Could Data Backing Implant Shift Treatment?

A study demonstrated that after two years the minimally invasive iFuse procedure was more effective than conservative management.

Image courtesy of SI-BONE

Study data show that use of the iFuse Implant System (iFuse) for chronic low back pain attributed to the sacroiliac joint was safe and more effective than conservative management. The iFuse procedure is minimally invasive, requiring only a small incision along the side of the buttock, Jeffrey Dunn, CEO of SI-BONE, told MD+DI, adding that the procedure entails significantly less recovery time than open surgery for SI joint fusion (SIJF).

Dunn said that iFuse was designed to provide immediate stability, an important feature in treating SI joint dysfunction. “Our engineers designed the iFuse Implant as a small, triangular implant to minimize rotation of the joint as soon as it is implanted,” he said. “The implant has a porous surface to closely mimic the trabecular structure of cancellous bone supporting bone growth and long-term fusion.”

Published this month, “Randomized Trial of Sacroiliac Joint Arthrodesis Compared with Conservative Management for Chronic Low Back Pain Attributed to the Sacroiliac Joint” showed that minimally invasive SIJF with iFuse Implants was safe and more effective than conservative management in relieving pain, reducing disability, and improving patient function and quality of life at two years, Dunn said. “The study further demonstrates that the SI joint can be a source of chronic lower back pain and supports iFuse as an effective minimally invasive procedure for patients with SI joint pain,” he explained. “The study represents a significant clinical milestone for us because the results were published in the Journal of Bone and Joint Surgery (JBJS), one of the most prestigious general orthopedic journals. This publication signals the broad acceptance of SI joint surgery as an important topic of study in orthopedics. 

“Our company has invested heavily in clinical data establishing the safety, efficacy, quality of life and health economic benefits of iFuse,” Dunn continued. “No other SI joint fusion device or procedure on the market is supported by this level of clinical evidence, including 67 peer reviewed journal publications and level 1 data from three prospective multi-center trials supporting the efficacy of the procedure.”

Such data could have an impact. “Many physicians have not focused on the SI joint as a source for chronic lower back pain and as a result, misdiagnoses are common,” he said. “This study, our extensive clinical data, and the increasing number of iFuse procedures performed annually demonstrate that there is a shift in how physicians understand SI joint dysfunction and its role in causing chronic pain.”

Dunn reported that more than 37,000 iFuse procedures have been performed by more 1800 surgeons in the United States and 33 other countries around the world. “There is a significant, addressable, and growing market opportunity for iFuse: we believe there are 279,000 eligible patients each year in the United States alone, translating to a $2.7 billion market opportunity. SI-BONE also has strong and often exclusive reimbursement coverage, which is a significant contributor to our growth. This includes positive coverage decisions from 45 of the 65 largest private payers as well as 26 commercial coverage policies (~46M covered lives) exclusive to iFuse. We expect this trend to continue since no other competitive company has the clinical data to support equivalent claims.”

SI-BONE completed its IPO in October 2018 and plans to use the proceeds to fuel growth. “We plan to use this recent capital infusion to aggressively invest in growth over the next 5 – 10 years, by expanding sales and marketing efforts, educating and training thousands of new surgeons, and investing in other product development and other market expansion opportunities,” Dunn said.

The company recently partnered with PrinterPrezz to leverage its facilities and equipment for rapid prototyping of future implants, Dunn said, adding that the “arrangement will not change or impact the manufacture of our iFuse Implant System.”

Daphne Allen

Daphne Allen is editor-in-chief of MD+DI. She previously served as executive editor of Pharmaceutical & Medical Packaging News, which serves as the pharmaceutical and medical device channel of Packaging Digest. Daphne has covered medical device manufacturing, packaging, labeling, and regulatory issues as well as pharmaceutical packaging and labeling for more than 20 years. She is also a member of the Institute of Packaging Professionals's Medical Device Packaging Technical Committee. Follow her on Twitter at @daphneallen.

 

Filed Under
500 characters remaining