SI-BONE, Inc. (Cupertino, California), a medical device company that is pioneering the use of a minimally invasive surgical (MIS) device to treat the sacroiliac (SI) joint today announced that iFuse initial post-market clinical experience will be presented at upcoming 2010 minimally invasive spine surgery meetings.
SI-BONE has been working with several well-known spine surgeons with experience in low back pathologies, who are early adopters of new MIS technologies. These surgeons, including Steven Garfin, J. John Halki, Arnold Graham-Smith, Fred Geisler, Leonard Rudolf, David Polly, Michael Amaral and A. Nick Shamie, have been providing the Company clinical direction and feedback. Separately, these surgeons are working on the submission of manuscripts and abstracts to spine society meetings and peer-reviewed journals. Recently, Dr. Garfin presented details regarding SI joint disease, diagnosis and MIS treatment at the Mayo Spine Symposium in Hawaii and the Israeli Spine Society in April. Upcoming iFuse presentations include the World Congress of Minimally Invasive Spine Surgery & Technologies (WCMISST) in Las Vegas May 31-June 4, 2010, the North American Spine Surgery (NASS) in Orlando on October 7, 2010 and World Congress of Low Back & Pelvic Pain in Los Angeles November 9-12, 2010.
"We're very pleased to have such a high interest from our colleagues in undertaking clinical evaluation and presentation of post-market clinical experience regarding SI joint pathology and the iFuse MIS procedure as a new option for patients," said Dr. Garfin. He added, "I'm sure that these presentations will be instrumental in helping to increase awareness on diagnosis of SI joint problems, the treatment of patients non-operatively and with iFuse for those who have failed non-operative therapies."
According to Mark Reiley, MD, founder and Chief Medical Officer at SI-BONE, the iFuse post-market clinical experience appears to be very encouraging. Dr. Reiley reported, "In the recently accepted submissions, the investigators report on more than 50 patients treated with iFuse. Sacroiliac joint syndromes are common and the accepted submissions reinforce the need for awareness that the SI joint can produce symptoms."
Dr. Reiley further commented, "We are honored that our colleagues have agreed to bring their extensive clinical experience and patient-centric focus to our scientific efforts and dedication to ongoing improvements in our technology. We expect to benefit from their insights and expertise in understanding MIS SI Joint fusion as a frontline therapy for patients with unresolved low back symptoms refractory to conservative therapy. We will continue to reach out to other spine surgeons and referring specialists to encourage clinical evaluation of iFuse, and we look forward to their further contributions."
J. J. Halki, MD, principal investigator from Northern Nevada Medical Center in Reno, commented that, "physiatrists need to have an outlet for these previously, unsatisfied SI joint patients. In some patients with residual symptoms after hip arthroplasty or lumbar spine procedures, it may be the SI joint that is the symptom generator. With the advent of the iFuse MIS procedure, the surgeon may now be able to successfully treat patients refractory to conservative therapy and effectively partner with non-operative pain specialists to offer patients new treatment solutions."
In response to increasing awareness of SI Joint dysfunction as a debilitating symptom generator, SI-BONE, Inc. developed an innovative, patented, intramedullary implant to treat the SI Joint. The company is also planning a post-market multicenter study to determine its effect over time on SI Joint pathology and on symptoms associated with SI Joint dysfunction.
The iFuse Implant System is a commercially available device in the US intended for fracture fixation of large bones and large bone fragments of the pelvis for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. The iFuse procedure uses a minimal incision for delivery and implantation of small, titanium implants. The implants are coated with a porous plasma spray that acts as an interference surface, designed to help decrease implant motion. These implants have substantial thickness and sophisticated metallurgy and are able to produce a much stronger construct than that of conventional pins or screws used to surgically fix boney structures. This implant technology from SI-BONE has been previously used successfully in well over 1,000 cases of dysfunctional foot joints.
SOURCE SI-BONE, Inc.