Inspire

The Inspire family

• Has been designed to be fully modular, allowing clinicians an unprecedented choice.
• Features ten integrated oxygenator systems, created by combining three Hard-Shell Venous Reservoirs (HVR) and four oxygenator modules.

To best fit the variety of perfusion practices and adult patient needs, the new family features:

• Full size adult 8 LPM and optimized size adult 6 LPM oxygenator modules, both with and without an integrated arterial filter.
• Single chamber Hard-Shell Venous Reservoirs (HVR) and unique DUAL chamber HVR reservoirs for advanced perfusion practices.

The new Inspire family allows clinicians to safely and comfortably run perfusion while ensuring powerful, consistent performance.

• Its long path oxygenator membrane with remarkably efficient longitudinal flow design allows high gas exchange at all rated flows.
• Its polyurethane heat exchanger is capable of highly efficient heat transfer.

Minimizing hemodilution contributes to decreased blood transfusions and improved clinical outcomes during and after cardiopulmonary bypass (CPB).

• By focusing on a new attribute, the oxygenator system dynamic operating volume (DOV), the Inspire family minimizes the overall impact on hemodilution.
• INSPIRE devices are characterized by the lowest minimum operating level in the reservoir (150 ml), outstanding low venous filter dynamic hold-up volume and low prime oxygenator modules.

Gaseous microemboli are commonly indicated as potential sources of neurological damage after CPB.

• Dedicated design solutions within the Inspire HVR and HVR Dual and the Inspire oxygenator modules ensure effective gaseous microemboli (GME) control.
• Thanks to its dedicated compartment, the integrated arterial filter design offers superior GME handling compared to competitive designs, while ensuring minimized impact on hemodilution.

The Inspire family is flexible and versatile.

• Inspire is the most vertically compact oxygenator system on the market today. It allows optimal handling during the case and minimal storage on the shelf. A single, newly designed bracket fits the entire family for maximum convenience.
• Ergonomics, port orientation, and system priming have been optimized to offer easy set-up and operational flexibility.

The goal of optimized perfusion is to minimize the impact of CPB on patient outcomes by reducing hemodilution and blood contact surface area, minimizing GME and improving biocompatibility, while providing high performance.

• Prior to the introduction of Inspire, small adult devices have been considered the benchmark for optimized perfusion, but were limited in flow to 5 LPM.
• The new Inspire 6 LPM optimized adult oxygenator systems extend the benefits of small adult devices to a wider patient population.

LivaNova products for cardiopulmonary bypass have helped clinicians provide safe and effective perfusion for more than 40 years.

Today, LivaNova has decided to move one step further by offering not only single products but a complete cardiopulmonary bypass system: HeartLink.

Based on our world leading heart lung machine technology, Heartlink is the first perfusion system to provide a unique link between perfusion data, patient parameters and product information to assist with goal-directed perfusion principles. 

Cardiopulmonary bypass generates a large amount of data, which must be considered during the case and recorded as part of the patient record.

Connect can offer an innovative link that assists with managing information from multiple sources.

• By integrating in one electronic database Inspire perfusion circuit information with the perfusion parameters of the S5/C5 Heart Lung machines, and the data of XTRA autotransfusion system and other devices, clinicians can now have improved traceability, accuracy, and automatic case data logging.
• This system will allow clinicians to focus on critical patient care activities rather than manually recording data.

The collected information from Connect can also be displayed in real time to support perfusionists:

• The new GDP Monitor, available only as part of Connect, can assist clinicians in their effort to monitor and continuously improve the quality of perfusion.
• GDP Monitor is the new feature inside Connect that allows the implementation and monitoring of goal-directed perfusion principles in the operating room.
• Quantifying the adequacy of perfusion for each patient may contribute to shorter ICU & hospital stays.

Outstanding feedback from clinicians:

"Overall an easy to set up system, with good heat exchanger performance, very good gas exchange performance. Easy to prime, great visibility of components. Lower prime volume, less hemodilution and potentially less blood product usage. Holder and brackets work very well"

Inspire was extensively evaluated before its commercial launch in a global market assessment study.

• The study evaluated Inspire clinically on over 2000 patients at 80 centers in 24 countries.
• The MAS experience collected input from over 250 clinicians, resulting in a comprehensive database that provides an invaluable source of information for data analysis.

Listening to clinician's feedback is a crucial part of our mission.

Reduction in priming volume, reservoir performance, gas exchange and heat exchange were consistently rated as the most compelling features of the Inspire devices.

