HINK Surgical engaged MCRA to provide clinical study management support for the pivotal study, as well as assist with preparing and submitting their IDE to FDA
MCRA announced that its client THINK Surgical has obtained clearance from the US Food and Drug Administration (FDA) to market the TSolution One Total Knee Application for use in total knee arthroplasty (TKA) in the United States.
THINK Surgical engaged MCRA to provide clinical study management support for the pivotal study, as well as assist with preparing and submitting their IDE to FDA. MCRA is a leading medical device advisory firm and Clinical Research Organization (CRO) integrating U.S. and international regulatory, clinical research, reimbursement, healthcare compliance, and quality assurance consulting services.
“I’d like to thank the team at MCRA for their expertise and support in the successful completion of this groundbreaking clinical trial,” said John Hahn, CEO and President of THINK Surgical, Inc. “MCRA’s in-depth understanding of clinical studies and regulations helped to achieve U.S. FDA clearance of TSolution One® Total Knee Application.”
Iman Ahmad, Director of Clinical Affairs at MCRA, added, “The clinical trial results clearly demonstrated that THINK Surgical’s TSolution One® System is going to revolutionize orthopedic care for patients in the U.S. It has been an honor for MCRA to participate in planning and conducting this study, and to witness this milestone clearance.”
The TSolution One® Total Knee Application includes CT-based 3D pre-surgical planning software, which allows surgeons to design and prepare, in a virtual environment, the patient’s unique knee joint replacement plan using a choice of knee implant options. During total knee replacement surgery, the surgeon implements the patient’s pre-planned procedure using the active robot, which prepares the joint according to the surgeon’s plan for precise placement of knee implants. The device was previously CE marked and has been actively marketed in Asia Pacific and Europe.
Five surgeons participated in the clinical trial, which confirmed the safety and effectiveness of the TSolution One® total knee application compared to traditional knee replacement using manual surgical instrumentation. Study enrollment began in 2017 and was completed in December 2018. Data collection was completed in 2019 with 100% retention of the 115 enrolled patients.
MCRA’s inter-disciplinary service model helps its clients seamlessly overcome all of the regulatory and operational hurdles that occur during a clinical trial, and is what distinguishes MCRA from other CROs.
Source: Company Press Release