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BioCardia Inc. has received the European Union’s CE mark for its Helix 953L catheter as part of the Helix Transendocardial Delivery System for infusion of biologics to the heart. The new catheter is developed for larger, dilated hearts, while maintaining compatibility with smaller hearts, according to the company. 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 used for the 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, BioCardia officials claim. A helical-shaped needle screws into the myocardium for 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 Peter Altman, CEO of the San Carlos, Calif.-based firm. “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 already has received the CE mark and is available in the European Union. It is currently being used for investigational biotherapeutic programs in the United States and is not approved for sale by the U.S. Food and Drug Administration. BioCardia develops regenerative biologic therapies to treat cardiovascular disease. 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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