BioCardia has received CE Mark approval for its Morph AccessPro steerable introducer, designed for easier navigation through the vasculature during delivery of biotherapeutics and medical devices.
Incorporating the thin-walled catheter shaft technology, Morph AccessPro provides a flexible pathway that medical instruments such as balloon dilation catheters, stents, guidewires and micro infusion systems may be introduced into the peripheral vasculature.
BioCardia has designed the steerable introducer to enhance physician control, and reduce complications and catheter exchanges. The device minimises procedure time and radiation exposure.
According to BioCardia, the currently available guide catheters have pre-formed distal curves shaped similar to a hockey stick or a shepherd's crook designed to manoeuvre within specific vascular anatomical configurations.
In general, the access could be difficult and prolonged to attain if a patient's anatomy is complicated and does not match the catheter shape.
Through the Morph AccessPro steerable introducer, physicians can customise the catheter shape to an individual patient's anatomy. This allows 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 said: "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."
The company is currently planning to launch the Morph AccessPro steerable introducers in the EU in the coming months.
The Morph AccessPro is currently being used commercially in 350 US hospitals and has been used in thousands of cases to date.
BioCardia's current products include the Helix transendocardial delivery system and the Morph steerable guide and sheath catheter portfolio.