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.”
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
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].
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”.
Safe harbor statement
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. These statements can be identified by the use of forward-looking terminology, including "may," "believe," "will," "expect," "anticipate," "estimate," "plan," "intend," "forecast," or other similar words. Statements contained in this press release are based on information presently available to LivaNova and assumptions that the parties believe to be reasonable. LivaNova is not assuming any duty to update this information if those facts change or if the assumptions are no longer believed to be reasonable. Investors are cautioned that all such statements involve risks and uncertainties, 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 in which the company operates; the ability to hire and retain key personnel; the ability to attract new customers and retain existing customers in the manner anticipated; reliance on and integration of information technology systems; changes in legislation or governmental regulations affecting the company; international, national or local economic, social or political conditions that could adversely affect the 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 annual reports, registration documents and other documents filed from time to time with CONSOB by Sorin. LivaNova does not give any assurance (1) that LivaNova will achieve its expectations, or (2) concerning any result or the timing thereof, in each case, with respect to any regulatory action, administrative proceedings, government investigations, litigation, warning letters, consent decree, cost reductions, business strategies, earnings or revenue trends or future financial results.
For more information, please visit www.livanova.com
Chief Financial Officer
Investor Relations and Media:
Greg Browne, Phone: +1 (281) 228-7262
Fax: +1 (281) 218-9332
Senior Vice President, Finance
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