SAN JOSE, Calif., Sept. 14 /PRNewswire/ -- SI-BONE, Inc. (San Jose, California), a medical device company that is pioneering the use of a minimally invasive surgical (MIS) device to treat the sacroiliac (SI) joint announced today that it is launching training for its iFuse Implant System™ and anticipates CE Mark at anytime. A CE Mark is the certification requirement recognized by members of the European Union for sales and distribution into those countries. The company has recently received ISO 13485 Certification, which demonstrates that it provides medical devices and related services that consistently meet customer and regulatory requirements. The company plans to introduce the iFuse Implant System in the EU at the upcoming Eurospine Meeting in Vienna, September 14-17, where it will be exhibiting in booth 68.
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 provide 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.
European surgeon training sessions are scheduled for October and November in Salzburg, Austria. These sessions will be presented by surgeon faculty who have performed dozens of iFuse surgeries in the United States and be coordinated by Vanes Frison, the company's European Training and Product Manager.
Commenting on the anticipated CE Mark and EU launch, Jeff Dunn, President and CEO, said,
|SOURCE SI-BONE, Inc.|
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