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The Protek Solo 24 Fr Venous Cannula is intended to cannulate vessels or organs and/or connect with accessory extracorporeal circulatory support equipment. The introducer is intended to facilitate proper insertion and placement of the cannula within the vessel for extracorporeal circulatory support. These devices are to be used by a trained physician only.

The Protek Solo 24 Fr Venous Cannula Set consists of two components: a 24 Fr single lumen cannula and a 21 Fr. Introducer. The Introducer is designed to accept a standard 0.038 inch guidewire. The Protek Solo 24 Fr Venous Cannula Set is intended as a single patient, single use, sterile device. A. 24 Fr Venous Cannula The 24 Fr Venous Cannula (Figure 1) consists of a single lumen made of polyurethane with a wire-reinforced cannula body. The cannula has an insertable length of 60 cm. The distal section (insertable length) is 24 Fr with sixteen side holes spanning the distal 6.6" (16.8 cm) of the cannula. The proximal section of the cannula is clear and not wire-reinforced to allow visualization of blood and to enable clamping to prevent blood flow during set-up and removal. A non-vented barbed connector is affixed to the proximal end of the cannula and allows for connection of standard 3/8" blood circuit tubing. The cannula has printed insertion depth markings every 10 centimeters from 10 to 40 cm followed by every 2 centimeters for the rest of the insertable length measured from the distal end. The cannula also has a suture wing that can be used for securing the cannula in place to the patient. B. Introducer The 21 Fr introducer (Figure 2) consists of a PVC tube with a PVC hub. The introducer fits inside the inner lumen of the cannula during insertion of the cannula/introducer assembly. The introducer (Figure 2) is used to advance the cannula over a guidewire and facilitate cannula placement within the target vessel. The introducer has a hub at its proximal end to manage introducer insertion and removal from the cannula. The hemostasis cap minimizes blood loss when the cannula/introducer assembly is inserted into the target vessel. The introducer body is constructed from radiopaque PVC material for visualization under fluoroscopy.

The PROTEK Duo 31 Fr. Veno-Venous Cannula Set is intended for use as a single cannula for both venous drainage and reinfusion of blood via an internal jugular vein during extracorporeal life support procedures.

The PROTEK Duo 31 Fr. Veno-Venous Cannula Set consists of two components: a 31 Fr. Dual lumen Veno-Venous Cannula and a 15.5 Fr. Introducer. The Introducer is designed to accept a standard 0.038 inch guidewire. The PROTEK Duo 31 Fr. Veno-Venous Cannula Set is intended as a single patient, single use, sterile device. The PROTEK Duo 31 Fr. Veno-Venous Cannula (Figure 1) consists of two distinct lumens with a wire-reinforced cannula body. The inner lumen is located entirely within the outer lumen forming two concentric channels. The distal section (inner lumen/cannula) of the cannula body has six side holes near the distal tip opening. The proximal sections of each lumen are clear and not wire-reinforced to allow visualization of blood and to enable clamping to prevent blood flow during setup and removal of the cannula from the extracorporeal circulatory support equipment (see Figure 1). A non-vented barbed connector is affixed to both proximal ends (inner/distal and outer/proximal lumens) of the cannula and allow for connection of standard 3/8 inch blood circuit tubing for subsequent connection to extracorporeal circulatory support equipment. The introducer (Figure 2) consists of a tube with a luer hub. The introducer fits inside the inner lumen of the cannula during insertion of the cannula/introducer assembly. The introducer is used to advance the cannula over a guidewire and facilitate cannula placement within the target vessel. The introducer has a luer hub at its proximal end to manage introducer insertion and removal from the cannula. The luer hub can also enable contrast injection, if necessary, to facilitate placement and final positioning of the cannula within the target vessel. The hemostasis cap minimizes blood loss when the cannula/introducer assembly is inserted into the target vessel. The introducer body is constructed from radiopaque material for visualization under fluoroscopy.

The TandemLung Oxygenator (TLO) is intended to be used for adult patients for extracorporeal circulation during cardiopulmonary bypass in the field of open-heart surgery. Within the indicated flow rates, blood is oxygenated and carbon dioxide is removed. The utilization period of this device is restricted to six hours.

The TandemLung Oxygenator TLO consists of an injection molded exterior shell containing a bundle of Polymethylpentene (PMP) hollow fiber membranes in which blood is oxygenated and decarbonated. Sweep gas, primarily oxygen, is supplied to interior lumens of the fibers and diffuses from the fiber wall to the blood plasma via simple diffusion. Similarly, carbon dioxide diffuses from the blood into the inner lumen of the fibers and is exhausted. Arterialized blood exits out of the blood outlet port and is delivered to the patient. A two part polyurethane "potting" compound is used to both mechanically fix the end of the hollow fiber membranes in place and to create a barrier between the blood and gas pathways within the TLO. Use of the TLO requires use of a pump and cannula(s), as well as tubing and connectors/fittings.

