ConforMIS, Inc. Receives CE Mark Certification for Minimally Invasive Patient-Specific Implants and Instrumentation
iUni™ and iJig™ Approved in All European Union Markets
BURLINGTON, Mass.--(BUSINESS WIRE)--ConforMIS, Inc., a privately held company that develops and commercializes minimally invasive medical devices for the treatment of osteoarthritis and joint damage, announced today it received CE Mark approvals for both the iUni™ uni-compartmental resurfacing device and the iJig™ instrument system for use with the iUni on December 3, 2007. The two products were CE Mark approved separately, with both providing regulatory approval for ConforMIS to begin sales of these products throughout the European Union and potentially provide the basis for approval or registration in other countries outside the U.S., including Australia and Canada.
“The CE Mark also opens the door to approvals in many other countries giving ConforMIS a clear path for significant geographic expansion.”
The iUni is a uni-compartmental resurfacing implant for the knee designed for patients whose arthritic damage is isolated to one of the tibiofemoral compartments of the knee, with little to no damage present in the other compartments. As with all ConforMIS implants, each iUni is designed off an individual patient’s CT scan using the company’s proprietary iFit™ technology and made specifically for that patient. The implant is available for the medial or lateral compartments.
The surgical procedure utilizes patient-specific instrumentation called iJigs that are designed off the same imaging data as the implant. The iJig cutting and placement guides significantly reduce the number of instruments required for the surgery, simplify the steps involved, and increase the reproducibility of surgical results.
“The CE Mark approvals for the iUni and iJig instrumentation represent ConforMIS’ entry into the European resurfacing market and is a significant move toward becoming a global provider of orthopedic implants,” said Michael Sharp, Senior Vice President of Regulatory and Clinical Affairs for ConforMIS. “The CE Mark also opens the door to approvals in many other countries giving ConforMIS a clear path for significant geographic expansion.”
“We are very pleased to be bringing the clinical advantages of patient-specific, bone preserving resurfacing implants to the European market. The early interest and positive reaction among surgeons to our novel implant designs and highly simplified surgical technique has been very gratifying,” added Jong Lee, SVP of Marketing.
Immediately following the iUni and iJig approvals, eight surgeries using both products were performed in Germany. “The first patient to receive an iUni in Europe was a 35 year old female. The individualized implants and instruments were less invasive in terms of incision length and bone resection, and allowed for simpler ligament balancing than other implants I’ve used. We are extremely pleased with the post-operative result as the patient has recovered quickly and remarkably well,” said Dr. Thomas Boehme, Orthopaedische Uniklinik Frankfurt Friedrichsheim, Germany.
“The precise fit of the iUni™ femoral and tibial components and individualized parts should benefit the patient in the long term,” said Dr. Alexx Ripp, chief surgeon of traumatology and orthopaedics at lblandklinik Radebeul in Radebeul, Germany.
In the spring of 2007, orthopedic implants such as those developed and manufactured by ConforMIS were moved from class two to class three for CE Mark approval, meaning the products underwent the most rigorous examination before being approved. The company has also had CE Mark approval for its iForma™ implant since 2006.
About ConforMIS, Inc.
ConforMIS, Inc. is a privately held company incorporated in 2004 that develops and commercializes medical devices for the treatment of osteoarthritis and joint damages. The Company’s novel and scaleable 'image-to-implant' process is comprised of two related technology platforms. iFit™ Technology enables the creation of conforming, patient-specific implants that are precisely sized and shaped to match the 3D topography of the patient's anatomic bone surfaces. The iJig™ Instrumentation enables the creation of novel disposable instrumentation that radically simplifies and improves the surgical process.
Both platforms are supported by proprietary, intellectual property consisting of more than 100 issued, allowed and pending patents or patent applications that span imaging software, image processing, implant design, surgical techniques and instrumentation.
To date, ConforMIS has developed a comprehensive line of minimally traumatic, bone and cartilage-preserving knee implants and instrumentation designed to address all stages of osteoarthritis, the most common reason for knee replacement surgery.