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(TM) uni-compartmental resurfacing device
and the iJig(TM) 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 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(TM) 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(TM) 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(TM) 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(TM) 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(TM) 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.
