OrthoPure® XT

OrthoPure® XT provides an easy to use, off the shelf solution that eliminates the need for 'donor site' surgery and the associated pain, facilitating faster recovery times. 

The OrthoPure® XT device is a porcine tendon graft which has been treated using a patented decellularisation processing technology (dCELL®) to remove all viable cells and native components which have the potential to elicit an immune response. This decellularisation technology gently cleanses the tissue whilst preserving the natural collagen architecture. The OrthoPure® XT is an off-the-shelf device for knee ligament reconstruction that negates the need to take tissues from the patient, or to invest in complex and costly donor procurement processes. The result is a reduction in operative time, no donor site morbidity and associated muscle strength deficiencies for the patient, no specialist storage requirements and the flexibility to have the product ready to use off the shelf at any time. The OrthoPure® XT device is a soft tissue graft that is specifically designed to be implanted using standard surgical techniques. It is compatible with standard instrumentation and with common soft tissue fixation devices for both femoral and tibial attachment. The handling properties are also comparable to commonly used soft tissue grafts (allograft or autograft).

OrthoPure® XT is available in four different sizes:

• 2405XTS Size 5, mean strength 900 N
• 2406XTS Size 6, mean strength 1’200 N
• 2408XTD Size 8, mean strength 3’500 N
• 2410XTT Size 10, mean strength 5’700 N

In a prospective, non-comparative, single-arm, multicentre study, 40 subjects were treated for primary ACL reconstruction with the OrthoPure® XT device between November 2015 and August 2016 across 8 centres in Europe (age 18–48, mean 31.9 years, 28 males, 12 females). Of the 40 subjects treated with the device, 34 remained at the 24-month follow-up. 6 subjects were terminated early: 2 lost to follow-up, 2 withdrew consent and 2 graft ruptures. 1 subject’s data was also excluded from the assessment of device performance due to a major protocol deviation. Of the data collected, the average IKDC score was 91.0 ± 9.3, compared to 54.6 at baseline. A statistically significant improvement from baseline was reported (p<0.001).

Safety and performance data for the OrthoPure® XT device at the 24-month follow-up assessments has shown that the device is safe and performs as intended and is therefore a viable alternative to other tissue grafts.

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OrthoPure® XT is distributed by Geistlich in Germany, Italy and Switzerland.

Legal Manufracturer:
TissueRegenix
Unit 3, Phoenix Court
Lotherton Way,
Garforth
LS25 2GY
United Kingdom

Website: Tissue Regenix