Study Shows Sorin XTRA(TM) Autotransfusion System Achieves High Fat Removal Rate

LivaNova PLC (NASDAQ:LIVN)(LSE:LIVN) today announced the publication of study results showing that the new “Pfat” software protocol developed for the XTRA autotransfusion system effectively eliminates lipid particles.

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The importance of autotransfusion in optimal patient blood management, during surgical procedures, has been widely documented.¹ In addition to the inflammatory risks associated with homologous blood transfusion, neuropsychological disorders and brain injury are among other potentially serious complications for patients undergoing cardiac surgery and other surgical applications, with lipid embolism being a significant contributor.^2,3,4

In addition to reducing inflammatory risks by collecting, processing and re-infusing the patient's own blood shed perioperatively, Livanova’s Sorin XTRA autotransfusion system now features the new “Pfat” protocol, designed to remove fat particles from intraoperative and postoperative shed blood.

In the study titled “Fat removal during cell salvage: an optimized program for a discontinuous autotransfusion device” published on Transfusion, Seyfried et al. reported that the XTRA system incorporating the new “Pfat” protocol averaged fat removal rates higher than 99 percent using a 225 ml bowl on 10% and 25% inlet haematocrit.⁵

“With such an effective fat removal capacity, the new Pfat protocol is equivalent in performance to continuous autotransfusion systems such as Fresenius CATS,” said study co-author Prof. Ernil Hansen, Dr.med. Dr.rer.nat., Universitätsklinikum Regensburg, Regensburg, Germany.

In addition to XTRA’s fat removal capability, the study results confirmed that the “Pfat” protocol maintains high values for red blood cell recovery rate and supernatant elimination rate. Study researchers also found that the high fat removal rate experienced with Pfat is independent of bowl size or blood haematocrit and therefore applies to different clinical situations, including pediatric, cardiac and orthopaedic surgery.¹

“XTRA was designed to meet the most demanding blood management program requirements, ensuring patient safety and improving outcomes,” said Michel Darnaud, President, Cardiac Surgery B.U., LivaNova PLC. “This original research validates the innovative design and methodology used in the development of our autotransfusion system, and demonstrates that current clinical challenges in effective blood management can be confidently met using our advanced technology and new software protocols.”

References

1. *Shander, Aryeh, Hofmann Axel Et al. The true cost of red blood cell transfusions in surgical patients. 2008: Presented at the 50th Annual American Society of Hematology Meeting, The Moscone Center Poster Board III-127).
2. Dabrowski W, Rzecki Z, Pilat J, Czajkowski M. Brain damage in cardiac surgery patients. Curr Opin Pharmacol. 2012 Apr;12(2):189-94.
3. Piuzzi NS, Zanotti G, Comba FM, Buttaro MA, Piccaluga F. Paradoxical cerebral fat embolism in revision hip surgery. Case Rep Orthop. 2014; 2014:140757.
4. Cox G, Tzioupis C, Calori GM, Green J, Seligson D, Giannoudis PV. Cerebral fat emboli: a trigger of post-operative delirium. Injury. 2011 Sep;42 Suppl 4:S6-S10.
5. Seyfried TF, Gruber M, Breu A, Aumeier C, Zech N, Hansen E. Fat removal during cell salvage: an optimized program for a discontinuous autotransfusion device. Transfusion. 2015 Aug 30. doi: 10.1111/trf.13286. [Epub ahead of print].

About LivaNova
LivaNova PLC, headquartered in London, UK, is a global medical technology company formed by the merger of Sorin S.p.A, a leader in the treatment of cardiovascular diseases, and Cyberonics Inc., a medical device company with core expertise in neuromodulation. LivaNova transforms medical innovation into meaningful solutions for the benefit of patients, healthcare professionals, and healthcare systems. The company employs approximately 4,500 employees worldwide. With a presence in more than 100 countries, LivaNova operates as three business units: Cardiac Rhythm Management, Cardiac Surgery, and Neuromodulation, with operating headquarters in Clamart (France), Mirandola (Italy) and Houston (U.S.A.), respectively.

LivaNova is listed on NASDAQ and listed on the Official List of the UK’s Financial Conduct Authority and traded on London Stock Exchange (LSE) under the ticker symbol “LIVN”.

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Contact information

LivaNova PLC
Investor Relations:
Vivid Sehgal
Chief Financial Officer
e-mail: investor.relations@livanova.com
or
Investor Relations and Media:
Greg Browne, Phone: +1 (281) 228-7262
Fax: +1 (281) 218-9332
Senior Vice President, Finance
e-mail: corporate.communications@livanova.com