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TandemLife is now a part of LivaNova, Learn More Here.

COVID-19 UPDATES:The U.S. Food and Drug Administration (FDA) issued guidance on April 6, 2020 to temporarily expand the availability of devices used in extracorporeal membrane oxygenation (ECMO) therapy to address the novel coronavirus (COVID-19) public health emergency. As a result of the guidance, cardiopulmonary devices, including select devices from TandemLife | LivaNova, are now temporarily indicated for ECMO therapy greater than 6 hours. To read the full announcement, click here.

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TandemLung Kit logo

Reinvented Respiratory Support.

Accelerate beyond the tools of the past; upgrade your patients to TandemLung and deliver advanced respiratory care for the 21st century.
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TandemLung RA-PA Configuration with ProtekDuo

In the event of respiratory arrest, temporary support is critical in enabling physicians to assess patients’ conditions to determine the root cause and a longer-term treatment strategy.  Historically initiating emergent respiratory rescue has been difficult due to the complexity of the devices.

The TandemLung kit is designed to address two major roadblocks that have prevented emergent veno-venous cardiopulmonary bypass from becoming a new standard of care; the difficulty of initiating support, and the level of complexity of devices and patient management.

The TandemLung kit offers the ProtekDuo co-axial dual lumen cannula indicated for venous drainage and infusion as well as a quick prime membrane oxygenator & blood pump indicated for up to 6 hours of use.  TandemLung provides a “time to decide” strategy with short term support during the acute event.

The TandemLung kit components are indicated for temporary cardiopulmonary bypass up to 6 hours.

Features

  • Right internal jugular vein insertion
  • Stable, RA-PA configuration to reduce recirculation
  • Pre-connected pump and oxygenator for quick priming
  • Shortest total circuit length on the market
  • Circuit organization with the VoyagerVest

TandemLung IVC-RA Configuration with ProtekDuo RD

Shorter. Faster. Simpler. The TandemLung RD is more than a cannula, it is an all-in-one ECLS solution designed for rapid respiratory support in minutes.

In emergent respiratory support, seconds count. The platform offers the versatility to move from the TandemLung RD in an emergent situation to a higher-level of support once stabilized.

The kit features a pre-assembled pump and oxygenator housed in a sterile priming basin along with the ProtekDuo RD cannula.

The single-use dual lumen cannula is wire reinforced to offer both venous drainage and reinfusion of the blood via the Right internal jugular vein. The unique cannula design features a 360 degree drainage return and distribution ports for focused support.

The TandemLung RD kit components are indicated for temporary cardiopulmonary bypass up to 6 hours.

Features

  • Right internal jugular vein insertion
  • Stable, RA-PA configuration to reduce recirculation
  • Pre-connected pump and oxygenator for quick priming
  • Shortest total circuit length on the market
  • Circuit organization with the VoyagerVest

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Included Products

LifSPARC Pump

LifSPARC Pump

Experience bypass in the palm of your hand. The TandemHeart Pump can be used in the Cardiac Catherization Lab or the Operating Room in a vast variety of configurations

TandemLung Oxygenator

TandemLung Oxygenator

Think outside of the box. The TandemLung’s sleek design features patented radial flow technology lowering flow resistance, enabling the pump to move blood more efficiently.

ProtekDuo or ProtekDuo RD Cannula

ProtekDuo or ProtekDuo RD Cannula

The cannulae with all of the right moves. The ProtekDuo and ProtekDuo RD cannulae were designed to be implemented in multiple configurations. The patented omni-directional inflow/outflow port is designed to mitigate recirculation and provide 360-degree flow.

Priming Tray

Priming Tray

The priming tray was designed to provide customers with a quick and repeatable priming process that can be implemented virtually anywhere and anytime TandemLife or TandemLung support is needed.

Voyager Vest

TandemLife has created the world’s first and only wearable ECLS platform, helping to secure and organize the circuit for ease in patient management

  • Secure the circuit with three simple components: vest, holster and halo
  • Biocompatible vest placed over the shoulders maintains access to the chest
  • Custom-designed holster secures the on-patient TandemHeart® or LifeSPARC® pump, the TandemLung® oxygenator, and all 3/8” tubing
  • Detachable halo secures all 3/8” tubing without restricting head movement
  • Convenient tubing clips take away the tangle of tubing whether the patient is sitting, standing, or lying in bed

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.