SAN JOSE, Calif., Oct. 1, 2014 /PRNewswire/ — SI-BONE, Inc., a medical device company that pioneered the use of the iFuse Implant System,®a minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, today announced the expansion of its European operations with the formation of a GmbH and the appointment of Mr. Eric Schaber as General Manager, Germany. Mr. Schaber will join former Kyphon colleague Andrea Mercanti, currently vice president of Europe, Middle East and Asia Operations at SI-BONE to expand the sales organization in Germany. The new GmbH will be headquartered in Mannheim, Germany and will strengthen the company’s presence in Europe by adding a second European office in addition to SI-BONE’s current European headquarters in Gallarate, Italy. Mr. Schaber will lead the German strategy and build a significant German sales team to support SI-BONE’s customers.
“We are extremely excited to have Eric join our European team and I am looking forward to the opportunity to work with Eric again to grow our business in Germany. Eric’s knowledge of the spine business and his experience developing new markets and delivering cutting edge MIS technologies in Germany and Europe will be a significant addition to our team,” said Andrea Mercanti, vice president of Europe, Middle East and Africa at SI-BONE.
SI-BONE, Inc. received original 510(k) clearance in November 2008 from the Food and Drug Administration (FDA) to market its iFuse Implant System. The CE mark for European commercialization was obtained in November 2010.
Clinical publications have identified the SI joint as a pain generator in up to 15 – 30% of low back pain patients.1,2,3,4 In addition, the prevalence of SI joint pain in post-lumbar fusion, so called “failed back surgery” patients, has been shown to be 43% and may be higher.5 Initial treatment options for patients with SI joint disorders typically involve non-surgical management and, when non-surgical treatment of the SI joint fails, surgical treatments such as the iFuse procedure may provide an option.
The iFuse Implant System is a minimally invasive surgical option that uses titanium implants coated with a porous, titanium plasma spray (TPS) that acts as an interference surface, designed to help decrease implant motion and provide immediate fixation and allow for biological fixation to support long term fusion. The iFuse System is intended for sacroiliac joint fusion for conditions including SI joint dysfunction that is a direct result of SI joint disruptions and degenerative sacroiliitis. As with all surgical procedures and permanent implants, there are risks and considerations associated with surgery and use of the iFuse Implant.
About SI-BONE, Inc.
SI-BONE, Inc. (San Jose, California) is the leading sacroiliac joint medical device company dedicated to the development of tools and products for diagnosing and treating patients with low back issues related to SI joint disorders. The company has developed, and is manufacturing and marketing, less invasive approaches using implants for the treatment of certain SI joint pathology. SI-BONE has an experienced management team with extensive experience in orthopedic and spine medical devices. SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. ©2014 SI-BONE, Inc. All Rights Reserved. 8956.100114
1 Bernard TN, Kirkaldy-Willis WH. Recognizing Specific Characteristics of Nonspecific Low Back Pain. Clinical Orthopedics and Related Research. 1987;217:266–80.
2 Schwarzer AC, Aprill CN, Bogduk N. The Sacroiliac Joint in Chronic Low Back Pain. Spine. 1995;20:31–7.
3 Maigne JY, Aivaliklis A, Pfefer F. Results of Sacroiliac Joint Double Block and Value of Sacroiliac Pain Provocation Tests in 54 Patients with Low Back Pain. Spine. 1996;21:1889–92.
4 Sembrano JN, Polly DW. How Often is Low Back Pain Not Coming From The Back? Spine. 2009;34:E27–32.
5 DePalma M, Ketchum JM, Saullo TR. Etiology of Chronic Low Back Pain Patients Having Undergone Lumbar Fusion. Pain Medicine.2011;12:732-9.
SOURCE SI-BONE, Inc.