AbbeyMoor Medical Inc., a developer and manufacturer of medical devices for the management and treatment of prostatic obstruction, announced today that it has received PMA approval from the US Food and Drug Administration (FDA) for design changes to their flagship product, The Spanner Prostatic Stent.
"These changes are aimed at further improving patient comfort over the current highly accepted levels," said Darren Cook, director of marketing with the company. "Our goal is to hear an even greater percentage of our patient's state that they are not aware of the device's presence." According to Mark Whalen, VP of product development with the company, "The approved changes to the device result in a significant increase in flexibility over the current Spanner design with no impact to the ease of delivery and removal of the device."
The Spanner is a temporary prostatic stent designed to aid men who are experiencing difficulty in urination due to prostatic obstruction. Device placement can be performed in a physician office and does not require cystoscopy or anesthesia for placement. The Spanner is an alternative to indwelling catheterization, intermittent catheterization, or the use of a suprapubic tube in some patients.