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 for
'/>"/>

SOURCE SI-BONE, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

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:12/19/2014)... , December 18, 2014 ... software application/module that is used to store, manipulate, ... RIS comprises a patient tracking and scheduling system, ... integration of RIS with HIS and other databases ... patient registration and patient scheduling, patient list management, ...
(Date:12/19/2014)... Calif. , Dec. 18, 2014  Sage ... new generation of equipment for the testing of ... release of the new Luminary™ Profiler, the industry,s ... light-based measurement in a cost-effective, portable unit. ... the specific needs of the cannabis industry, the ...
(Date:12/19/2014)... -- RESMED INC. (NYSE: RMD ) today announced that ... results on Thursday, January 22, 2015, after the New York ... will be issued after 1:00 p.m. US Pacific Time and ... and future outlook. The earnings call is scheduled ... live webcast of the call can be accessed on ResMed,s ...
Breaking Medicine Technology:The Global Radiology Information Systems Market is Expected to Grow at a CAGR of 7.5% from 2014 to 2019 2The Global Radiology Information Systems Market is Expected to Grow at a CAGR of 7.5% from 2014 to 2019 3Sage Analytics Develops Breakthrough System for Potency Testing of Cannabis Products 2ResMed To Announce Second Quarter 2015 Results 2
... 21, 2011 Within the last two years the Lap ... weight loss procedure for obese individuals. As a result, the ... increased as well, with the caliber of skill sometimes varying ... Angeles, a bariatric surgeon named Dr. Michael Feiz has taken ...
... Systems Inc. , a leading cardiac biomarker distributor in China, ... an official letter it received from the China State Food ... the SFDA confirmed that it has investigated Inverness Medical Beijing ... ), and suspects IMB of submitting of a forged copy ...
Cached Medicine Technology:VIP Care for Lap Band Patients Leads to Life Changing Results 2Chinmax Disclaims Liability Following China SFDA's Confirmation that Inverness Medical Beijing is Suspected of Forging SFDA Verification Seal and Approval Date in Submission of Triage BNP Test Registration 2
(Date:12/22/2014)... Florida (PRWEB) December 22, 2014 Give ... holiday season, the gift of health and vitality. , ... offering its three top-selling anti-aging formulas in special Holiday ... free rush delivery. , Each bottle contains cutting-edge, ... areas that don't work as well as we age. ...
(Date:12/22/2014)... 7,178 small business owners and marketing professionals ... and opted instead to join Digital Marketer, an Austin, ... 5th annual “Black Friday Boot Camp”. , ... the 5 hour online training event and raised $50,000 ... two Central Texas based charities dedicated to fighting childhood ...
(Date:12/22/2014)... (PRWEB) December 22, 2014 NAPW ... 2014 Professional Woman of the Year. She is recognized ... the largest, most recognized networking organization of professional women ... the National Association of Professional Women is a vibrant ... Local Chapters. , Ms. Kreider is passionate and committed ...
(Date:12/21/2014)... In this report, the global powered ... product, and application. The market, by power source, ... By product, the market covers the handpieces; power ... market is further subdivided into drills, saws, reamers, ... shavers, wire/pin drivers, and others. Moreover, the power ...
(Date:12/21/2014)... 2014 When families in Coral Gables get ... call? The new answer is Lice Troopers . Located ... their newest treatment center will be the new go-to resource ... without the use of harmful chemicals or pesticides. ... 1, 2015. Like the company’s first clinic (located at 1005 ...
Breaking Medicine News(10 mins):Health News:You Still Have Time to Give the Gift of Health and Vitality to a Mature Loved One 2Health News:Austin Company Digital Marketer Raises 100K to Fight Childhood Cancer 2Health News:Austin Company Digital Marketer Raises 100K to Fight Childhood Cancer 3Health News:National Association of Professional Women Announces Cheryl A. Kreider, President / CEO of Kreider Health Solutions, LLC, a 2014 Professional Woman of the Year 2Health News:Global Powered Surgical Instruments Market Hit to $2.1 billion by 2019 - New Research Report by MarketsandMarkets 2Health News:Global Powered Surgical Instruments Market Hit to $2.1 billion by 2019 - New Research Report by MarketsandMarkets 3Health News:Global Powered Surgical Instruments Market Hit to $2.1 billion by 2019 - New Research Report by MarketsandMarkets 4Health News:All-Natural Florida Lice Removal Company Opens New Lice Treatment Salon In South Florida 2
... Institute researcher Jeff Tyner, Ph.D., has created a way to ... myeloid leukemia using an assay that yields results in just ... Society of Hematology annual meeting in Atlanta, on Monday, Dec. ... assay, called RAPID, because it rapidly delivers the information, has ...
