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The EasyFlow Aortic Cannula is intended for use in the perfusion of the aorta during cardiovascular surgery procedures requiring extracorporeal cardiopulmonary bypass for up to 6 hours. The EasyFlow Duo Cannula with guidewire is intended for use with cardiopulmonary bypass as an arterial return femoral cannula for up to 6 hours.

Easyflow & Easyflow Duo are single-use, non-toxic, non-pyrogenic fluid path devices and supplied sterile and individually packaged. The Easyflow & Easyflow Duo are composed of the cannula and a malleable obturator inserted into the cannula to allow the placement of the cannula along the Artery. The cannula is an open lumen PVC polymer tube incorporating wire reinforcement in distal sections. The distal sections of the cannula are perforated with multiple holes at multiple stages to allow fluid flow. The clear proximal section is not reinforced to allow clamping; the proximal end terminates in a 3/8" barbed connector for standard cardiopulmonary bypass tubing In the Easyflow Duo models the device has a 0.035" hole punched in the very distal tip of the cannula and the obturator has an approx. 0.035" internal diameter central lumen to accommodate a 0.035" guide wire used to drive the cannula along the vessel till its final placement. Once the cannula is positioned onto the vessel the surgeon removes the obturator from the cannula tubing and connects it to the arterial line. The Easyflow is packaged as sterile stand-alone device while the Easyflow Duo is packaged into a tray containing also a Guidewire, a Needle and Vascular Dilators in order to have a kit for vascular access packaged together with the cannula. The Easyflow & Easyflow Duo are the modified version of the disposables currently marketed as the Easyflow cannula (K060101) and the Easyflow Duo cannula (K091542). Both modified and unmodified cannulae models are recommended for use as an arterial return cannula during cardiopulmonary bypass up to six hours

This cannula is intended for use in venous drainage via the right atrium and inferior vena cava simultaneously during cardiopulmonary bypass surgery up to six hours or less.

The MC2™ Two-Stage Venous Cannula and MC2X™ Three-Stage Venous Cannula models feature wire wound polyvinyl chloride (PVC) bodies with side ports in the distal tip, a ported atrial basket drainage site located along the length of the cannula body, and a 3/8-inch (0.95 cm) to 1/2-inch (1.27 cm) connection site. The overall length of each cannula body is approximately 15¼ inch (38.7 cm). Insertion depth marks are provided to aid in positioning of the cannula. Each cannula is nonpyrogenic, is intended for single use, and has been sterilized using ethylene oxide.

The Quantum Perfusion Dual Lumen Cannula is intended for use as a single cannula for both venous drainage and reinfusion of blood via the internal jugular vein during extracorporeal life support procedures for periods of maximum 6 hours.

Quantum Perfusion Dual Lumen Cannula product family are single use devices intended to be used in medical procedures providing cardiac and/or respiratory support up to 6 hours. Devices are characterized by two coaxial catheters and are designed to be coupled with an extracorporeal circuit for artificial oxygenation of the blood and carbon dioxide removal. Devices exploit a single site insertion which reduces the invasiveness of extracorporeal procedures. It can be inserted via a percutaneous approach through the right internal jugular vein. Blood is drained through the lumen of the outer catheter and returned through the lumen of the inner catheter. Devices feature multiple inflow openings in the outer catheter limiting the circulation of unoxygenated blood. Devices are non-toxic, non-pyrogenic, sterilized by ethylene oxide and packaged in a double pouch. All the devices' surfaces in contact with blood are coated with a phosphorylcholine-based biocompatible material.

The Aortic root cannulae are intended for use in adult and pediatric patients to cannulate the aortic root for cardioplegic solution delivery into the coronary arteries and for venting of the heart during cardiopulmonary bypass surgery for periods of up to six hours.

