Delcath Systems Achieves Medical Device Regulation Certification for CHEMOSAT® in Europe
March 02 2022 - 4:01PM
Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology
company focused on the treatment of primary and metastatic cancers
of the liver, is pleased to announce that on February 28 its
CHEMOSAT Hepatic Delivery System received Medical Device Regulation
(MDR) certification under the new European Medical Devices
Regulation [2017/745/EU]. Since April 2012, Chemosat had been
certified under a previous regulation, the Medical Device Directive
[2007/47/EC] (MDD), which is being replaced by MDR.
Achieving MDR certification entails a detailed evaluation from a
designated EU Notified Body, including an audit of quality systems
and a review of documentation supporting safety and performance
claims for the device. MDR greatly expands upon existing MDD
requirements including the level of clinical evidence supporting
claims, post-marketing surveillance, database traceability, unique
device identification (UDI) and increased supply chain oversight.
Under MDR, CHEMOSAT’s designation has changed from a Class IIb to a
Class lll medical device.
About Delcath Systems, Inc.
Delcath Systems, Inc. is an interventional oncology company
focused on the treatment of primary and metastatic liver cancers.
The company’s proprietary percutaneous hepatic perfusion (PHP)
system is designed to administer high-dose chemotherapy to the
liver while controlling systemic exposure and associated side
effects. In the United States, the PHP system is being developed
under the tradename HEPZATO KIT (melphalan hydrochloride for
injection/hepatic delivery system), or HEPZATO, for the treatment
of metastatic ocular melanoma (mOM), also known as metastatic uveal
melanoma (mUM) and is considered a combination drug and device
product regulated by the United States Food and Drug Administration
(FDA).
In Europe, the PHP system is now regulated as a Class lll
medical device and is approved for sale under the trade name
CHEMOSAT Hepatic Delivery System for Melphalan, or CHEMOSAT, where
it has been used at major medical centers to treat a wide range of
cancers of the liver.
Contact:
Delcath Investor Relations
Email: investorrelations@delcath.com
Hayden IR
James
Carbonara(646)-755-7412james@haydenir.com
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