US-based BioCardia has obtained CE Mark approval for its Helix 953L catheter as part of its Helix transendocardial delivery system for infusion of biologics to the heart.
BioCardia has optimized the Helix 953L catheter for larger, dilated hearts. The new catheter, which is also compatible with smaller hearts, does not require biotherapeutic programs already using the Helix system for delivery to develop new compatibility data.
The company will launch the Helix 953L catheter in the EU in the coming months.
BioCardio CEO Peter Altman noted 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.
"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," Altman added.
BioCardio’s Helix transendocardial delivery system, a two-catheter system, enables delivery of biologic therapies to the heart muscle from within the chamber of the heart.
The system features a steerable catheter design which reduces the risks associated with navigating within the heart, as well as 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 transendocardial delivery system is currently an investigational device in the US and is not approved for sale in the country.