BioCardia gets FDA clearance for catheter to guide Helix delivery system

Helix biotherapeutic delivery system
Helix biotherapeutic delivery system

BioCardia has received US Food and Drug Administration (FDA) 510(k) clearance for its Morph DNA deflectable guide catheter, used to guide the Helix biotherapeutic delivery system during CardiAMP cell therapy delivery in the heart.

A company statement explains that the Morph DNA deflectable guide catheter is designed to enhance procedural control of therapeutic catheters, such as the Helix system, during delivery of cell therapy. It is intended to provide superior ease of use through bidirectional deflection, reduced torque build up or whip, enhanced fluoroscopic visibility, and improved ergonomics. Helically-arranged pull-wires in the device, resembling the double helix of a DNA strand, increase catheter stability, rendering it virtually whipless around curves and within the heart. The device also features a new handle design with an adjustable brake for finer catheter control during procedures.

“Our investigational Helix delivery system using the original Morph technology has shown a great safety profile and has been shown to be dramatically more efficient in helping the heart retain cell therapy when compared to other leading delivery approaches,” says BioCardia chief executive officer Peter Altman in the press release. “The new Morph DNA device is an elegant product intended to further enhance the performance of our biotherapeutic delivery capabilities, and through these, our CardiAMP and CardiALLO cell therapy programs.”

BioCardia is based in San Carlos, California, and develops regenerative biologic therapies to treat cardiovascular disease. Its biotherapeutic products are CardiAMP and CardiALLO. Other products include the Helix biotherapeutic delivery system and the Morph steerable guide and sheath catheter portfolio, including the new Avance Steerable Introducer family. BioCardia outlines that it also partners with other biotherapeutic companies to provide its Helix systems and clinical support to their programmes studying therapies for the treatment of heart failure, chronic myocardial ischaemia and acute myocardial infarction.


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