Conformis announced completion of the first two Conformis Hip System implants. The Conformis Hip System is a 3D designed primary total hip replacement system. The first surgeries were performed by Gregory Martin, M.D., Joint Fellowship Trained Orthopedic Surgeon and founder of Personalized Orthopedics of the Palm Beaches, and took place at JFK Medical Center in Atlantis, Florida on July 31, 2018.
“Partnering with our expert surgeon design team and leveraging our extensive experience in automated 3D printing and additive manufacturing enabled us to bring a revolutionary new hip replacement system to market. Our 3D implant design process provides surgeons with interactive input and improves operational efficiencies compared to 2D templating. The design process produces specific individualized pre-navigated cutting guides and implants. A groundbreaking acetabular reaming system has also been developed,” said Mark Augusti, chief executive officer and president of Conformis. “With this launch, we expect to lead the way in innovative solutions for the $7B hip replacement market by providing surgeons with game-changing operative solutions to better serve them and their patients both in hospitals and ambulatory surgical settings.”
Similar to the design process for the Conformis Knee technologies, the Conformis Hip System uses proprietary advanced imaging and design software, to design, manufacture and deliver the suite of FDA-cleared patient conforming Knee and Hip replacement implants. After each patient’s CT scan is converted into a 3-dimensional computer model, the unique measurements of each patient’s anatomy are transformed into a comprehensive, individualized, pre-operative surgical plan that is delivered to the surgeon well in advance of the operation. Surgeons are able to collaborate with Conformis during the planning process in order to design the optimal Hip System for each patient based on surgeon preferences.
“The Conformis Hip System is designed to address many of the short comings of primary hip replacement today. For the first time, orthopedic surgeons have a fully-guided system designed to address the wide variations in anatomy presented across our cases,” said Dr. Martin M.D, a member of the surgeon design team and Conformis consultant. “The Conformis system builds upon traditional methods for hip replacement surgery with proven materials and components which, today, are offered in only limited standard configurations. Due to the accuracy of the personalized pre-operative surgical plan, the 3D printed patient conforming cutting guides and hip implant components, my hope is that with the new Conformis Hip system, surgeons will be able to improve both patient outcomes and operational efficiencies.”
Each component of the Conformis Hip System is pre-navigated to fit the patient, with certain components designed specifically for that patient. The Conformis Hip System is delivered directly to the hospital or surgery center in a single patient-labeled kit, eliminating the need for excess inventory. Patient conforming, single-use, 3D printed cutting guides are also included, limiting the need for the vast amount of reusable instruments required for a standard off-the-shelf total hip replacement.
The first two Conformis Hip System surgeries were conducted as part of a limited launch. Timing for a complete commercial launch is expected to be announced in 2019.