Amplitude Surgical Announces Additional Regulatory Approvals in Australia

Amplitude Surgical has received additional regulatory product approvals from the Australia’s Therapeutic Goods Administration (TGA).

“On the large Australian market, which accounted for 11 percent of the group’s 2014-15 sales, we are continuing our development, and these additional approvals bode well for our future activity,” said Olivier Jallabert, Aplitude Surgical chairman/CEO. ” Beyond the innovative nature of our prostheses, these results were made possible by the work of our teams, in particular from our local subsidiary, Amplitude Australia Pty., created in 2013.”

Following the registration of the Score prosthesis, the Integrale stem and the Saturne cup in 2007 followed by the Uniscore prosthesis in 2014, Amplitude Surgical received the following approvals from the TGA:

• The entire Novastep foot product range was okayed on Sept. 24. Marketing will be carried out through an exclusive Australian distributor as soon as the prosthetic reimbursement codes are obtained, executives said.
• Approval for the Anatomic knee occurred on Aug. 3. This product range was commercially pre-launched at the AOA (Australian Orthopedics Association) congress in early October to initiate a two-year clinical trial among eight surgeons. The trial aims to assess the prosthesis’ performance in order to set a reimbursement price for private hospitals approved by Australian mutual health insurance companies. Following the first knee replacement carried out by Dr. MacDessi at Canterbury Hospital in early August, more than 40 additional joint replacements have already been undertaken.