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Apheresis News Volume 1.0

Apheresis News facilitates the exchange of information and resources between members of the global apheresis community by providing a website portal and a free, monthly e-newsletter dedicated to the latest information affecting apheresis.
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October 18, 2006  // Volume 1.0
WELCOME

Dear Reader,

Welcome to the inaugural issue of Apheresis News!

The purpose of this e-newsletter is to provide you with timely, useful information about the field of apheresis. Anyone can sign up to receive Apheresis News-there is no cost to subscribe. Starting November 1, 2006, Apheresis News will be published monthly.

For more information about the launch of Apheresis News, click here.

We welcome your feedback and invite you to participate by submitting news that you would like to share with other members of the apheresis community.

Sincerely,
The Apheresis News Team

TOP STORY

Proposed Decision Memo for Extracorporeal Photopheresis (CAG-00324R)
The Centers for Medicare and Medicaid Services (CMS) proposes that extracorporeal photopheresis is reasonable and necessary for: patients with acute cardiac allograft rejection whose disease is refractory to standard immunosuppressive drug treatment; and patients with chronic graft versus host disease whose disease is refractory to standard immunosuppressive drug treatment. CMS proposes that extracorporeal photopheresis is not reasonable and necessary for the treatment of bullous pemphigoid and pemphigus vulgaris. All other indications remain non-covered.

SCIENCE

Five Studies on Aquapheresis(TM) Therapy Presented at Heart Failure Society of America Annual Meeting
These studies expand knowledge on the benefits of fluid removal by CHF Solutions' Aquadex FlexFlow(TM) System.

Nephros Announces Positive Results of Clinical Study for Olpur MD190 Mid-Dilution Hemodiafiltration Filter
Nephros, Inc. announced the positive results of a recent pilot clinical study confirming that the Company's proprietary end stage renal disease ("ESRD") therapy, Mid-Dilution Hemodiafiltration ("HDF"), is an effective alternative to standard HDF, offering superior clearance of certain toxins from the blood and improving quality of life for patients with ESRD.

Verax Biomedical Initiates Two External Clinical Trials
Verax Biomedical, Inc., a leading developer of rapid tests for detecting bacterial contaminants found in blood cells and tissue, has initiated an external clinical trial of its Platelet PGD(R) Test at University Hospitals Case Medical Center and at the Cleveland Clinic.

Celibate Gay Men Will be Able to Donate Blood
The South African National Blood Service will allow gay men, who have been celibate for six months, to donate blood from November 1.

Mapping May Shorten Hunt for Veins
Healthcare workers who handle patients with hard-to-find veins are getting a little help from a new device that offers something like X-ray vision to make precise needle sticks.

Positive Preclinical Data on Vascular Wrap(TM) Presented at Vascular Conference
Angiotech Pharmaceuticals, Inc. today announced positive preclinical data related to its Vascular Wrap(TM) paclitaxel-eluting mesh and Lifespan(R) graft technology platform.

Automated Technique Accurately Measures Platelet Counts in "Platelet Gel" Products
A special blood concentrate known as platelet-rich plasma (PRP) can promote healing in a wide range of medical and surgical situations, but research has been limited by the lack of a universally accepted approach to measuring the platelet concentrations contained in PRP.

FDA Clears Spire Long-term Dialysis Catheters
The U.S. Food and Drug Administration gave Spire Corp. clearance to market the company's silver-coated hemodialysis catheters, Spire has announced.

Polycarbonate Adsorber Housings from DALI Adsorber System
The Bad Homburg, Germany-based medical technology company Fresenius Medical Care has developed a new technology called DALI(R) (Direct Adsorption of LIpoproteins) especially for the treatment of patients with severe lipometabolic disorders. For the housing of the adsorber system, a fracture-resistant plastic was required. In the end, the first choice was Bayer's Makrolon(R) 2458.