The R501-R502 Aortic Root Cannula (hereinafter referred to as R501-R502 cannulae) are aortic root cannulae intended to be used to cannulate the aortic root, to vent and to deliver cardioplegic solution during heat bypass operations. The device is available in two styles: with a vent line (R502) and without a vent line (R501). Both models consist of a flexible Polyvinylchloride (PVC) tubing body, a PVC flanged tip and luer connector. The introducer is made of stainless steel with a PVC obturator. The vent line model have an additional feature constituted by a vent line provided as integral part of the device. This attribute makes it possible to vent and also introduce cardioplegic solutions using the same device. These cannulae are available in a range of sizes as per table below: | Model | Tip size (internal diameter) | Product designation | |--------------------------------------|------------------------------|---------------------| | R501 (aortic root without vent line) | 1.5 mm | R501-15 | | | 2.0 mm | R501-20 | | | 2.6 mm | R501-26 | | R502 (aortic root with vent line) | 1.5 mm | R502-15 | | | 2.0 mm | R502-20 | | | 2.6 mm | R502-26 | The R501-R502 cannulae are a modified version of the currently marketed R501-R502 Aortic Root cannulae (K200612).

EZ Glide Aortic Perfusion Cannulae: Aortic perfusion cannulae are intended for perfusion of the aorta during short-term (≤6 hours) cardiopulmonary bypass procedures. Aortic perfusion cannulae may be used in pediatric or adult populations based on the flow rate requirements and individual patient anatomy. Please consult labeling to determine pressure drop related to flow rates. OptiSite Arterial Perfusion Cannulae: The Edwards Lifesciences arterial perfusion cannulae are indicated for arterial perfusion in the extracorporeal circuit for < 6 hours. Cannulation site selection is left to the discretion of the surgeon and may include the femoral artery or the aortic arch. EndoReturn Arterial Cannulae: The EndoReturn arterial cannula are indicated for patients undergoing cardiopulmonary bypass. They are intended to deliver oxygenated blood for cardiopulmonary bypass during surgery. The EndoReturn arterial cannula with hemostasis valve also allows the hemostatic introduction and removal of vascular catheters such as the EndoClamp aortic catheter.

EZ Glide Aortic Perfusion Cannulae: The EZ Glide Aortic Perfusion Cannulae device deliver oxygenated blood from the cardiopulmonary bypass pump directly into the aorta. The cannulae terminate in a 3/8" (9.5mm) barbed tubing connector and a vent plug. Cannulae are wire-reinforced and include a dispersion tip in either a straight or curved configuration. EZ Glide Aortic Cannulae are available in sizes 21 French (Fr) and 24 French (Fr). The EZ Glide Aortic Cannulae are packaged sterile and non-pyrogenic in a sealed, peel-type pouch. Note that there are no accessories packaged with the EZ Glide Aortic Perfusion Cannulae. OptiSite Arterial Perfusion Cannulae: The OptiSite Arterial Perfusion Cannulae device is indicated for arterial perfusion in the extracorporeal circuit for less than 6 hours. Cannulation site selection is left to the discretion of the surgeon and may include the femoral artery or the aortic arch. The Edwards Lifesciences Arterial Perfusion Cannulae have smoothly rounded tips to facilitate atraumatic insertion. The proximal ends of the cannula are designed to accept 3/8" (9.5mm) tubing. Introducers are provided with some arterial cannula codes. Introducers are designed for use with 0.038" (0.96 mm) quidewires. Each introducer is provided with a removable vented luer cap. Leave the vented cap in place to allow venting of the cannula for use without a guidewire. Remove the cap to allow cannula use with a guidewire. The OptiSite Arterial Perfusion Cannulae are packaged sterile and non-pyrogenic in a sealed, peel-type pouch. EndoReturn Arterial Cannulae: The EndoReturn Arterial Cannulae devices are flexible plastic tubes intended to provide a means of perfusing arterial blood returning to the patient from the oxygenator through the extracorporeal circuit during cardiopulmonary bypass procedures. The cannulae are placed either through the femoral artery or directly into the aorta to return oxygenated blood from the CPB circuit and to hemostatically introduce Edwards intra-aortic occlusion catheters. Each device is packaged sterile and non-pyrogenic in a sealed, peel-type pouch and are intended and labeled for single use only. The Endo Return Arterial Cannulae with the hemostasis valve are made with a wirereinforced cannula shaft which provides kink resistance and flexibility, and include the following kit components: Introducer, Guidewire (0.038" (0.097mm) x 100 cm) J-tip, Connector hub. The tapered atraumatic tip aids in insertion and advancement into the femoral artery. The non-wire-reinforced clamp site(s), a 3/8 in. barbed connector, and a hemostasis valve allows passage of catheters such as the Edwards IntraClude intra-aortic occlusion device. The introducers accept a 0.038 in. (0.97 mm) quidewire and are marked to simplify assembly. A connector hub secures and immobilizes the introducer within the cannula for easier, oneperson insertion of the cannula/introducer assembly. A lubricious coating, (SlipCoat™) is applied to the surface of the EndoReturn arterial cannula shafts. This coating is intended to provide a lubricious surface effective for the duration of the intended use of the cannula, thereby easing the insertion of the cannula into the artery, and the aortic occlusion catheters through the cannula. The EndoReturn Arterial Cannulae are packaged sterile and nonpyrogenic in a sealed, peel-type pouch.

