgery (CABG) Endocarditis Failure to deliver implantation of the stent. Use of an Integrity materials should be of similar composition.
8 The stent Stent deformation, collapse or Coronary Stent System requires advanced Placing multiple stents of different materials fracture Hematoma Hemorrhage requiring coronary angioplasty technical skills. The instructions will give technical guidance, but in contact with each other may increase the potential for corrosion. Data obtained from transfusion Injury of the coronary artery . Myocardial ischemia/infarction Pain and do not obviate the need for formal training in in vitro corrosion tests using a cobalt alloy tenderness at the insertion site Perforation . the use of the device. stent ( Medtronic Integrity Coronary Stent) in Peripheral Ischemia Peripheral nerve injury . Medtronic CardioVascular CardioVascular LifeLine Patients allergic to cobalt alloy may suffer an combination with a stainless steel alloy stent Pseudoaneurysm (coronary/femoral/radial).
9 Allergic reaction to this implant. (Boston Scientific Libert Coronary Stent) Pyrogenic reaction Restenosis of the dilated 3576 Unocal Place Customer Support do not suggest an increased risk of in vivo artery or stented segment Sepsis/infection Do not remove the stent from the stent Santa Rosa, CA 95403 Tel: delivery system; the stent cannot be removed corrosion. Short-term hemodynamic deterioration Tel: and placed on another balloon catheter for When using two wires, care should be (hypotension/hypertension) Stent thrombosis USA or occlusion Total occlusion of coronary artery deployment. taken when introducing, torquing and Tel: Do not try to straighten a kinked shaft or removing one or both guidewires to avoid Unstable angina Vascular thrombosis Vessel Product Services hypotube. Straightening a kinked metal shaft entanglement. It is recommended that one dissection/perforation/spasm Tel: may result in breakage of the shaft.
10 If the guidewire be completely withdrawn from Please reference appropriate product device is kinked, it should not be used. the patient before removing any additional Fax: Instructions for Use for a more detailed list Significant amounts of air in the balloon may equipment. of indications, warnings, precautions and cause uneven expansion of the stent and Stent placement should only be performed potential adverse events. difficulty in deployment of the stent. Do not at hospitals where emergency coronary pre-inflate balloon prior to stent deployment. artery bypass graft surgery can be readily CAUTION: Federal (USA) law restricts this Use balloon preparation technique described performed. device to sale by or on the order of a physician.