Navigation Links
FDA Approves Updated, Clarified Indication for Use for iFuse Implant System®
Date:4/25/2011

SAN JOSE, Calif., April 25, 2011 /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 the U.S. Food and Drug Administration (FDA) approved a major modification to the existing product label. The Approval targets the use of iFuse Implant System® for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

In the spirit of collaboration, FDA-OSDB worked with SI-BONE, Inc. to arrive at a more accurate description of the intended use of the iFuse System. The communications were helpful in differentiating the iFuse System from fracture fixation devices. Based upon internal discussions, as well as a review of the medical literature related to SI joint disease and associated clinical care, FDA agreed to remove "fracture" from the indications for use and to further modify the indications for use statement as follows: "The SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis, as the Agency believed this is more in line with the true intent of SI Joint Fusion System."

Commenting on the FDA approval of SI-BONE's 510(K), CEO, Jeff Dunn said, "This approval from the Agency provides us with a significant advantage in getting the word out on appropriate diagnosis of low back complaints that include the SI joint and that an MIS option for patients with SI joint problems and provides us with a unique opportunity to teach spine surgeons about the iFuse Implant System for SI joint fixation/fusion."

Barbara Bunger, Vice President, Clinical, Regulatory and Quality at SI-BONE stated, "It's important for companies, like SI-BONE, Inc., to work closely with the FDA in developing solutions for patients with low back complaints due to the SI joint and the company looks forward to further collaborations and discussions with the Agency as the clinical development plan progresses. Our working relationship will ensure the design of a pivotal study that will provide clinical data to support low back pain claims."

SI-BONE received 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. The iFuse provides 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 where iFuse may provide an MIS option.

In response to increasing awareness of SI joint disruption and dysfunction as debilitating symptom generators, SI-BONE, Inc. developed an innovative, patented, intramedullary implant to treat the SI joint. The company is also embarking on a post-market multicenter study to determine its effect over time on SI joint pathology and on symptoms associated with SI joint problems.

The iFuse Implant System is a commercially available device in the US intended for treatment of 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.

About SI-BONE, Inc.

SI-BONE, Inc. (San Jose, California) is a leading spinal medical device company dedicated to the development of tools and products for diagnosing and treating patients with low back issues related to sacroiliac (SI) joint pathology. The company has developed, and is manufacturing and marketing, less invasive approaches using implants for the treatment of SI Joint pathology. SI-BONE has an experienced management team with extensive experience in orthopedic and spine medical devices.

For more information:

http://www.spine-health.com/education-centers/sacroiliac-joint-dysfunction/physicians


'/>"/>
SOURCE SI-BONE, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Approves Lillys Osteoporosis Drug EVISTA(R) (raloxifene HCl) to Reduce The Risk of Invasive Breast Cancer in Two Populations of Postmenopausal Women
2. Health Canada Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for HIV
3. FDA Approves Cymbalta(R) for Maintenance Treatment of Major Depressive Disorder
4. European Commission Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for Virologically Suppressed Adults With HIV-1 Infection
5. FDA Approves MiddleBrooks Amoxicillin PULSYS for Pharyngitis/Tonsillitis in Adolescents and Adults
6. FDA Approves XYZAL(R) (levocetirizine dihydrochloride) Oral Solution for the Relief of Seasonal and Year Round Allergies and Chronic Idiopathic Urticaria
7. UM Maryland Industrial Partnerships Program Approves 18 Collaborative Research Projects, Worth $4.4 Million, Between University Faculty, State Technology Companies
8. U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated With Bipolar I Disorder in Pediatric Patients (10 to 17 Years of Age)
9. U.S. Food and Drug Administration Approves ORENCIA(R) (abatacept) for the Treatment of Moderate-to-Severe Polyarticular Juvenile Idiopathic Arthritis (JIA) in Patients Six Years and Older
10. FDA Approves HIFU Clinical Trial for Recurrent Prostate Cancer
11. EPA Approves XDS-CALUX(R) as Alternate Dioxin Test Method 4435
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/8/2016)... Dec. 8, 2016  The global biosurgery market is ... the forecast period of 2016 to 2021. The market ... from USD 18.21 billion in 2016. The market is ... of sports related injuries and spinal problems, increasing clearance ... of effective blood loss management. In this ...
(Date:12/8/2016)... -- KEY FINDINGS North America ... in 2016 and is expected to continue in the ... large number of surgical procedures that are taking place ... the patient temperature management market.) Patient warming and cooling ... blood during surgeries, lowering the risks of neurological disorders ...
(Date:12/8/2016)... , Dec. 8, 2016  Eli Lilly and Company ... of its phase 3 EXPEDITION3 trial at the 9 ... As previously disclosed, solanezumab did not meet the primary ... solanezumab initiated in people with mild dementia due to ... submissions for solanezumab for the treatment of mild dementia ...
Breaking Medicine Technology:
(Date:12/8/2016)... (PRWEB) , ... December 08, 2016 , ... ... technologies and development solutions for drugs, biologics and consumer health products, today announced ... was set up in 2006 as a non-profit organization to unite pharmaceutical and ...
(Date:12/8/2016)... ... December 08, 2016 , ... ... Affordable Care Act. Dr. Botelho advocates for the mass media launching of story ... people ongoing opportunities to share their unfortunate experiences; such a movement can generate ...
(Date:12/8/2016)... ... December 08, 2016 , ... ... that serve communities in and around the greater Phoenix metropolitan region, is announcing ... Connection. , The mission of the Homeless Youth Connection is to promote community ...
(Date:12/7/2016)... OF PRUSSIA, PA (PRWEB) , ... December 07, 2016 , ... ... clinical trials with the announcement that it is one of the early adopters completing ... Privacy Shield Framework is designed to provide companies on both sides of the Atlantic ...
(Date:12/7/2016)... ... December 07, 2016 , ... ... wrinkles and deep lines by smoothing and tightening the skin of the face ... there to address facial aging with very little downtime, Silhouette Instalift is a ...
Breaking Medicine News(10 mins):