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BioCardia obtains CE Mark approval for Morph AccessPro steerable introducer

BioCardia has obtained CE Mark approval for its Morph AccessPro steerable introducer, designed for easier navigation through the vasculature during delivery of biotherapeutics and medical devices.

The thin-walled Morph AccessPro steerable introducer is intended to provide a pathway through which medical instruments, such as balloon dilatation catheters, stents, guidewires and micro infusion systems may be introduced into the peripheral vasculature.

By reducing complications and catheter exchanges, the Morph AccessPro steerable introducer enhances physician control. The device minimizes the procedure time and radiation exposure.

It enables a physician to customize the catheter shape to an individual patient’s anatomy, allowing access to the contra-lateral superficial femoral artery all the way down to the trifurcation, the renal arteries and the mesenteric arteries.

University of Utah Associate Professor of Medicine and Interventional Cardiology chief Dr Rodney S Badger noted this introducer is valuable today to improve access for aorto-ostial procedures, thereby enhancing safety and shortening procedure times.

"It also has future potential to enhance biotherapeutic interventions for diseases of the organs fed by these arteries, such as inflammatory bowel diseases, renal diseases, and even diseases involving the pancreas," Dr Badger added.

Currently, the Morph AccessPro steerable introducer is being used commercially in 350 US hospitals and was used in thousands of cases to date. It will be commercially available in the EU in the coming months.