LifeSPARC: In the U.S., the LifeSPARC system is intended to pump blood through an extracorporeal circuit for periods lasting less than six hours for the purpose of providing either: (i) full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or (ii) temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.
Contraindications for Use: The LifeSPARC System should not be used with extracorporeal circuits that create a pressure differential greater than 600 mmHg between the inflow and the outflow of the Pump. Because of the non- occlusive nature of the LifeSPARC Blood Pump, the Pump should not be used for cardiotomy suction.
TandemHeart Controller: The TandemHeart Escort Controller is intended to be used with the TandemHeart System. The TandemHeart System consists of the TandemHeart Blood Pump, a single use, disposable device; the TandemHeart Escort (T.H.E.) Controller, a reusable control system for the TandemHeart Blood Pump; and disposable accessory items used in conjunction with the TandemHeart System.
TandemHeart Pump: The TandemHeart pump is intended to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either: (i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or (ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.
TandemLung Oxygenator: The TandemLung Oxygenator is intended for use in an extracorporeal circuit requiring cardiopulmonary bypass for application duration limited to six hours. Within the specified flow rate range, the device oxygenates the blood and removes carbon dioxide from the blood. Responsibility for clinical application of the oxygenator rests solely with the attending physician.
Contraindications for Use: No contraindications are known provided the device is used within the Indications for Use and in accordance with the stated operating conditions.
ProtekSolo 62 and 72 cm Transseptal Cannulae: The 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.
Contraindications for Use: The Transseptal Cannula Set should not be used when any anatomical, medical, or physiological impairment may contraindicate the use of a femoral access procedure or transseptal access to the left atrium.
ProtekSolo Venous Cannula: The Venous Cannula and Obturator is intended to cannulate vessels, perfuse vessels or organs and/or connect with accessory extracorporeal circulatory support equipment. The cannula obturator 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.
Contraindications for Use: Alone, the cannula and introducer are not medical treatment devices. There are no known contraindications for the use of the cannula, other than those generally contraindicated for cardiopulmonary bypass. The introducer is only to be used with the appropriately sized Venous Cannula. These devices are not intended for use except as indicated above.
ProtekSolo 15 and 17 Fr Arterial Cannulae: The Femoral Arterial Cannula and Introducer are intended to cannulate vessels, perfuse vessels or organs, and/or connect with accessory extracorporeal circulatory support equipment for a duration of six hours or less. The cannula introducer is intended to facilitate proper insertion and placement of the cannula within the vessel for extracorporeal support. These devices are to be used by a trained physician only.
Contraindications for Use: Alone, the cannula and introducer are not medical treatment devices. There are no known contraindications for the use of the cannula, other than those generally contraindicated for cardiopulmonary bypass. The cannula introducer is only to be used with the appropriately sized TandemHeart Cannula. These devices are not intended for use, except as indicated above.
ProtekDuo 29 and 31 Fr and ProtekDuo RD 31 Fr Veno-Venous Cannulae: The ProtekDuo 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.
Contraindications for Use: Alone, the cannula and introducer are not medical treatment devices. There are no known contraindications for the use of the cannula, other than those generally contraindicated for cardiopulmonary bypass. The cannula Introducer is only to be used with the appropriately sized ProtekDuo Veno-Venous Cannula. These devices are not intended for use except as indicated above.
VoyagerVest: The Voyager Vest is intended to provide secure attachment of Extracorporeal Life Support (ECLS) components (pump, oxygenator, and tubing) to the patient during cardiopulmonary bypass.
Contraindications for Use: The VoyagerVest kit is only intended for use with compatible products manufactured and tested by CardiacAssist, Inc. The VoyagerVest kit should not be used on patients with a known allergy to neoprene.
