Biocardia's Morph AccessPro Steerable Introducer Approved in Europe

March 17, 2014—BioCardia, Inc. (San Carlos, CA) announced it has received European CE Mark approval for the Morph AccessPro steerable introducer, which is designed for easy navigation through the vasculature during delivery of biotherapeutics and medical devices. The Morph AccessPro, which is commercially available in the United States, will be launched in the European Union in the coming months.

According to the company, the Morph AccessPro enables a physician to customize the catheter shape to an individual patient’s anatomy, allowing access to the contralateral superficial femoral artery all the way to the trifurcation, the renal arteries, and the mesenteric arteries.

Morph AccessPro’s steerable, thin-walled catheter shaft technology provides a flexible pathway for biologic delivery systems, balloon dilatation catheters, stents, guidewires, and microinfusion systems. The introducer is designed to enhance physician control and to reduce complications and catheter exchanges, thereby minimizing procedure time and radiation exposure, according to BioCardia.

“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. This introducer is valuable today to improve access for aorto-ostial procedures, thereby enhancing safety and shortening procedure times,” Rodney S. Badger, MD, commented in the company’s press release. “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 is Chief of Interventional Cardiology and Associate Professor of Medicine at the University of Utah in Salt Lake City, Utah.