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1 MAR, 2012 - Terumo BCT Submits 510(k) for Mononuclear Cell (MNC) Collection on the Spectra Optia® Apheresis System
2/29/2012

When cleared, MNC on the next-generation platform will offer streamlined operations 

 

LAKEWOOD, Colo.—March 1, 2012—Terumo BCT announced today that it has submitted a 510(k) for the MNC protocol on the Spectra Optia system to the U.S. Food and Drug Administration (FDA). When cleared, therapeutic apheresis operators will gain the benefit of a streamlined procedure on the next-generation therapeutic apheresis platform, as well as simplified user operations, allowing them to spend more time with patients.

 

The submission to the FDA included a clinical analysis on the data results of two U.S. clinical studies.  

 

U.S. Clinical Trials – Patient Study

  • A four-center, single-arm study evaluated the Spectra Optia system for MNC collection in 26 multiple myeloma patients
  • Compared MNC collections using the Spectra Optia system to the historical effectiveness of cells collected using the COBE® Spectra Apheresis System to demonstrate substantial equivalence
  • Measured primary outcomes: the number of days to neutrophil recovery, with secondary outcome measures of CD34+ collection efficiency, MNC collection efficiency, cross-cellular contamination of platelets, red blood cells and granulocytes, and time to platelet recovery

 

U.S. Clinical Trials – Healthy Donor Study  

  • A three-center, two-arm study evaluated the Spectra Optia system for MNC collection in healthy donors
  • Characterized the performance of the Spectra Optia system in 15 G-CSF mobilized donors and 15 non-mobilized donors
  • Measured outcomes including collection efficiency, cross-cellular contamination of platelets, red blood cells and granulocytes, and MNC and CD34+ collection efficiency

 

Key Facts:

  • The MNC protocol on the Spectra Optia system has been available since July 2010 in Europe, and in select countries in the Middle East, Asia and Africa
  • The MNC protocol on the Spectra Optia system has been available in Canada since August 2011
  • Sales and support of the COBE Spectra system will continue until all protocols are available on the Spectra Optia system
  • The Spectra Optia system's Therapeutic Plasma Exchange (TPE), Red Blood Cell Exchange (RBCX) and MNC protocols are available for sale in the European Community, in Australia, and in select count ries in the Middle East and Africa; the RBCX and MNC protocols have not yet been cleared by the FDA

Key Quotes:

 

Ray Goodrich, Ph.D., Vice President, Scientific and Clinical Affairs, Terumo BCT

  • "We are thrilled to have submitted the 510(k) for the MNC collection procedure on the Spectra Optia system—ultimately benefiting patients, clinicians and laboratory processes. We look forward to collaborating with the FDA to complete any additional regulatory requirements requested for protocol release."
  • "We are committed to therapeutic apheresis through the Spectra Optia system, and will continue to provide outstanding support for the COBE Spectra system as our customers transition to the latest, most innovative platform."

Notes:

  • MNC Protocol:
    • U.S. 510(k) Pending/Not available for sale in the U.S.
    • CAUTION – Investigational Device; limited by United States law to investigational use
  • Terumo BCT cannot guarantee nor predict when or if FDA clearance may be granted

About Terumo BCT:

 

CaridianBCT and Terumo Transfusion are becoming Terumo BCT, the world leader in blood component technology. Together, we believe in the potential of blood to do even more for the world than it does today. This belief unites our organization, inspires our innovation and strengthens our collaboration with customers to ultimately benefit the patients we all serve. While the company is legally known as Terumo BCT, the integration of CaridianBCT and Terumo Transfusion will not be complete until April 2012.

 

About Terumo Corporation:  

 

Tokyo-based Terumo Corporation is one of the world's leading medical device manufacturers with $4 billion in sales and operations in more than 160 nations. Founded in 1921, the company develops, manufactures and distributes world-class medical devices including products for use in cardiothoracic surgery, interventional procedures and transfusion medicine; the company also manufactures a broad array of syringe and hypodermic needle products for hospital and physician office use. Terumo contributes to society by providing valued products and services to the health care market and by responding to the needs of health care providers and the people they serve. Terumo Corporation's shares are listed on the first section of the Tokyo Stock Exchange (No. 4543, Reuters symbol <4543.T>, or Bloomberg 4543: JP) and is a component of the Nikkei 225, Japan's leading stock index.

 

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Contact:
Laura Fusco

Global Corporate Communications

Phone: +1.303.205.2546

press@caridianbct.com