Essenz Patient Stories

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Matilde and her family's story

Matilde underwent life-saving surgery at just 15 months of age. Thanks to the expertise of her medical team, her life was forever changed.

This case was one of the first of its kind using the Essenz Perfusion System to support the patient during an open heart procedure. But it is not just a story about innovation; it is a testament to courage, resilience, and the power of collaboration. In this video, Matilde’s parents tell us about their story and that of the people who worked together to help their daughter.

Matilde's story — the clinical view

Key members of San Donato Hospital's OR team remember Matilde's case and her journey to health.

Dr. Varrica, Cardiac Surgeon, and Dr. Cotza, Chief Perfusionist, were instrumental in helping Matilde as she prepared and underwent open-heart surgery. They remind us of the importance of being connected to patients and their families throughout these critical medical journeys.

Safety Information

Summary of Safety & Performance Information for Essenz™ Perfusion System

Heart-Lung Machine with Integrated Essenz In-Line Blood Monitor (ILBM)

The Essenz Heart-Lung Machine is intended to perform, control, monitor and support extracorporeal blood circulation replacing the mechanical pumping function of the heart, monitoring and regulating physiologic parameters during procedures requiring extracorporeal circulation.

Essenz Patient Monitor
The Essenz Patient Monitor software is a modularly structured software program package that is exclusively used with LivaNova heart-lung machines. The system allows detailed recording of perfusion data during cardiopulmonary bypass procedures as well as the processing and evaluation of this data. The data may be recorded automatically or entered manually. The LivaNova Perfusion System Monitor is a panel PC intended to be exclusively used with LivaNova heart lung machines as a base and user interface for the Essenz Patient Monitor software.

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

WARNINGS: The devices must be used in accordance with the instructions for use provided. For a complete listing of warnings please refer to the Instructions for Use. Medical intervention and therapeutic procedure must not be based solely on the Essenz Patient Monitor perfusion records (reports).

PRECAUTIONS: Federal law (U.S.A.) restricts these devices to sale by or on the order of a physician. For a complete listing of precautions/cautions please refer to the Instructions for Use. 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.

Essenz In-Line Blood Monitor and B-Capta Blood Gas Monitor are clinically equivalent in terms of safety and performance as they have the same technology and intended use. Not approved in all geographies, consult your labeling. Please visit the LivaNova website to receive instructions for use containing full prescribing information including indications, contraindications, warnings, precautions and adverse events.

Legal Manufacturer:
LivaNova Deutschland
Lindberghstrasse 25
D-80939
Munich,
Germany

Sorin Group Italia S.r.l.
Via Statale 12 Nord, 86
41037 Mirandola (MO) ITALY

Perfusion Patient Stories