The DLP™ Silicone Coronary Artery Ostial Cannulae, Models 30315, 30317, and 30320 are intended for use in conjunction with cardiopulmonary bypass surgery up to six hours or less for delivery of cardioplegia solutions directly to the coronary arteries.

The DLP™ Silicone Coronary Artery Ostial Cannulae, Models 30315, 30317, and 30320 feature a soft bulb beveled tip with a silicone body. The Cannulae terminate with a locking female luer fitting. The Cannulae are nonpyrogenic, single use, and sterile.

These Cannulae are intended for use in conjunction with cardiopulmonary bypass surgery up to six hours or less for delivery of cardioplegia solutions directly to the coronary arteries.

The DLP™ Silicone Coronary Artery Ostial Cannulae feature a soft bulb beveled tip with a silicone body. The Cannulae terminate with a locking female luer fitting. The Cannulae are nonpyrogenic, single use, and sterile.

Quantum Perfusion Dual Lumen Cannula is intended for use as a single cannula for both venous drainage and reinfusion of blood via the internal jugular vein during extracorporeal life support procedures for periods of maximum 6 hours.

All medical devices pertaining to Quantum Perfusion Dual Lumen Cannula product family are single use devices intended to be used in medical procedures providing cardiac and/or respiratory support up to 6 hours. Devices are characterized by two coaxial catheters and are designed to be coupled with an extracorporeal circuit for artificial oxygenation of the blood and carbon dioxide removal. Devices exploit a single site insertion which reduces the invasiveness of extracorporeal procedures. It can be inserted via a percutaneous approach through the right internal jugular vein. Blood is drained through the lumen of the outer catheter and returned through the lumen of the inner catheter. Devices feature multiple inflow openings in the outer catheter limiting the circulation of unoxygenated blood. Devices are non-toxic, non-pyrogenic, sterilized by ethylene oxide and packaged in a double pouch. All the devices' surfaces in contact with blood are coated with a phosphorylcholinebased biocompatible material.

Quantum SuperPAC Tubing set is a set of tubing intended for use during cardiopulmonary bypass for a duration up to 6 hours. Quantum SuperPAC Cardioplegia Set is a tubing set used for the infusion of cardioplegia solutions and physiological fluids during cardiac surgery procedures on the heart and great vessels for up to six hours.

Quantum SuperPAC Tubing set devices are designed to connect different devices that are not provided in the Quantum SuperPAC tubing set such as oxygenators, pumps, reservoirs, filters, and other cardiopulmonary bypass components into circuits used in surgical procedures requiring extracorporeal support, for a maximum duration of 6 hours. Quantum SuperPAC Cardioplegia set devices are designed to connect different devices that are not provided in the Quantum SuperPAC tubing set for the infusion of cardioplegia solutions and physiological fluids during cardiac surgery procedures on the heart and great vessels for up to six hours. Quantum SuperPAC devices (all variants) are non-toxic, non-pyrogenic, and sterilized by ethylene oxide. Devices are intended for single use only and are not to be resterilized by the user. All the device surfaces in contact with blood are treated with a phosphorylcholine-based coating. Quantum SuperPAC devices (all variants) are mainly constituted of polyvinyl chloride (PVC) DOP free tubing and additional components composing the set; different variants are available, varying for tubing dimension and set configuration in order to address customer and surgical procedure specifications.