... DIEGO, Dec. 10 ADVENTRX Pharmaceuticals,Inc. (Amex: ... on commercializing proprietary product candidates for the treatment,of ... M. Culley,ADVENTRX,s chief business officer, is scheduled to ... as part of a panel on Better Drugs ...
... Human Resources Professional Brings Diverse Expertise, MIAMI, ... biotherapeutic products to healthcare providers, is pleased,to announce ... Vice President of,Human Resources. Ms. Lopez was most ... & Johnson Company. Her 17-year career began,in Human ...
... States may be less likely to report a family history ... prevention strategies according to a new study. Dr. Heather Orom ... colleagues argue that as a result of being less likely ... as strong a predictor of cancer risk in immigrant populations. ...
... and post-stem cell transplantation results compared to thalidomide and ... ... Pharmaceuticals,Inc. (Nasdaq: MLNM ) reported the presentation of results from ... randomized,Phase III clinical trial. This study compared VELCADE, thalidomide and,dexamethasone (VcTD) ...
... improvement across all ... survival -, ATLANTA, Dec. 9 Millennium Pharmaceuticals,Inc. ... results from the,682 patient, randomized, Phase III VISTA(1) trial. ... for stem cell,transplantation (SCT). The trial compared VELCADE, melphalan ...
Cached Medicine News:Health News:OHSU Cancer Institute researcher develops test for targeted therapy in acute myeloid leukemia 2Health News:ADVENTRX Pharmaceuticals to Present at the 2007 RBC Capital Markets Healthcare Conference 2Health News:Novis Pharmaceuticals Hires Lisa Lopez 2Health News:Immigrant patients less likely to report family history of cancer 2Health News:Phase III Trial of VELCADE(R) (Bortezomib) for Injection Showed Dramatic Fourfold Increase in Complete Remission Rates When Combined With the Most Commonly Used U.S. Regimen in Front-Line Multiple Myeloma 2Health News:Phase III Trial of VELCADE(R) (Bortezomib) for Injection Showed Dramatic Fourfold Increase in Complete Remission Rates When Combined With the Most Commonly Used U.S. Regimen in Front-Line Multiple Myeloma 3Health News:Phase III Trial of VELCADE(R) (Bortezomib) for Injection Showed Dramatic Fourfold Increase in Complete Remission Rates When Combined With the Most Commonly Used U.S. Regimen in Front-Line Multiple Myeloma 4Health News:Phase III Trial of VELCADE(R) (Bortezomib) for Injection Showed Dramatic Fourfold Increase in Complete Remission Rates When Combined With the Most Commonly Used U.S. Regimen in Front-Line Multiple Myeloma 5Health News:Phase III Trial of VELCADE(R) (Bortezomib) for Injection Showed Dramatic Fourfold Increase in Complete Remission Rates When Combined With the Most Commonly Used U.S. Regimen in Front-Line Multiple Myeloma 6Health News:Highest Reported Complete Remission Rate of 35 Percent Achieved in a Phase III Front-Line Multiple Myeloma Trial With Velcade(R) (Bortezomib) for Injection Based Therapy 2Health News:Highest Reported Complete Remission Rate of 35 Percent Achieved in a Phase III Front-Line Multiple Myeloma Trial With Velcade(R) (Bortezomib) for Injection Based Therapy 3Health News:Highest Reported Complete Remission Rate of 35 Percent Achieved in a Phase III Front-Line Multiple Myeloma Trial With Velcade(R) (Bortezomib) for Injection Based Therapy 4Health News:Highest Reported Complete Remission Rate of 35 Percent Achieved in a Phase III Front-Line Multiple Myeloma Trial With Velcade(R) (Bortezomib) for Injection Based Therapy 5Health News:Highest Reported Complete Remission Rate of 35 Percent Achieved in a Phase III Front-Line Multiple Myeloma Trial With Velcade(R) (Bortezomib) for Injection Based Therapy 6Health News:Highest Reported Complete Remission Rate of 35 Percent Achieved in a Phase III Front-Line Multiple Myeloma Trial With Velcade(R) (Bortezomib) for Injection Based Therapy 7
... very high frequency digital ultrasound eye arc-scanner. ... microscopic resolution images and precision measurement capabilities ... the human eye. Artemis is a very ... use, the patient leans forward placing their ...
... OTI-Scan 1000 is the most advanced ophthalmic ... system operates with a single Macintosh desktop ... with a streamlined internal probe rotator. Every ... designed. The UltraFast 12 MHz B-probe operates ...
... The AB5500 is a combination A-scan and ... capabilities. The A-scan incorporates a high frequency, ... which enables scan capture immediately upon application ... In cases where the axial length of ...
The ultimate ultrasound system for clinical ophthalmologists....
Medicine Products: