Four more surgeons cleared to use CardioCel

Four more Australian surgeons have received approval to use Allied Healthcare’s (ASX:AHZ) CardioCel cardiovascular patch in congenital heart disease.

Mater Hospital director of paediatric cardiac surgery Dr Nelson Alphonso has been granted authorisation to use CardioCel under the TGA’s Authorised Prescriber Scheme (APS).

Also securing early access are a Melbourne University team, which now have approval to use CardioCel for a clinical trial involving up to 40 patients.

The first surgeon to receive APS authorisation for CardioCel was Mater Hospital’s Professor Tom Karl. He had applied to use Cardiocel in procedures to treat and repair congenital heart defects in children.

Professor Karl secured approval in September 2012 and used the patches in open-heart procedures the following month, marking the first time CardioCel had been used outside of clinical trials.

Announcing the new approvals, Allied Healthcare managing director Lee Rodne said several other Australian surgeons are awaiting approval for their own APS applications to use CardioCel.

“There are a number of surgeons in Australia that see the clinical benefits of CardioCel and a growing number of these have been working within their institutions to find a way to gain early access,” he said.

CardioCel is a patch designed to repair paediatric heart deformities. It is produced using Allied Healthcare’s ADAPT tissue engineering technology.

Allied Healthcare is seeking TGA approval to market the device in Australia and has also applied for CE Mark certification in Europe.

Allied Healthcare shares were trading 3.57% higher at $0.029 as of around 1.30 pm on Monday.