BioCardia has 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 optimised for larger, dilated hearts, while maintaining compatibility with smaller hearts. It also does not require biotherapeutic programmes 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.
According to a press release, 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 minimises 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 optimise 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 USA 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.”