All Intravascular Devices Pose Risk of Bloodstream Infection to Patients
All types of intravascular devices pose a risk of bloodstream infection to exposed hospitalized adult patients, finds a study published in the September issue of Mayo Clinic Proceedings. What's more, IVDs have become the leading cause of bloodstream infections in health care settings in the United States and worldwide.

Aethlon Medical Reports on Landmark Human Study
Safety and viral capture has been documented in health compromised hepatitis-C patients.

ABSTRACTS, REVIEWS & SPECIAL REPORTS

Blood Transfusion-transmitted Infections: A Global Perspective
Thanks to the many blood-safety interventions introduced since 1984, the overall risk for most transfusion-transmitted infections has become exceedingly small. In the September 28 issue of the New England Journal of Medicine, Canadian medical experts put into perspective the continuing risk of transfusion-transmitted infections as well as the possible safety interventions that might reduce that risk even further.

BUSINESS

Baxter Announces Sale of Transfusion Therapies Business to Texas Pacific Group
Baxter International Inc. has announced that it has entered into a definitive agreement to sell its Transfusion Therapies business to Texas Pacific Group for $540 million.

Gambro BCT Selects Camstar's Medical Device Suite for Global Deployment
Camstar announced that Gambro BCT, a world leader in automated blood collections, therapeutic apheresis and cell therapy, has selected Camstar's Medical Device Suite to manage Device History Records, ensure process enforcement and facilitate regulatory compliance.

Anormed and Genzyme Reach Agreement on Acquisition
Genzyme Corporation and AnorMED Inc. have announced that they have executed a mutually beneficial support agreement under which Genzyme will acquire AnorMED in an all cash transaction valued at US$13.50 per outstanding share, or approximately US$580 million.

Fresenius Receives Tax Incentive
The state of Utah has thrown its support behind a planned expansion of the Fresenius Medical Care plant by approving a $3 million tax incentive for the company.

Red Cross Assures Public Blood is Safe
Nearly a month after the American Red Cross was fined 4.2 million dollars for violating blood-safety laws, the organization is still trying to assure the public. They insist the nation's blood supply is safer than ever.

Approval of Forensol in the United Kingdom Triggers US $3 Million Payment to Anormed
Canadian drug maker AnorMed Inc. has announced that Shire Pharmaceuticals will pay it $3 million after Shire got licensing approval in Germany to sell AnorMed's Forsenol, a treatment used in association with dialysis.

NeoStem Signs First Adult Stem Cell Collection Center Agreement
NeoStem, Inc. has announced the signing of its first collection center agreement with Ron Rothenberg MD, FACEP.

Aksys Receives Prototype of New Home Hemo Machine
Aksys Ltd. announced last week that it had received a prototype of the G-2 system, which will be the follow up to the company's PHD home hemodialysis system.

Blood Service is Suspended in Lab Probe
Blood bank service at a Highland hospital has been suspended after an inspection revealed deficiencies in its analytical laboratories.

Plan to Put Blood Donors on Standby
A new scheme to create a special group of blood donors on standby to donate within 24 hours during shortages has been launched.

Lawsuits Allege Fraud and Negligence in Stem Cell Treatment
The leaders of a Kansas City treatment program say they provide "excellent" care to their patients, but lawsuits allege that a period of failings led to suffering and death.

FUNDING & PROGRAMS

International Woman in Transfusion Award
AABB, the BBTS and ISBT have established this unique award to honor women for lifetime achievements in transfusion medicine and science.

American Society for Apheresis Best Abstract Award
Ten awards valued at $1500 each will be awarded to ASFA members and non-members.

REGULATORY

CENTERS FOR MEDICARE AND MEDICAID SERVICES (United States of America)

Deal On Medicare Physician Payments Likely This Year
House Energy and Commerce Committee Chair Joe Barton has said that Congress before the end of the year likely will reverse a 5.1% reduction in Medicare physician reimbursements scheduled to take effect in January 2007.

