Cordis ExoSEal
1 / 12ページ

Cordis ExoSeal Vascular Closure Device Products Providing a broad range of quality and innovative products to make a real difference in the minimally invasive treatment of cardiac and vascular disease. Services Supporting interventionalists and cathlab personnel by offering a full range of educational services through the Cordis Cardiac and Vascular Institute (CCVI). Outcomes Changing the lives of patients by being committed to evidence based medicine with the largest body of clinical evidence. This means maintaining an unwavering commitment to helping change the face of circulatory disease management. Today, tomorrow and into the future, we’re devoted to our strong partnership with you, while consistently creating leading-edge products that will benefit the industry. Maximise Clinical Safety*. The novel approach to secure and easy closure. * Clinical data from the “ECLIPSE Trial” indicates safety in terms of vascular injury, access site-related bleeding, infection or nerve injury, new ipsilateral lower extremity ischemia or SAE. Wong et al JACC Cardiovasc Interv. 2009 Aug;2(8):785-93. Important Information: Prior to use, refer to the “instructions for use” supplied with these devices for indications, contraindications, side effects, suggested procedure, warnings and precautions. As part of the Cordis policy of continuous product development we reserve the right to change product specifications without prior notification. Tel:+32 2 746 30 00 Fax:+32 2 746 34 05 © Johnson & Johnson Medical NV/SA 2013 - August 2013 - 2E-800-1697-4 Wong et al JACC Cardiovasc Interv. 2009 Aug;2(8):785-93. E. injury, new ipsilateral lower extremity ischemia or SA of vascular injury, access site-related bleeding, infection or nerve *Clinical data from the “ECLIPSE Trial” indicates safety in terms Excellent Clinical Results* Precise Extravascular Closure Trusted Bioabsorbable Technology Easy-to-Use Functionality For clinically safe*, confident close resulting in improved patient outcomes, use the Cordis EXOSEAL® Vascular Closure Device Vascular Closure Device

Access, Diagnose and Treat with the Complete Line of Products and Services from Cordis Since 1959, Cordis has been a leader in the market offering best-in-class access, diagnostic and treatment solutions. Over the past four decades, our product offering has grown to become one of the largest in the industry. With high performing solutions to help support sustained patient outcomes, Cordis has become the full-line partner of choice.

Combining clinical safety* and ease-of-use, the Cordis EXOSEAL® Vascular Closure Device means a more confident close and improved patient outcomes. Easy-to-Use Functionality Trusted Bioabsorbable Technology Precise Extravascular Closure Excellent Clinical Results* *Clinical data from the “ECLIPSE Trial” indicates safety in terms of vascular injury, access site-related bleeding, infection or nerve injury, new ipsilateral lower extremity ischemia or SAE. Wong et al JACC Cardiovasc Interv. 2009 Aug;2(8):785-93. Introducing the Cordis EXOSEAL® Vascular Closure De

Product Features Deployment Button Lockout feature reduces risk of intravascular plug deployment. Indicator Window Provides indication of extravascular position before deployment. Sheath Adapter & Wire Loop Release • ompatible with introducer sheath (sheath C . exchange not required)** • Minimises chance of infection and > inflammation — Maximises patient comfort. EXOSEAL® Closure Device provides **Compatible with sheaths up to 12 cm. Please consult IFU for further deta

Cordis EXOSEAL® Vascular Closure Device Maximise Clinical Safety* in Closure Designed for accurate placement, secure extravascular deployment and reduced complication rates.* Bleed-Back System Provides visual indicator for secure extravascular plug deployment. PRODUCT FEATURES Indicator Wire Nitinol indicator wire provides gentle and precise feedback to ensure extravascular plug placement. precise and secure extravascular arterial closure. *Clinical data from the “ECLIPSE Trial” indicates safety in terms of vascular injury, access site-related bleeding, infection or nerve injury, new...

Bioabsorbable Technology Trusted, Synthetic Plug Closure The Cordis EXOSEAL® Vascular Closure Device uses a Polyglycolic Acid (PGA) plug material to securely close the femoral artery puncture site while causing low tissue reactivity to minimise access site complications* . *Clinical data from the “ECLIPSE Trial” indicates safety in terms of vascular injury, access site-related bleeding, infection or nerve injury, new ipsilateral lower extremity ischemia or SAE. Wong et al JACC Cardiovasc Interv. 2009 Aug;2(8):785-9

Plug Absorption Characteristics PGA plug material absorption and tissue reaction assessment in rat gluteal model1 Effective • PGA has a long history in medical use • PGA is not made from animal tissue • Fully resorbed within 60-90 days Data on file at Cordis *Clinical data from the “ECLIPSE Trial” indicates safety in terms of vascular injury, access site-related bleeding, infection or nerve injury, new ipsilateral lower extremity ischemia or SAE. Wong et al JACC Cardiovasc Interv. 2009 Aug;2(8):785-93.

Extravascular Positioning • Confident, extravascular positioning of bioabsorbable plug • Plug is held securely in place by surrounding tissue

Secure and Precise Extravascular Placement • Eliminates any possibility of intravascular deployment • Deploys haemostatic plug without impeding arterial blood flow • Provides two visual signals to increase operator confidence and patient comfort BLACK-WHITE Device not yet positioned to deploy. Lockout feature activated. BLACK-BLACK Deploy, if significantly reduced bleed-back is also seen from bleed-back window. BLACK-RED Release slight tension on device until window shows Black-Black. Otherwise switch to manual compression. EXTRAVASCU