Allied Healthcare's CardioCel used in first non-trial procedure

Allied Healthcare (ASX:AHZ) has reached a milestone with its CardioCel cardiovascular patch product, announcing its first surgical use outside of clinical trials.

The CardioCel patches were used in open-heart procedures to fix congenital heart holes in infants, conducted this week at the Mater Hospital in Brisbane.

The hospital's Professor Tom Karl conducted the first non-trial CardioCel procedures. Karl was the first surgeon to receive approval to use the patches in CHD procedures under the TGA's Authorised Prescriber Scheme in September.

Karl said CardioCel “is expected to add significant long term value to our existing surgical practice of repairing CHD and is expected to allow our patients to live a ‘normal’ life, free of implanted tissue related complications.”

Karl is one of several Australian cardiothoracic surgeons to have applied to use CardioCel in surgical procedures under the scheme.

CardioCel is produced using Allied Healthcare's ADAPT tissue engineering technology. The patches have multiple potential advantages over existing techniques, including a greatly reduced risk of calcification or toxic cell damage.

Allied Healthcare managing director Lee Rodney said the patches provide a biocompatible scaffold for native tissue repair, while still retaining tissue strength.

The company is currently seeking full TGA approval for CardioCel. The company also filed an application for CE Mark approval in June, and plans to submit one with the US FDA by late 2012 or early 2013.

Allied Healthcare (ASX:AHZ) shares were trading unchanged at $0.026 as of 2pm on Thursday.