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 implant motion.
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 labs.
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 conditions."
"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.