BioCardia out of San Carlos, California has received European CE Mark approval for its Helical Infusion System for “non-surgical intramyocardial cell, gene, and protein therapy options for patients suffering from the effects of heart failure and chronic myocardial ischemia.” The package consists of a Morph Universal Deflectable Guide catheter and the Helical Infusion Catheter that can be used in any standard cath lab.
Advantages of the system from the product page:
Stable delivery platform
• control delivery depth
•control rate of deliveryEase of confirmation of location and delivery Minimizes chance of perforation Minimizes back leak Helical fluid pathway is self sealing Fixation enables flushing of agents with another passive solution for redistribution No capital equipment costs; minimal device costs Second lumen allows fluoroscopic imaging without contaminating therapeutic Over the wire left ventricular access Flexible distal coil reduces potential tissue trauma Extensive history of helix geometry anchoring in myocardium
Product page: Helical Infusion Catheter …
Press release: BioCardia Announces CE Mark Approval of the First Stand-alone Intramyocardial Stem Cell Delivery Catheter System …
Article from a 2006 issue of Nature Clinical Practice Cardiovascular Medicine describing the system: Catheter-based delivery of cells to the heart (.pdf)
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