The TandemHeart Venous Cannula Set is intended to cannulate vessels, perfuse vessels or organs and/or connect with accessory extracorporeal circulatory support equipment. The cannula obturator and dilator are intended to facilitate proper insertion and placement of the cannula within the vessel for extracorporeal circulatory support.

The TandemHeart Venous Cannula Set consists of three components, as shown in Figure 1: a 21 Fr. Venous Cannula. 14 Fr. Obturator, and an optional 14/21 Fr. Two-stage Dilator, that accepts a 0.035 in. guidewire. The device is intended to cannulate vessels or organs, and/or connect with accessory extracorporeal circulatory support equipment. The product is intended to be single patient, single use, sterile device. The cannulae are available in two configurations: 1. 21 Fr. x 62 cm. with options for tip curvature of 0° and 50° 2. 21 Fr. x 72 cm. with tip curvature of 50°. The cannula has multiple side holes in addition to the tip opening for unimpeded flow of blood at the distal end and a barbed fitting at the proximal end to enable the connection of 3/8" tubing. Radiopaque markers are embedded at the distal tip of the cannula, and the cannula body is wirereinforced for visualization under fluoroscopy. Insertion depth markings are incorporated in the cannula body from 10 to 62 or 72 cm, depending on the length option, measured from the distal tip. The cannula includes a suture wing to provide a means for securing the cannula to the patient. Printing on the proximal region of the cannula indicates the area where a clamp should be applied if needed during the set-up or the removal process. The 14 Fr. Obturator is provided to facilitate placement of the venous cannula, within the target vessel, and is designed with a tapered distal tip. The Obturator proximal end contains a luer hub to aid in the removal of the obturator. The Obturator body is constructed of a radiopaque material for visualization under fluoroscopy: The Obturator includes a hemostasis cap that provides the interface between the cannula proximal connector and obturator body. The hemostasis cap aids in minimizing blood loss during the insertion of the cannula/obturator assembly into the target vessel. The 14/21 Fr. Dilator is provided to aid introduction of the obturator/cannula assembly at the insertion site.

The TandemHeart Transseptal Cannula Set-EF 72 is intended for transseptal catheterization of the left atrium via the femoral vein for the purpose of providing a means for temporary (six hours or less) left ventricular bypass when connected to the TandemHeart extracorporeal blood pump which returns blood to the patient via the femoral artery or other appropriate site.

The TandemHeart Transseptal Cannula Set-EF 72 consists of three main components, a 21 Fr Transseptal Cannula, a 14 Fr Obturator, and a 14/21 Fr Two-stage Dilator which are intended for the drainage of the left atrium during left ventricular bypass.

The TandemHeart Escort Controller is intended to be used with the TandemHeart PTVA System. The TandemHeart PTVA System consists of the TandemHeart PTVA Blood Pump, a single use, disposable device; The TandemHeart Escort (T.H.E.) Controller, a reusable control system for the TandemHeart PTVA Blood Pump; and disposable accessory items used in conjunction with the TandemHeart PTVA System. In the U.S., the TandemHeart PTVA System is intended for extracorporeal circulatory support using an extracorporeal bypass circuit. Intended duration of use is for periods appropriate to cardiopulmonary bypass, up to six hours. It is also intended to be used as an extracorporeal circulatory support system (for periods up to six hours) for procedures not requiring complete cardiopulmonary bypass (e.g., valvuloplasty, mitral valve reoperation, surgery of the vena cava and/or aorta, liver transplant, etc.)

The TandemHeart Escort (T.H.E) Controller is a microprocessor-based pump motor drive and infusion system. It is designed to operate on AC current (110/240 VAC, 50/60 Hz) or on internal, rechargeable batteries for intra-hospital transport. The T.H.E Controller generates the signals required to power the drive motor of the TandemHeart Blood Pump, which turns the impeller to propel blood through the Pump. The system works independently of the heart. The Controller also serves to deliver the infusate into the TandemHeart Blood Pump and to provide information regarding system performance including measured flow. It is portable and designed to be pole mounted, hung from a horizontal bed rail, or placed on a table top. It is simple to use, with an integral backup motor control circuit, and backup batteries for redundant operation.

The TandemHeart Transseptal Cannula Set - EF is intended for transseptal catheterization of the left atrium via the femoral vein for the purpose of providing a means for temporary (six hours or less) left ventricular bypass when connected to the TandemHeart extracorporeal blood pump which returns blood to the patient via the femoral artery or other appropriate site.

