OrthAlign, Inc., a privately held U.S.-based medical device company, announced today that it has entered into a European distribution agreement with Lima Corporate, for its award-winning Total Knee Arthroplasty (TKA) technology, KneeAlign®.
KneeAlign provides both tibial and distal femoral precision alignment in a simple, palm-sized, single-use device, providing real-time data. It is highly accurate for overall mechanical, tibial, and femoral component alignment in TKA, providing a reliable and efficient alternative to expensive Computer Assisted Surgery (CAS) systems, logistically arduous patient-specific cutting blocks, and invasive conventional methods used with an intramedullary rod. To date, KneeAlign has successfully been used in over 30,000 TKA cases, throughout the world.
“As Lima embarked on building a best-in-class platform to provide surgeons with a complete range of solutions in TKA, we were convinced that OrthAlign’s precision alignment technology should be included in our offering,” said Luigi Ferrari, Lima Corporate’s Chief Executive Officer. “OrthAlign deserves credit for its game-changing technology and we are looking forward to working together.”
Dr. André Ferreira (French orthopedic surgeon, Clinique du Parc, Lyon, France) states, “I’m very excited that OrthAlign technology will now be fully-integrated into Lima’s portfolio. KneeAlign is efficient because it provides accurate information about tibial slope and flexion-extension of the femur, which we did not have so accessible before. Varus-Valgus alignment is also beneficial because, previously, we only did valgus estimation of the femur with x-rays. KneeAlign is like CAS, but all of the data and the accuracy are now in the palm of my hand.”
In a published TKA clinical study by Denis Nam, M.D. (Washington University, St. Louis, MO), significant differences favoring the use of KneeAlign vs. CAS were found with regard to the accuracy of femoral component alignment, with 94.9% of patients in the KneeAlign cohort having an alignment within 2° of neutral vs. 92.5% in the CAS cohort. There was also a significant difference in overall mechanical alignment of the limb, with 92.5% of patients within 3° of neutral mechanical axis in the KneeAlign cohort vs. 86.3% in the CAS cohort.
In another TKA study by Dr. Nam (conducted as a randomized controlled trial, consisting of five different surgeons), it was found that KneeAlign® decreases the incidence of outliers for tibial component alignment in both the coronal and sagittal planes, and improves the surgeon’s ability to achieve a specific, intraoperative goal, compared to conventional, tibial extramedullary (EM) alignment guides in TKA. In the KneeAlign cohort, 95.7% of tibial components were within 2° of perpendicular to the tibial mechanical axis and 95% of tibial components were within 2° of a 3° posterior slope (compared to 68.1% and 72.1% in the EM cohort, respectively).
“We are pleased to partner with Lima in further expanding our award-winning KneeAlign technology to surgeons and patients throughout the European continent,” said William E. Maya, OrthAlign’s Chief Executive Officer. “There were approximately 540,000 TKAs in Europe during 2014 and this number will likely increase as the population ages, so this is a very important market for us in our international growth strategy. Lima’s forward-thinking vision in providing surgeons with a best-in-class platform of technologies resonated with us and we are honored to be a key part of the offering. Ultimately, we hope it helps to raise the standard of care throughout Europe for TKAs”.
The distribution agreement covers the European Economic Area (EEA) and Switzerland markets, excluding Romania.