Clinicians participating in the MAS were asked to suggest enhancements that would make Inspire even better.

Prior to launch, several of these suggestions were integrated in the final design. 

In the MAS study, a vast majority of clinicians felt Inspire helped them provide additional clinical benefits to their patients.

When compared to currently used oxygenator systems, clinicians highlighted the following benefits that Inspire devices offer:

• Higher hematocrit during CPB
• Reduced priming volume
• Lower blood level in the reservoir

Summary of Safety & Performance Information for INSPIRE

1. INDICATIONS FOR USE / INTENDED PURPOSE
Inspire Oxygenator (Models: Inspire 6, Inspire 7, Inspire 8)
The devices are indicated for adult and small adult patients undergoing surgical procedures requiring cardiopulmonary bypass
The devices are extracorporeal circulation devices used to replace the patient respiratory function during cardiopulmonary bypass procedures. They are used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood, and to cool or warm the blood during cardiopulmonary bypass procedures.
The devices must be to be used up to 6 hours or less

Inspire Oxygenator with integrated arterial filter (Models: Inspire 6F, Inspire 7F, Inspire 8F)
The devices are indicated for adult and small adult patients undergoing surgical procedures requiring cardiopulmonary bypass
The devices are extracorporeal circulation devices used to replace the patient respiratory function during cardiopulmonary bypass procedures. They are used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood, and to cool or warm the blood during cardiopulmonary bypass procedures.
The integrated arterial filter provides filtration against air and solid emboli
The devices must be to be used up to 6 hours or less

Inspire Cardiotomy/venous reservoir (Models HVR, and HVR dual)
The devices are indicated for adult and small adult patients undergoing surgical procedures requiring cardiopulmonary bypass
The devices are extracorporeal circulation devices allowing oxygenators to exploit gas exchange for the replacement of patient respiratory function during cardiopulmonary bypass procedures., providing dynamic patient’s venous blood collection. They also defoam and filter venous blood and suction blood through a filtering system made of antifoam agent and filter screen. Can be used post-operatively for chest drainage.
The devices must be to be used up to 6 hours or less

2. CONTRAINDICATIONS
No contraindications are known if the device is used for the purpose described and in accordance with the stated operating conditions. Do not use the device for any purpose other than indicated.

3. WARNINGS
The device must be used in accordance with the instructions for use provided in the Instructions for Use. . For a complete listing of warnings please refer to the Instructions for Use which accompany each product

4. PRECAUTIONS
Federal law (U.S.A.) restricts this device to sale by or on the order of a physician. For a complete listing of precautions/cautions please refer to the Instructions for Use which accompany each product

5. ADVERSE EVENTS
The following table summarizes harms potentially arising during the use of the medical device, including those related to the intrinsic risks of extracorporeal circulation:. Systemic Inflammatory Response Syndrome (SIRS), Hypoperfusion / Hypoxia, Embolism / Hypovolemia / Sepsis / Infection / Fever / Shock/ Allergic reactions / Cyto-toxic reactions / Genetic mutation / Cancer / Haemolysis / Organ damage / Acid base imbalance (only for oxygenator) / Cross contamination / User contamination / Environment contamination / Thrombosis / Impaired hemostasis / Blood activation / Bleeding / User skin tears and Pneumothorax (only for cardiotomy/venous reservoir)

6. PERFORMANCE INFORMATION
The devices are designed to come into contact with patient blood and are single use, non-toxic, non-pyrogenic, supplied sterile in individual packaging. Sterilised by ethylene oxide. The level of ethylene oxide residuals in the device is within the limits established by national regulations in the country of use.

The device are coated with Phisio (PC phosphorylcholine) coating. Devices coated with Phisio are used when a coated blood path is desired

The devices should be used by qualified and skilled personnel, able to follow the indications and instructions for use contained in the information provided by the manufacturer. Please contact us through our website to receive instructions for use containing full prescribing information including indications, contraindications, warnings, precautions and adverse events.

The information contained in this summary represents partial excerpts taken from the product labeling. The information is not intended to serve as a substitute for a complete and through understanding of the device nor does this information represent full disclosure of all pertinent information concerning the use of this product.

Manufactured by:
Sorin Group Italia Srl
A wholly-owned subsidiary of LivaNova PLC
Via Statale 12 Nord, 86
41037 Mirandola (MO) Italy
Теl: +39 0535 29811 - Fax: +39 0535 25229
info.cardiacsurgery@livanova.com