The TandemHeart Transseptal Cannula Set-EF consists of three components, as shown in Figure 1: (1) 21 Fr Transseptal Cannula, (2) 14 Fr Obturator, and (3) 14/21 Fr Two-stage Dilator. The Obturator and Dilator are designed to accept a standard 0.035 in. guidewire. The 21 Fr Transseptal Cannula allows for drainage of the left atrium during left ventricular bypass. It has 14 side holes in addition to the tip opening for unimpeded inflow of blood at the distal end, a barbed fitting at the proximal end, and insertion depth markings from 40 to 62 cm measured from the distal end. The Cannula also includes a Suture Wing to provide a means for securing the Cannula to the patient. The 21 Fr body of the Cannula includes a wire-reinforced area for clear visualization under fluoroscopy and for resistance to kinking. The wire-reinforcing also permits a thin-walled construction. This feature allows for a larger inside diameter (lumen) while maintaining the predicate CAI cannula's outside diameter. Consequently, greater flow can be achieved with the same pressure drop across the cannula versus the predicate CAI cannula. Printing on a region of the cannula which is not wire-reinforced indicates the area where a clamp should be applied as needed during the set-up or removal process. The distal end of the Cannula is curved for natural anatomical placement from the inferior vena cava into the left atrium. The printing on the cannula is oriented to show the clinician that the distal tip curves to the right when the printing is on the top of the cannula body. The 14 Fr Obturator is used to advance the Cannula over a guidewire to the right atrium from the inguinal area and then across the atrial septum into the left atrium. It contains a Luer hub and flush side holes at both the distal and proximal ends to facilitate de-airing and to allow for use of contrast material to confirm final positioning of the Cannula. An hemostasis cap prevents excessive blood loss when the Cannula/Obturator assembly is inserted into the femoral vein. The Obturator body is fabricated of radionaly is fa for easy visualization under fluoroscopy. The 14/21 Fr. Dilator is provided for pre-dilation of the fossa ovalis once left atrial access is achieved via standard transseptal technique and a guidewire has been placed into the left atrium. The stepped design of the distal tip of the Dilator provides tactile feedbak to the clinician as the dilation is achieved. The Dilator is fabricated of radiopaque material for easy visualization under fluoroscopy.

The CardiacAssist Transseptal Cannula Set is intended for transseptal catheterization of the left atrium via the femoral vein for the purpose of providing a means for temporary (six hours or less) left ventricular bypass when connected to a suitable extracorporeal blood pump unit which returns blood to the patient via the femoral artery or other appropriate site.

The Transseptal Cannula Set consists of three components: (1) 21 Fr. Transseptal Cannula, (2) 13 Fr. Obturator, and (3) 14/21 Fr. Two-stage Dilator, that accept a 0.035 in. guidewire. The 21 Fr. Transseptal Cannula (Figure 1) allows for drainage of the left atrium during ventricular bypass. It has 14 side holes in addition to the tip opening for inflow at the distal end, a barbed fitting at the proximal end, and insertion depth markings from 40 to 62 cm measured from the distal end. The Transseptal Cannula also includes a Suture Wing and 2 Suture Rings to provide a means for securing it to the patient. The 13 Fr. Obturator (Figure 2) is used to advance the Cannula to the right atrium from the inguinal area and then across the atrial septum into the left atrium. It contains a luer hub and aspiration side holes at both the distal and proximal ends to facilitate de-airing and to allow for use of contrast material to facilitate final positioning of the Cannula. It also contains a radiopaque marker band proximal to the Cannula drainage holes when the Obturator is inserted in the Cannula. The 14/21 Fr. Dilator (Figure 3) is provided for pre-dilation of the fossa ovalis once left atrial access is achieved via standard transseptal technique.

The AB-180 XC Blood Pump is a single use, disposable centrifugal blood pump designed to circulate blood through an extracorporeal circuit. The AB-180 XC Blood Pump is intended for extracorporeal circulatory support using an extracorporeal bypass circuit. Intended duration of use is for periods appropriate to cardiopulmonary bypass, up to six hours. It is also intended to be used as an extracorporeal circulatory support system (for periods up to six hours) for procedures not requiring complete cardiopulmonary bypass (e.g. valvuloplasty, mitral valve reoperation, surgery of the vena cava and/or aorta, liver transplant, etc.)

The AB-180 XC Blood Pump provides extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusate system. The Pump is electrically driven and can only be used with the AB-180 XD Blood Pump Controller. The AB-180 XD Blood Pump Controller provides pump monitoring, manual pump speed variability and a constant flow of infusate to the Pump. The AB-180 XC Blood Pump consists of an upper and lower housing. The upper housing encloses the blood contact area of the Pump and holds the impeller, which propels the blood through the Pump. This chamber has a low priming volume. Two tubes connect to this chamber allowing easy connection to extracorporeal circulatory support circuits. The lower housing contains the main rotating component (the rotor) and has an inlet port for the infusion fluid. This infusate acts as a fluid bearing and a local anticoagulation delivery system.