Navigation Links
iFuse Implant System™ Launches at Eurospine

SAN JOSE, Calif., Sept. 14 /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 today that it is launching training for its iFuse Implant System™ and anticipates CE Mark at anytime. A CE Mark is the certification requirement recognized by members of the European Union for sales and distribution into those countries. The company has recently received ISO 13485 Certification, which demonstrates that it provides medical devices and related services that consistently meet customer and regulatory requirements. The company plans to introduce the iFuse Implant System in the EU at the upcoming Eurospine Meeting in Vienna, September 14-17, where it will be exhibiting in booth 68.

The iFuse Implant System is a minimally invasive surgical (MIS) system comprised of titanium implants coated with a porous plasma spray that acts as an interference surface fit, which helps decrease implant motion. The iFuse has a substantial thickness and sophisticated metallurgy, which provide 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 and, when conservative therapy fails, iFuse may provide an MIS option.

European surgeon training sessions are scheduled for October and November in Salzburg, Austria. These sessions will be presented by surgeon faculty who have performed dozens of iFuse surgeries in the United States and be coordinated by Vanes Frison, the company's European Training and Product Manager.

Commenting on the anticipated CE Mark and EU launch, Jeff Dunn, President and CEO, said, "The iFuse Implant System provides spine surgeons with a unique minimally invasive surgical approach to SI joint fixation/fusion. The CE mark will allow our EU Team to develop a presence in selected EU markets to address the needs of physicians committed to treating patients with SI joint problems. SI-BONE looks forward to entering these markets because we offer the only technology which provides an MIS solution to treat these SI joint conditions."

"Our product provides a technologically advanced alternative to the conventional open SI joint fusion as well as an option for patients who have failed conservative therapy. The key to the iFuse procedure is the device design and minimally invasive technique. We insert the implants across the SI joint in a one hour procedure and it gives us the stability that we need," said Mark Reiley, M.D., Chief Medical Officer, orthopedic surgeon, and founder of SI-BONE.

The European sales and distribution for this system, pursuant to receiving CE Mark certification, will follow the clearance the company received in November 2008 from the Food and Drug Administration (FDA) to market its iFuse Implant System. The iFuse is indicated for use in fracture fixation of large bones and large bone fragments of the pelvis for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

In addition to training and engaging key spine surgeons in the EU, surgeons in the US are preparing to report their initial clinical data at several significant spine meetings this fall, including North American Spine Surgery (NASS) in Orlando on October 7 on the main floor and at SI-BONE's Satellite Symposium on October 6, the American Academy of Physical Medicine and Rehabilitation (AAPM&R) on November 5, the Society of Minimally Invasive Spine Surgery (SMISS) on November 6 and World Congress of Low Back & Pelvic Pain in Los Angeles on November 12.

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 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.

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.

Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. iFuse Implant System(TM) to be Presented at Leading Minimally Invasive Spine Surgical Meetings
2. Osteotechs MagniFuse(TM) Distributed to 68 U.S. Hospitals as Product Revenue Surpasses $1 Million
3. Osteotech Highlights Three Procedure-Specific MagniFuse(TM) Bone Grafting Products at the NASS 2009 Annual Meeting
4. Osteotechs MagniFuse(TM) Technology Used in First U.S. Surgery
5. Reportlinker Adds ENT Devices Market Outlook in Argentina to 2016 - Hearing Aid Devices and Implants and Diagnostic Devices
6. Reportlinker Adds Hip and Knee Implants - Global Pipeline Analysis, Opportunity Assessment and Market Forecasts to 2016
7. Ascension Orthopedics Implants First PyroCarbon Shoulder Device in United Kingdom
8. Salinas Valley Memorial Completes Successful Implant of Cardiac Monitor and Alert System
9. 100 Percent Coverage of Struts and Complete Neointimal Coverage of OrbusNeichs Genous™ Bio-engineered R stent™ Demonstrated 26 Days Post-Implantation in STEMI Patient
10. ICAP Ocean Tomo Offers for Sale IP Portfolio of Active Implants for Electromagnetic Bone and Tissue Regeneration in Orthopedics, Trauma, and Wound Care
11. Reportlinker Adds Opportunities in Non-Surgical Bio-Implants: Marketed injectable biomaterials, applications, and leading players
Post Your Comments:
(Date:12/1/2015)... BOSTON , December 1, 2015 Russia ... phase III clinical trials. 70% of new drugs registered in ... trials in Russia . --> Russia has ... trials. 70% of new drugs registered in Europe ... . --> Russia has always been ...
(Date:12/1/2015)... , Dec. 1, 2015 Relmada Therapeutics, Inc. ... treatment of chronic pain, announced today that the company will ... be held December 1-3 at the Luxe Sunset Boulevard Hotel ... Traversa , CEO of Relmada Therapeutics, will present on Thursday, ... Time). . Please register at least 10 ...
(Date:12/1/2015)...   MabVax Therapeutics Holdings, Inc . (OTCQB: MBVX), ... filed an Investigational New Drug Application (IND) with the ... lead fully human antibody product HuMab 5B1 as a ... initiate the Phase I clinical trial early in 2016. ... The planned Phase I trial will evaluate the safety, ...
Breaking Medicine Technology:
(Date:12/1/2015)... NY (PRWEB) , ... December 01, 2015 , ... ... non-traumatic limb amputations in the United States. Podiatrists are well aware that psychology-based ... adopt therapeutic behaviors) are often catastrophic contributors to diseases of the diabetic foot. ...
(Date:12/1/2015)... ... December 01, 2015 , ... For the ... is why Hollister Incorporated has launched the VaPro Plus Pocket™ touch free hydrophilic ... the VaPro touch free catheter portfolio,” said Michael Gresavage, Vice President North America. ...
(Date:12/1/2015)... ... December 01, 2015 , ... Next IT Healthcare, the leader ... in this year’s Fierce Innovation Awards: Healthcare Edition, an awards program from the ... finalist in the category of Digital Solutions for its innovative, industry-leading product, Alme ...
(Date:12/1/2015)... ... 2015 , ... TCS Healthcare Technologies (TCS), a leading provider ... is pleased to announce that VIP Care Services, a Caprock Health Group affiliate ... Complete Care™ Management to back their collaborative catastrophic case management initiatives. ACUITY Complete ...
(Date:12/1/2015)... GA (PRWEB) , ... December 01, 2015 , ... ... supports SACC-GA and SACC-USA through membership and leadership since 2008. Gary ... Chair for SACC-USA . Gary has spent a significant amount of time ...
Breaking Medicine News(10 mins):