Biocardia Announces FDA Clearance for Morph DNA Deflectable Guide Catheter

World News: . []

SAN CARLOS, Calif., Jan. 14, 2020 (GLOBE NEWSWIRE) --  [OTC: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Morph DNA deflectable guide catheter used to guide the Helix™ Biotherapeutic Delivery System during CardiAMP™ cell therapy delivery in the heart.

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.

“The Morph DNA deflectable guide enables navigation within the cardiac chambers without building up torque. This is hugely beneficial for controlling the delivery of therapeutic catheters, such as Helix. The ergonomic features simplify the handling and can reduce procedural delays,” said Gerald Koenig, MD, PhD, cardiologist and principal investigator of the CardiAMP Heart Failure Trial at Henry Ford Health System.

“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,” said BioCardia CEO Peter Altman, PhD. “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.”

We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardia’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 9, 2019, including those under the caption titled “Risk Factors.” BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.

More news and information about BioCardia, Inc.

Published By:

Globe Newswire: 13:00 GMT Tuesday 14th January 2020

Published: .

Search for other references to "biocardia" on SPi News


Share

Previous StoryNext Story

SPi News is published by Sector Publishing Intelligence Ltd.
© Sector Publishing Intelligence Ltd 2020. [Admin Only]
 
Sector Publishing Intelligence Ltd.
Agriculture House, Acland Road, DORCHESTER, Dorset DT1 1EF United Kingdom
Registered in England and Wales number 07519380.
 
Privacy Policy | Terms and Conditions | Contact Us