LONDON--(BUSINESS WIRE)--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.
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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including without limitation, statements concerning developing novel
opportunities in heart failure, sleep apnea and percutaneous mitral
valve, creating new innovative solutions that benefit patients,
healthcare professionals, and healthcare systems, and building
significant shareholder value. Important factors that may cause actual
results to differ include, but are not limited to: risks that the new
businesses will not be integrated successfully or that the combined
companies will not realize estimated cost savings, value of certain tax
assets, synergies and growth, or that such benefits may take longer to
realize than expected; the inability of LivaNova to meet expectations
regarding the timing, completion and accounting and tax treatments;
risks relating to unanticipated costs of integration, including
operating costs, customer loss or business disruption being greater than
expected; reductions in customer spending, a slowdown in customer
payments and changes in customer demand for products and services;
unanticipated changes relating to competitive factors in the industries
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company or its customers; conditions in the credit markets; risks to the
industries in which LivaNova operates that are described in the "Risk
Factors" section of the Annual Reports on Form 10-K, Quarterly Reports
on Form 10-Q and other documents filed from time to time with the SEC by
Cyberonics, Inc. and LivaNova and the analogous section in annual
reports and other documents filed from time to time by Sorin S.p.A. with
the Italian financial market regulator (CONSOB); risks associated with
assumptions made in connection with critical accounting estimates and
legal proceedings; LivaNova’s' international operations, which are
subject to the risks of currency fluctuations and foreign exchange
controls; and the potential of international unrest, economic downturn
or effects of currencies, tax assessments, tax adjustments, anticipated
tax rates, raw material costs or availability, benefit or retirement
plan costs, or other regulatory compliance costs. The foregoing list of
factors is not exhaustive. You should carefully consider the foregoing
factors and the other risks and uncertainties that affect the parties'
businesses, including those described in Cyberonics' Annual Report on
Form 10-K, as amended from time to time, Quarterly Reports on Form 10-Q,
Current Reports on Form 8-K and other documents filed from time to time
with the SEC by Cyberonics and LivaNova and those described in Sorin's
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(1) that LivaNova will achieve its expectations, or (2) concerning any
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For more information, please visit www.livanova.com