CE Mark for TKA TSolution One System
Elizabeth Hofheinz, M.P.H., M.Ed. • Thu, December 28th, 2017
Fremont, California-based THINK Surgical Inc. has announced that the European Authority had awarded the CE Mark to TSolution One Surgical System for total knee arthroplasty (TKA).
"We are pleased to offer one of the most advanced technologies in Total Knee Replacement through the TSolution One Surgical System to the European market and other countries that rely on the CE Mark," said John Hahn, CEO of THINK Surgical, Inc.
"Obtaining the CE Mark represents a key milestone towards continuing the global commercialization of our differentiated robotic technology and our commitment to improving patients' lives and partnering with surgeons to transform orthopedic surgery."
According to the company, “TSolution One is a robotic system that enables surgeons to create the patient's personalized pre-surgical joint replacement plan, using CT-based 3D planning and the system's open implant library to achieve an optimized surgical plan.”
“During surgery, the robot precisely executes the patient's individual surgical plan by removing diseased bone and preparing the bone cavity and joint surface with sub-millimeter dimensional accuracy.”
John Hahn told OTW, “The timing of receiving the CE mark for the TSolution One TKA application this year is an important milestone for THINK Surgical for multiple reasons.”
“First, it allows us to bring our active robotic platform to the European market. Second, the CE mark also opens the door to regulatory approval in several other countries which allows THINK to expand the use of TSolution One worldwide.”
“This comes in the midst of us working to complete enrollment in our multi-center IDE [investigational device exemption] clinical trial for the TKA application as part of our U.S. commercialization strategy next year. The regulatory process is dynamic at THINK as we have regulatory submissions in progress in multiple regions. Attention to thorough and timely regulatory submissions and responses has enabled a smooth process overall.”
Asked about their plans for European expansion, Hahn commented to OTW, “We are establishing a distributor network for major countries in EU [European Union], to reach the market sooner. Among them are UK, France, Italy, and Spain.”
“Surgeon training is very important to THINK Surgical in our expansion and we plan to work with a few orthopaedic surgeons early-on to develop a strong training curriculum.”
“Research is also in our plans and we currently are collaborating in Switzerland with a prominent medical institution, Centre Hospitalier Universitaire Vaudois, through its Swiss BioMotion Laboratory, for research using our active robotic system.”
“This site can serve strategic purposes during our commercialization process. CE Mark Approval will expedite opening doors in many other countries and where we are additionally forming strategic partnerships. Currently we are working with an implant company to become a distributor of our system in Asia Pacific.”