Transcript for 9/26/06 NPI Roundtable Now Available

US DEPARTMENT OF HEALTH AND HUMAN SERVICES (United States of America)

HRSA Awards $50 Million to Improve and Promote Transplantation
The Health Resources and Services Administration, part of the U.S. Department of Health and Human Services, recently awarded funds totaling almost $50 million to support a variety of activities meant to improve and encourage organ, tissue, bone marrow, cord blood and circulating blood stem cell donations.

Advisory Committee on Blood Safety and Availability

FOOD AND DRUG ADMINISTRATION (United States of America)

Hospitals Will have to Report their Reuse of Devices
Hospitals will soon be required to submit reports on single-use medical devices that are being reprocessed and then used again on patients, rather than thrown away.

Guidance for Industry: Recognition and Use of a Standard for Uniform Blood and Blood Component Container Labels

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Proposed Collection; Comment Request; Guidance for Industry on Submitting and Reviewing Complete Responses to Clinical Holds

Guidance for Industry: Bar Code Label Requirements - Questions and Answers

Guidance Emphasizing Responsibilities of HCT/P Facilities When Establishing Manufacturing Partnerships

Approved Biological Premarket Approval (PMA) Device Applications - Update

Review of Agreements, Guidances, and Practices Specific to Assignment of Combination Products in Compliance With the Medical Device User Fee and Modernization Act of 2002; Request for Comments

Medical Devices: Premarket Approval Applications, List; Safety and Effectiveness Summaries Availability

MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (United Kingdom)

Medical Device Alerts

Field Safety Notice: Infusion & Transfusion: Administration Set - Baxter Healthcare Ltd - Administration Set - Continu-Flo Solution Sets with Check Valve

Field Safety Notice: Haemodialysis Blood Line - B Braun Medical Ltd - Arterial/Venous Blood Line - 7210697

Field Safety Notice: Dialysis Machine - Gambro Rostock - TERAKLIN MARS Treatment Kit - 1112/0, 1112/1, 115/1 & 1412/1

Field Safety Notice: Machine Dialysis - Gambro Renal - Prismaflex Continuous Renal Replacement System

Field Safety Notice: Heamofiltration Machines - Edwards LifeSciences - Aquarius

Field Safety Notice: Haemodialysis Machine - Gambro Renal - Prisma Continuous Renal Replacement System

THERAPEUTIC GOODS ADMINISTRATION (Australia)

Abridged Assessments for Medical Devices Previously Registered or Listed in the Australian Register of Therapeutic Goods (ARTG)


For Country-Specific & International Regulatory Resources, Including Regulatory Agencies Such As the FDA, EMEA, & More Please Visit The Regulatory Page On The Apheresis News Website at http://www.apheresisnews.com/resources/regulatory/

ASFA

American Society for Apheresis (ASFA) Annual Meeting: April 18-21, 2007 in Nashville, TN

Call for Abstracts
Abstracts will be accepted beginning: OCTOBER 18, 2006
Abstract Submission Deadline: JANUARY 8, 2007

FEATURED EVENT

AABB Annual Meeting and TXPO
Miami Beach, Florida
October 21-24, 2006

For further event information, click here.

WEBSITE PREVIEW

The Apheresis News website features information on apheresis events, publications, regulatory bodies, associations, products, and jobs. Please visit www.apheresisnews.com to access these resources.

EVENTS

American Society of Nephrology Renal Week
The November 14-19
San Diego, USA

American Society of Hematology 48th Annual Meeting and Exhibition
December 9-12
Orlando, USA

JOURNALS

American Journal of Nephrology
"The fast-track publication in basic nephrology."

Journal of Clinical Apheresis
"The Journal of Clinical Apheresis publishes articles dealing with all aspects of hemapheresis."

This newsletter is intended to be a useful and timely reference for those working or interested in apheresis. Because of the constantly changing nature of the Internet, some of the website links included herein may change without notice.
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