Updated on 6 March 2013
Allied Healthcare is preparing for a CE Mark approval of CardioCel for its global launch
Singapore: Allied Healthcare's CardioCel implants has shown no calcification four years after being implanted. Patients involved in an ongoing phase II extension study were assessed four years after their congenital heart defect was repaired using CardioCel.
The assessment found no sign of calcium build up at the site of repair, a result also seen when the same patients were reviewed three years after surgery. The company said it will continue to monitor these patients.
"Four years without calcification when typically it is seen within six months post-surgery with existing marketed products is a significant result for us," said Mr Lee Rodne, managing director, Allied Healthcare. "This provides additional positive data on CardioCel and its potential to prevent repeated surgeries for patients with heart disease."
Allied Healthcare is now preparing for a CE Mark approval in Europe as part of its global launch of the product. The company also expects to file a 510(k) marketing approval submission with the FDA in the near future. CardioCel is currently being used in Australia at the Mater Hospital in Brisbane under the Authorised Prescriber Scheme (APS) with other major hospitals expected to gain access through APS in the near future.
"CardioCel with its anti-calcification profile, regenerative properties and ease of handling has many advantages over existing tissue products used in surgery and offers surgeons, and patients, the real opportunity for reduced interventions in their long-term management," said Mr Bob Atwill, group executive and CEO of the company's regenerative medicine division.