SI-Bone is focused on advancing the diagnosis and treatment options for patients with sacroiliac (SI) joint pain by using the minimally invasive iFuse Implant System. Over the last few years more than 13,000 procedures have been performed and more than 850 surgeons have been trained to provide this treatment for their patients.
The European caught up with Andrea Mercanti, Vice President EMEA Operations, SI-BONE, to find out about the procedure and research underpinning its effectiveness.
Q: What additional improvements does the iFuse Implant System offer compared with traditional sacroiliac surgical procedures?
Andrea Mercanti: At SI-Bone we understand the importance of evidence-based medicine. Recent results published from two clinical trials demonstrate the additional improvements the iFuse system offers. The first of these publications, entitled Open vs. minimally invasive sacroiliac joint fusion: a multi-center comparison of perioperative measures and clinical outcomes, is a retrospective comparative cohort study that compares the safety and effectiveness of MIS SI joint surgery using the iFuse Implant System to open SI joint fusion. It is the largest study of its kind and presents the largest published cohort of both groups (MIS and open surgery).
The study concluded that the complication rate was lower in the minimally invasive group (iFuse) when compared to the open surgery group, with fewer patients undergoing revision of their prostheses (3.5 per cent vs. 44 per cent respectively). Patients who underwent the MIS SI joint fusion procedure experienced significantly greater pain relief and more favourable perioperative surgical measures when compared to the open surgery group.
The second publication, entitled Safety and 6-month effectiveness of minimally invasive sacroiliac join fusion: a prospective study, reports early results from the SIFI (Sacroiliac Joint Fusion with iFuse Implant System) study, a multicentre, single-arm, prospective clinical trial. This landmark study is the first prospective multicentre study designed to evaluate the effectiveness of a minimally invasive SI joint fusion technique in patients with degenerative sacroiliitis or SI joint disruption. The study reported no device revisions or removals.
The benefits seen when using the iFuse system include: minimised rotation of the implant and immediate stabilisation of the SI joint due to the implants triangular profile. Its porous titanium plasma spray (TPS) coating allows for biological fixation (a technology used for decades in other medical applications, such as orthopaedics and dentistry) and when compared to 8.0 mm screws, the iFuse is three times stronger under shear and bending loads. With more than 13,000 procedures performed globally, more than five years follow up and over 15 published studies, in peer-reviewed journals demonstrating safety and clinical results, iFuse is the method of choice for SI joint fusion worldwide today.
Q: What are the indications for the iFuse implant system in treating SI Joint pain?
AM: The iFuse system was granted FDA approval in 2008 and thereafter, its CE mark in 2010, for the treatment of conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruptions and degenerative sacroiliitis.
Like any other joint in the body, the sacroiliac (SI) joint can become arthritic or its support ligaments can become loose or injured. When this happens, people can feel pain in their buttock and sometimes above their buttock and higher on the skeleton. This is especially true with lifting, running, walking or sleeping on the involved side.
Bernard and Kirkaldy-Willis (Recognizing specific characteristics of nonspecific low back pain, Clinical Orthopedics, 1987) reported that over 22 per cent of individuals who presented with lower back complaints actually had problems in their sacroiliac joint.
Studies by Cohen et al (Sacroiliac Joint Pain: A Comprehensive Review of Anatomy, Diagnosis, and Treatments, Sacroiliac Anesth Analg 2005) show that up to 25 per cent of all lower back pain is sacroiliac joint in its origin and that the diagnosis of sacroiliac joint disease is frequently overlooked by physicians.
Further studies by Weksler, et al (The role of Sacroiliac Joint dysfunction in the genesis of low back pain: the obvious is not always right, 2007), reported that sacroiliac joint dysfunction mimics disco genic or radicular lower back pain. In fact, many lower back pain patients go on to receive lumbar fusion surgery instead of sacroiliac joint fusion. In light of this, sacroiliac joint disease must be strongly considered in the differential diagnosis of low back pain.
Q: Why should the sacroiliac joint be considered as a potential lower back pain generator?
AM: The SI joint has been recognised as a potential source of lower back pain and patients have been surgically treated for this dating back to the 1920s. Numerous publications have studied and reported on the prevalence of SI joint pain as a primary component of lower back pain as well as in patients with prior lumbar fusion. Published data suggests it is common for pain generated by the SI joint to mimic disc or low back pain. To avoid unnecessary lumbar spine surgery, SI joint disorders should be considered in lower back pain diagnosis. The right patient selection is crucial for the success of any therapy.
Q: SI-BONE have recently announced a European expansion with the formation of SI-BONE GmbH in addition to your current European headquarters in Italy. Will this strategy be adopted across other European markets?
AM: I joined SI-BONE in September 2010 as Vice President European Operations, and we performed the first case in December 2010, immediately after the CE mark approval. In 2011, we opened SI-BONE srl, our European headquarters in Gallarate near Milan.
Our new German entity has its headquarters in Mannheim, which further strengthens the company’s presence in Europe. Simultaneously we will continue to work across Europe to support our partners to grow SI-BONE through evidence based treatments.
Q: What strategies do you have in place for European revenue expansion?
AM: Since the CE mark approval in November 2010, we are currently present in 17 European countries, with a hybrid sales model.
We have today two direct branches, and our strategy is to keep focused on the market development with our local country partners outside Germany and Italy. In addition we are also currently focusing on expanding our business in the Middle East.
Q: Eric Schaber has been appointed as general manager in Germany. What will he bring to SI-BONE?
AM: Mr Schaber brings to SI-BONE more than 23 years of international sales and marketing experience in the medical device, trauma and orthopaedic spine markets. Most recently, he served as vice president of European Operations and Managing Director for DFINE, Inc. where in 2008 he started and led its European and international operations and grew the German operation to 43 people. Before joining DFINE, Mr Schaber held several sales management positions at Kyphon including vice president of international commercial operations.
Mr Schaber’s knowledge of the spine business, and his experience developing new markets and delivering cutting edge MIS technologies in Germany and Europe, is a significant addition to our team.
About Andrea Mercanti
Andrea Mercanti, Vice President EMEA Operations, SI-BONE, joined SI-BONE in September 2010 and in just four years, starting from zero, has introduced iFuse into 17 countries to date.
To find out more please visit: si-bone.com