New CE Mark for Stem Cell Catheter Means Transendocardial Therapy in Larger, Dilated Hearts

Cardiovascular regenerative medicine company BioCardia®, Inc., has gained CE Mark approval for its Helix 953L Catheter as part of its Helix Transendocardial Delivery System for infusion of biologics to the heart.


We’ve followed BioCardia before, most recently reporting favourable clinical results in November 2013, here. The company is focusing on the intramyocardial delivery of bone marrow-derived stem cell preparations to heart muscle that has been damaged by a heart attack or other sources of myocardial ischemia, the essence of the system lying as much in the delivery system as in the stem cells.

BioCardia’s newly CE marked 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 the 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.

Company comments

“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.”

Regulatory status

Having received the CE Mark, the Helix Transendocardial Delivery System 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.

Source: BioCardia, Inc.

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