NEW YORK, Feb. 17, 2011 /PRNewswire/ — Delcath Systems, Inc.
(Nasdaq:
DCTH) today announced that the Company has achieved ISO
13485:2003 Certification—an internationally recognized
quality standard designed to ensure that medical device
manufacturers have the necessary comprehensive management systems
in place to safely design, develop, manufacture and distribute
medical devices in the European Union (EU). ISO 13485 Certification
is a regulatory requirement of the EU’s Medical Device Directive,
and represents an important step toward attaining European CE Mark
approval for the Company’s proprietary Hepatic ChemoSAT™
Delivery System.
Commenting on the announcement, Eamonn P. Hobbs, CEO &
President of Delcath Systems, said, “ISO 13485 Certification
confirms that our manufacturing and quality systems meet the high
standards required of medical device companies selling into Europe,
and we are pleased to have achieved this important milestone toward
the receipt of CE Mark approval. Our technical file for CE Mark is
pending, and we continue to expect CE Mark approval for our product
in mid-2011.”
About Delcath Systems
Delcath Systems, Inc. is a specialty pharmaceutical and medical
device company focused on oncology. Delcath’s proprietary system
for chemosaturation is designed to administer high dose
chemotherapy and other therapeutic agents to diseased organs or
regions of the body, while controlling the systemic exposure of
those agents. The Company’s initial focus is on the treatment of
primary and metastatic liver cancers. In 2010,
Delcath concluded a Phase III metastatic melanoma study, and
the Company recently completed a multi–arm Phase II
trial to treat other liver cancers. The Company has not yet
received FDA approval for commercial sale of its system. For more
information, please visit the Company’s websit
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