BioCardia announced receipt of the CE mark for its Morph AccessPro steerable introducer, designed for easier navigation through the vasculature during delivery of biotherapeutics and medical devices.
The steerable thin-walled catheter shaft technology provides a flexible pathway for biologic delivery systems, balloon dilatation catheters, stents, guidewires and micro infusion systems. The unique introducer is designed to enhance physician control, and reduce complications and catheter exchanges, minimising procedure time and radiation exposure. It will be commercially available in the European Union in the coming months.
“Many times, the primary reason for failure of a particular procedure is the inability to gain access into the aortic branches with a guide catheter or guide sheath,” says Rodney S Badger, chief of Interventional Cardiology and associate professor of medicine for the University of Utah. “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.”
According to BioCardia, the Morph AccessPro enables a physician to customise 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.
The Morph AccessPro is currently being used commercially in 350 US hospitals and has been used in thousands of cases to date.