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San Carlos, Calif.-based BioCardia Inc. has received the CE mark for its Helix 953L catheter as part of the Helix Transendocardial Delivery System for infusion of biologies to the heart.

San Carlos, Calif.-based BioCardia Inc. has received the CE mark for its Helix 953L catheter as part of the Helix Transendocardial Delivery System for infusion of biologies 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.
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Title Annotation:Recent CE Mark Approvals
Publication:Medical Product Outsourcing
Date:Mar 1, 2014
Words:152
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