|[January 10, 2014]
BioCardia Receives CE Mark for New Helix™ Transendocardial Delivery Catheter
SAN CARLOS, Calif. --(Business Wire)--
Inc., a leader in cardiovascular regenerative medicine, today announced
receipt of the CE Mark for its Helix 953L Catheter as part of its Helix
Transendocardial Delivery System for infusion of biologics to the
heart. The new catheter is optimized for larger, dilated hearts, while
maintaining compatibility with smaller hearts. It also does not require
biotherapeutic programs already using the Helix system for delivery to
develop new compatibility data. The Helix 953L catheter will be
commercially available in he European Union in the coming months.
The Helix Transendocardial Delivery System is a steerable, two-catheter
system that enables delivery of biologic therapies to the heart muscle
from within the chamber of the heart. The catheter design minimizes the
risks associated with navigating within the heart, while reducing
procedure times. A helical-shaped needle screws into the myocardium for
stable delivery, and contrast delivered from the needle confirms
engagement with targeted tissue.
"The Helix system was initially designed to optimize safety, ease of use
and efficiency in delivering biologic therapy where the heart needs it
the most," said BioCardio Chief Executive Officer Peter Altman. "We
possess deep experience in this field, including extensive clinical
experience in the U.S. with this new product. The Helix 953L catheter is
another step towards our goal of a family of synergistic products
providing therapeutic solutions in cardiovascular regenerative medicine."
The Helix Transendocardial Delivery System has received the CE Mark and
is commercially available in the European Union. It is currently being
used for investigational biotherapeutic programs in the United States
and is not approved for sale in the U.S.
BioCardia, Inc., headquartered in San Carlos, CA (News - Alert) is a privately held
company developing regenerative biologic therapies to treat
cardiovascular disease. The Company's current products include the
Helix™ Transendocardial Delivery System and the Morph® steerable guide
and sheath catheter portfolio. BioCardia also partners with other
biotherapeutic companies to provide its Helix Systems and clinical
support to their programs studying therapies for the treatment of heart
failure, chronic myocardial ischemia and acute myocardial infarction.
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