Xtra™ Autotransfusion System

1. Overdevest et al. "Clinical evaluation of the Sorin Xtra® autotransfusion system." Perfusion 2012, 27(4) 278–283

2. Bauman et al. (2015) "Evaluation of the minimum volume of salvaged blood required for the successful use of two different autotransfusion device" Pediatric Anesthesia 25 (2015) 258–264

3. Kilic et al. "Blood transfusions in cardiac surgery: indications, risks, and conservation strategies." Ann Thorac Surg. 2014 Feb;97(2):726-34.

4. Kozek-Langenecker et al. “Management of severe perioperative bleeding: Guidelines from the European Society of Anaesthesiology." Eur J Anaesthesiol 2017; 34:332–395

5. Meybohm et al. "Washed cell salvage in surgical patients. A review and meta-analysis of prospective randomized trials under PRISMA." Medicine (Baltimore). 2016 Aug;95(31):e4490

6. Roberts et al. "The global need and availability of blood products: a modelling study." Lancet Haematol. 2019 Dec;6(12):e606-e615.

7. Vonk et al. "Intraoperative cell salvage is associated with reduced postoperative blood loss and transfusionrequirements in cardiac surgery: a cohort study." Transfusion. 2013 Nov;53(11):2782-9.

8. Côté et al. "Efficacy of intraoperative cell salvage in decreasing perioperative blood transfusion rates in first-time cardiac surgery patients: a retrospective study." Can J Surg. 2016 Sep;59(5):330-6.

9. Robich et al. "Trends in blood utilization in United States cardiac surgical patients." Transfusion. 2015 Apr;55(4):805-14.

10. Geissler et al. "Utilisation of blood components in cardiac surgery: a single-centre retrospectiveanalysis with regard to diagnosis-related procedures." Transfus Med Hemother . 2015 Mar;42(2):75-82.

11. Ad et al. "Effect of patient age on blood product transfusion after cardiac surgery." The Journal of Thoracic and Cardiovascular Surgery, 19 Mar 2015, 150(1):209-214

12. Carling et al."Transfusions and blood loss in total hip and knee arthroplasty: a prospective observational study." J Orthop Surg Res. 2015 Mar 28;10:48.

13. Carless et al. "Cell salvage for minimising perioperative allogeneic blood transfusion." Cochrane Database Syst Rev. 2010 Mar 17;(3):CD001888. doi: 10.1002/14651858.CD001888.pub3. Review. Update in Cochrane Database Syst Rev. 2010;(4):CD001888.

14. Shenolikar A, et al. "Cell salvage auto transfusion in total knee replacement surgery." Transfus Med. 1997;7:277–80.

1. INDICATIONS FOR USE / INTENDED PURPOSE

EU/International: XTRA is indicated for use for intraoperative recovery of blood, washing of blood collected in the postoperative period and preoperative sequestration (with indirect patient connection). The XVAC is indicated for use for intraoperative and postoperative recovery of blood for autotransfusion procedures. Intraoperative blood salvage is widely employed in surgical procedures where blood loss occurs during the course of the operation, whereas postoperative blood salvage is used in surgical procedures where bleeding may occur during the postoperative course. Typical clinical applications of autotransfusion include the following surgical specialties: Cardiovascular, Orthopedics, Thoracic, Transplant Surgery, Emergency (Trauma), Neurosurgery, Obstetrics and Gynecology, and Urology.

US: The XTRA Autotransfusion System is indicated for intraoperative and postoperative recovery of blood, washing of the processed blood and preoperative sequestration (with indirect patient connection). Typical clinical applications of autotransfusion include the following surgical specialties: Cardiovascular, Orthopedics, Thoracic, Transplant Surgery, Emergency (Trauma), Neurosurgery, Obstetrics and Gynecology, and Urology. The XVAC is indicated for use only with the XTRA, an autologous blood recovery system indicated for intra-and post-operative autotransfusion, as well as for pre-operative sequestration.

2. CONTRAINDICATIONS

There are no known contraindications for the XTRA. However, the use of blood processed by this device may be contraindicated under some circumstances. The responsibility for the use of the device in all cases belongs solely to the physician in charge.

3. WARNINGS

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

4. PRECAUTIONS

The XTRA must be used only with XTRA disposables. 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.

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 (www.sorinmanuals.com) 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. Not approved in all geographies. Consult your labeling.

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

Distributed in the USA by:
LivaNova USA
14401 W 65th Way
Arvada, CO 80004