Signature Orthopaedics and Halifax Biomedical Inc join forces to improve product safety through enhanced joint replacement monitoring
October 14, 2015

Australia/ Canada – October 14th, 2015 – Signature Orthopaedics, an Australian-based designer and developer of innovative medical devices and instrumentation, has teamed up with Canadian-based Halifax Biomedical Inc to offer HALIFAX monitoring to patients who receive Signature joint replacement implants. HALIFAX monitoring includes the implantation of small markers into the patient’s bone during surgery and uses HALIFAX stereo x-rays to monitor implant fixation in the first two years after a joint replacement operation. HALIFAX monitoring will be initially offered with the Signature Logical and Orgin hip replacement implant product lines.

The Orthopedic industry is constantly striving for innovation to improve patient outcomes and satisfaction. Hip and knee replacements often enjoy high success rates but sometimes new implants do not always perform as expected. Sometimes design flaws or material choices result in unacceptable rates of implant loosening. Recent implant recalls from major implant manufacturers affect thousands of patients and result in complex revision surgeries costing healthcare providers and implant manufactures hundreds of millions of dollars. These recalls undermine patient confidence and present a challenge for regulators and surgeons who want to encourage continued innovation in orthopedic implant design.

HALIFAX monitoring can help measure if a patient is having problems with implant fixation. Adding HALIFAX monitoring to an implant sale at the start of the introduction of a new orthopedic product allows orthopedic manufacturers to quickly gain insight into product performance before broad market introduction. This stepwise approach to product introduction ensures that poorly performing products are detected early, reducing the number of patients impacted.

Recognizing the need for a more rigorous method for product introduction as well as the patient benefits from more enhanced post-operative monitoring, Signature Orthopedics has opted to provide physicians and hospitals with HALIFAX implant stability monitoring for its Logical and Orign hip replacement product lines.

“Recently there have been several recalls and lawsuits associated with implant failures and loosening” says Declan Brazil, CEO of Signature Orthopaedics. “We believe manufacturers must take the lead in supporting doctors and patients with the tools to monitor implant stability for the benefit of individual patients and for the phased innovation of new products. HALIFAX monitoring technology is the most accurate clinical measurement available today to perform this task. Halifax Biomedical is a leader in providing commercial products and services in this area and we are happy to make this service available as part of our implant sale.”

“We are extremely excited to implement this approach to improve product introduction and patient monitoring with Signature Orthopaedics” said Chad Munro, CEO of HBI. “We have several Canadian and US centers already equipped with the HALIFAX monitoring solution and are planning new sites in Australia in the near future. If patients with Signature Implants are experiencing issues, surgeons can utilize these centers to perform very accurate 3D assessments to determine implant stability. We believe this approach to enhanced product surveillance will enable a new standard in safe stepwise introduction of new orthopedic implant technology while at the same time providing valuable data to Surgeons to aid in the post-operative care of each individual patient.”
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Halifax Biomedical Inc
Halifax Biomedical Inc. (HBI) is an Orthopaedic Clinical Measurements company headquartered in Nova Scotia, Canada and a leading provider of proprietary Stereo Orthopaedic Radiography (SOR) imaging technology (HALIFAX exams). HBI focuses on two clinical problems: early detection of implant loosening for hip and knee joint replacements, and quantification of instability of the spinal column in patients with chronic low back pain.

Products provided by HBI to support HALIFAX exams include surgical bead inserters, bead sets, SOR imaging equipment, and centralized image processing services. The centralized processing of joint replacement images is performed by HBI’s image analysis experts using Model-based RSA software developed by HBI’s partner RSAcore of the Leiden, The Netherlands, University Medical Center.

For more information, please visit http://halifaxbiomedical.com/, or contact:

Chad Munro, CEO
Email: Chad.Munro@halifaxbiomedical.com
Office: (902) 945-2771
Fax: (902) 945-2324

Signature Orthopaedics
Signature Orthopaedics is a contract manufacturer with its own line of total hip and knee replacements for US and Australian markets. At Signature, we take great pride in developing innovative medical devices that improve the lives of patients and surgeon performance alike. We have the experience, knowledge and resources to provide you with the solutions you need, at a quality beyond expectation.

For more information, please visit http://www.signatureortho.com.au/
Mailing Address:
7 Sirius Road,
Lane Cove West, NSW 2066
Australia