BioCardia has obtained CE Mark approval in the EU for its Helix 953L catheter as part of its Helix transendocardial delivery system for infusion of biologics to the heart.
The Helix 953L catheter, which is compatible with smaller hearts, has been optimised for larger, dilated hearts.
According to BioCardia, the new catheter does not require biotherapeutic programmes already using the Helix system for delivery to develop new compatibility data.
The company’s Helix 953L catheter will be commercially available in the EU in the coming months.
BioCardio CEO Peter Altman said: "We possess deep experience in this field, including extensive clinical experience in the US 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."
BioCardia’s Helix biotherapeutic delivery catheter system enables delivery of biologic therapies to the heart muscle from within the chamber of the heart.
The two-catheter system enables local delivery of cell and gene based therapies to treat heart failure, myocardial infarction, ischemia, and cardiac conduction disorders.
The catheter features a steerable catheter design, which reduces the risks associated with navigating within the heart, as well as reducing procedure times.
A helical-shaped needle of the device 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 under investigational use in the US.