THINK Surgical reaches major milestone with FDA 510(k) clearance for its TSolution One® active robot for total knee replacement
WASHINGTON, November 21, 2019 /PRNewswire/ -- MCRA, LLC (www.mcra.com) is pleased to announce that its client THINK Surgical, Inc. has obtained clearance from the U.S. 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.
· MCRA’s Regulatory Division helped THINK Surgical redesign the clinical protocol to include a single-arm study with a lower overall sample size.
· MCRA’s Clinical Research Organization (CRO) assisted the company with the operational and data management aspects of the study, which included negotiating site contracts and budgets, training the clinical research sites and monitoring the study data.
· MCRA’s Clinical team helped the sites adopt measures to achieve a 100% patient retention rate, improving the reliability of the study’s statistical outcomes.
· MCRA’s Clinical Quality team supported the study by conducting site audits and preparing the sponsor and sites for the five Bioresearch Monitoring Program (BIMO) inspections that took place once the study was concluded.
· MCRA’s Reimbursement, Health Economics & Market Access team also assisted the company with obtaining CMS approval for coverage of Medicare-eligible patients who participated in the Investigational Device Exemption (IDE) trial.
About MCRA, LLC: Founded in 2004, MCRA is a leading Clinical Research Organization (CRO) and advisory firm. MCRA's value contribution rests within in its industry experience at integrating five business value creators: regulatory, reimbursement, clinical research, healthcare compliance, and quality assurance to provide a dynamic, market leading effort from concept to commercialization. MCRA's integrated application of these key value-creating initiatives provides unparalleled expertise for its clients. MCRA has offices in Washington, DC, Manchester, CT, and New York, NY, and serves more than 600 clients globally. Its core focus areas of therapeutic experience include orthopedics, spine, cardiovascular, diagnostic imaging, wound care, dental, general healthcare, digital health, neurology, robotics and in vitro diagnostic (IVD) devices.
About THINK Surgical, Inc.: THINK Surgical, Inc. is committed to the future of orthopedic surgery and to improving patient care through the development of leading-edge precision technology. THINK Surgical, Inc. develops, manufactures and markets active robotics for hip and knee replacement surgery and maintains an open implant policy, allowing surgeons maximum choice for their patients.
Director, Clinical Business Development