Medacta has received clearance from the U.S. Food and Drug Administration (FDA) for its MyHip(R) Planner and MyHip(R) Verifier, after recently receiving CE marking and approval from Australia’s Therapeutic Goods Administration (TGA) and from the Japanese Ministry of Health, Labour and Welfare (MHLW). These two promising innovative technologies will be introduced into all markets in which Medacta operates in the upcoming months.
MyHip Planner and MyHip Verifier are two personalized solutions which are intended to be used in primary total hip replacement for 3D pre-operative planning and intra-operative verification. Designed to predict and minimize surgical complexity, as well as to improve overall surgical outcomes and patient satisfaction, these applications can be used as stand-alone tools or together, and are intended to deliver a personalized approach to total hip arthroplasty (THA), optimizing the surgical experience.
MyHip Planner is a surgeon-operated CT-based software which allows the user to create a patient-specific pre-operative 3D plan. Through an automatic and precise 3D reconstruction of the patient’s anatomy and the real time post-operative dynamic simulation of the range of motion in everyday activities based on an advanced impingement detection algorithm, this software allows the surgeon to tailor implant choice and position to the patient’s anatomy, hip joint biomechanics, and functional needs. MyHip Planner eases and empowers the critical decision-making process in defining the optimal surgical strategy for each patient. A streamlined protocol assists the surgeon when executing a 3D anatomical assessment of the anatomy and planning for the optimal implant and position within the hip joint. This helps anticipate potential intra-operative complications, such as femoral fracture and leg length inequality, or detect potential risks of implant failures, such as impingement, reduced range of motion (ROM) and overall joint instability.
When talking about MyHip Planner, Dr Lachlan Milne (MBBS FRACS), orthopaedic surgeon at Hollywood Consulting Centre in Nedlands, Western Australia, and member of the expert surgeon panel that collaborated with Medacta to develop the MyHip Planner and MyHip Verifier platforms, says: ‘MyHip Planner has revolutionized my approach to hip arthroplasty, by allowing a personalized solution to be created for each individual patient based on their anatomy, in order to suit their functional demands. This innovative platform has improved the accuracy and efficiency of surgery and has become an essential part of my practice.’
MyHip Verifier is an easy-to-use, non-invasive surgical platform that uses intra-operative fluoroscopic images to assist the surgeon in verifying patient-specific implant positioning. Engineered to integrate seamlessly into the surgeons’ existing workflow and preserving operating room efficiency, MyHip Verifier empowers intra-operative fluoroscopy by providing a real time numerical evaluation of the actual influence of implant positioning on the patient’s anatomy. By allowing the evaluation of crucial parameters for patient satisfaction, such as leg length, offset and cup position, MyHip Verifier enables physicians to make decisions about component positioning, potentially improving THA clinical outcomes and long-term patient well-being. MyHip Verifier may lead to increased confidence and reproducibility, while potentially reducing surgical outliers and improving surgical outcomes, particularly with respect to common complications, such as leg length discrepancy, unusual hip joint laxity, and dislocation.
‘MyHip Verifier is a time-neutral tool allowing an accurate intraoperative analysis of the surgical reconstruction. When combined with MyHip Planner, it is a powerful tool to ensure that the plan has been successfully executed, providing optimal surgical outcomes for my hip replacement patients,’ concludes Dr Milne.
MyHip Planner and MyHip Verifier are part of the MySolutions Platform, Medacta’s personalized medicine offering, which also includes MyHip 3D printed patient-specific guides, POP(R) – Patient Optimized Pathway and MyClinical Data. Together with a comprehensive implant portfolio, the AMIS(R) Experience, and a dedicated medical education program organized by Medacta’s M.O.R.E. Institute, MyHip Planner and MyHip Verifier empowers Medacta’s holistic approach to personalized medicine in hip arthroplasty.
Francesco Siccardi, CEO of Medacta says: ‘With our new MyHip Planner and MyHip Verifier, Medacta is enriching its integrated digital ecosystem, according to our holistic approach to personalized medicine. Our goal is to bring value at every step throughout the entire treatment journey, while supporting surgeons to improve patient outcomes and maximizing value for the healthcare system. Our ecosystem of personalized and highly technological solutions will be soon enhanced with our new NextARTM augmented reality-based surgical platform, which we have recently launched for total knee arthroplasty, and which we are working to integrate in our hip portfolio.’