iFuse implant system receives CE Mark
23 Nov 2010
SI-BONE, Inc. a medical device company that is pioneering the
use of a minimally invasive surgical device to treat the sacroiliac (SI)
joint, has received a CE mark for its iFuse Implant System.
The company has also received ISO 13485 Certification, which
demonstrates that it provides medical devices and related services
that consistently meet customer and regulatory requirements.
The iFuse Implant System is a minimally invasive surgical (MIS)
system comprised of titanium implants coated with a porous plasma
spray that acts as an interference surface fit, which helps decrease
The iFuse has a substantial thickness and sophisticated
metallurgy, which provides immediate post-operative fixation,
accomplishing the goal of traditional open SI joint fusion through
an MIS approach. Clinical publications have identified the SI joint
as a pain generator for up to 22% of low back pain patients and that
up to 75% of post-lumbar fusion patients develop SI joint
degeneration within 5 years of surgery. These represent significant
unmet clinical needs and, when conservative therapy fails, iFuse may
provide an MIS option.
The first European surgeon training sessions were held in October
and most recently for November in Salzburg, Austria. These sessions
are presented by surgeon faculties who have performed dozens of
iFuse surgeries in the United States. The company's European
Training and Product Manager, Vanes Frison, is coordinating the
Commenting on the CE Mark and EU launch, Jeff Dunn, President and
CEO, said, "The iFuse Implant System provides spine surgeons with a
unique minimally invasive surgical approach to SI joint
fixation/fusion. The CE mark will allow our EU Team to develop a
presence in selected EU markets to address the needs of physicians
committed to treating patients with SI joint problems. SI-BONE looks
forward to entering these markets because we offer the only
technology which provides an MIS solution to treat these SI joint
"Our product provides a technologically advanced alternative to
the conventional open SI joint fusion as well as an option for
patients who have failed conservative therapy. The key to the iFuse
procedure is the device design and minimally invasive technique. We
insert the implants across the SI joint in a one hour procedure and
it gives us the stability that we need," said Mark Reiley, M.D.,
Chief Medical Officer and founder of SI-BONE.
The CE mark for this system follows the clearance the company
received in November 2008 from the US FDA to market its iFuse
Implant System. The iFuse is indicated for use in fracture fixation
of large bones and large bone fragments of the pelvis for conditions
including sacroiliac joint disruptions and degenerative sacroiliitis.
In addition to training and engaging key spine surgeons in the
EU, surgeons in the US presented their initial clinical data at NASS
in Orlando on October 7th. Additional retrospective data was also
presented at several significant meetings, including the American
Academy of Physical Medicine and Rehabilitation (AAPM&R) on November
5, the Society of Minimally Invasive Spine Surgery (SMISS) on
November 6 and World Congress of Low Back & Pelvic Pain in Los
Angeles on November 12.
In response to increasing awareness of SI joint disruption and
dysfunction as debilitating symptom generators, SI-BONE, Inc.
developed an innovative, patented, intramedullary implant to treat
the SI joint. The company is also embarking on a post-market
multicenter study to determine its effect over time on SI joint
pathology and on symptoms associated with SI joint problems.