Navigation Links
Flexuspine Receives FDA Conditional Approval to Begin a Feasibility Study of Its FSU (Functional Spinal Unit) Total Spine Arthroplasty System in the United States
Date:4/22/2010

PITTSBURGH, April 22 /PRNewswire/ -- Flexuspine, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted conditional approval to begin the initial phase of the Investigational Device Exemption (IDE) for a feasibility study of its FSU device. This is the first approved clinical study for a Total Spine Arthroplasty system in the U.S.

(Photo:  http://www.newscom.com/cgi-bin/prnh/20100422/NE91456 )

Flexuspine's FSU Total Spinal Segment Replacement is designed to provide an alternative to fusion by reestablishing mobility in an affected segment of the lumbar spine. The device is composed of an interbody disc component (Core) and posterior dynamic resistance component (Dampener) and is designed as a system to restore the motion and natural kinematics of the affected spine segment.

The approval process included an extensive review of Flexuspine's research, design and biomechanical testing of the FSU device by the FDA, as well as an assessment of Dr. Louis Nel Jr.'s first-in-man clinical series performed in South Africa.  "This is a much needed next step in spinal arthroplasty.  The potential advantages of this technology could make it the first real 'total' level replacement," commented Dr. Nel.

"The FSU is not like the currently approved disc or facet replacement devices on the market today that only partially rebuild the motion segment.  The FSU has three separate parts working together, similar to healthy discs and facets, and is designed to achieve segmental reconstruction from a single posterior approach," declared Erik Wagner, Chief Technical Officer.

"We are extremely proud of reaching this milestone after completing the tremendous amount of work that went into the development of the FSU device.  We are moving into this next phase of our business to verify and validate the science and technology behind the product," stated Vincent Jannetty, President and CEO of Flexuspine.

"We also just recently received multiple 'notices of allowance of claims' from the U.S. Patent and Trademark Office.  We are very pleased that these claims cover both the system and key features of the product.  This recognition by the patent office of the novelty of the system along with the launch of the clinical study, create the solid business foundation we have been working towards," continued Jannetty.  

Flexuspine plans to begin patient enrollment in the U.S. feasibility study soon while continuing to establish similar clinical study sites in several countries outside the U.S.  The goal of these international studies was, and still is, to collect additional data that may be used in support of a U.S. Pivotal Clinical Trial.  

About Flexuspine

Flexuspine is a privately held spine company based in Pittsburgh, PA.  Flexuspine is dedicated to the sole focus of pioneering the field of total spine arthroplasty by developing the FSU device as an alternative to lumbar fusion. For more information on Flexuspine please visit www.flexuspine.com.  


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

Related medicine technology :

1. Reclast(R) Receives US FDA Approval as First and Only Once-Yearly Treatment for Women With Postmenopausal Osteoporosis
2. Indevus Receives Approvable Letter From FDA for VALSTAR(R) for Bladder Cancer Therapy
3. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
4. Abbott Receives Supplemental FDA Approval for its Best-in-Class in Sensitivity RealTime HIV-1 Viral Load Test
5. GlaxoSmithKline Receives New HHS Order for H5N1 Bulk Antigen. First North American Clinical Trials with GSKs Candidate Pre-pandemic Flu Vaccine to Start.
6. CryoCor Receives FDA Approval for Right Atrial Flutter
7. Ranbaxy Receives Approval to Manufacture and Market Hydrocodone Bitartrate and Acetaminophen Tablets USP
8. Dimericine(R) Receives FDA Fast Track Designation for Treatment Of Photosensitivity in XP Patients
9. Poniard Pharmaceuticals Receives FDA Fast Track Designation for Picoplatin for Treatment of Small Cell Lung Cancer
10. Kosan Receives Completed Special Protocol Assessment for TIME-1 Pivotal Phase 3 Trial of Tanespimycin in Multiple Myeloma
11. The Female Health Company Receives USAID DELIVER PROJECT Order for 5 Million Units
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/4/2016)... , Feb. 4, 2016  SciClone Pharmaceuticals, Inc. ... it has entered into a settlement agreement with ... fully resolving the SEC,s investigation into possible violations ... the terms of the settlement agreement, SciClone has ... including disgorgement, pre-judgment interest and a penalty.  This ...
(Date:2/4/2016)... Feb. 4, 2016 Global Immunology Market ... to drive long-term market growth Summary ... of chronic disorders that affect 5–7% of western ... of their symptoms and key patient demographics, they ... immune pathways and an inappropriate immune response. Generally, ...
(Date:2/4/2016)... DIEGO, Feb. 4, 2016  Aethlon Medical, Inc. ... affinity biofiltration devices to treat life-threatening diseases, today ... 2016 ended December 31, 2015. ... objectives set forth in our last quarterly call, ... reinforce our long-term objective to establish the Aethlon ...
Breaking Medicine Technology:
(Date:2/5/2016)... ... February 05, 2016 , ... Successful recruitment ... new clinical and scientific initiatives have all marked the last 12 months at ... and CEO of the nation’s oldest cancer center, Candace S. Johnson, PhD, outlined ...
(Date:2/5/2016)... York, New York (PRWEB) , ... February 05, 2016 , ... ... life? The answer may be at the tips of your toes. Foot massage, whether ... as well as pure comfort and relaxation. The American Board of Multiple Specialties ...
(Date:2/5/2016)... ... February 05, 2016 , ... US Sports Camps ... in Dover, NH to direct high-performance kids yoga training. ChildLight Yoga Studio is centrally ... one hour from Boston. , ChildLight Yoga Studio founder Lisa Flynn expresses her excitement, ...
(Date:2/5/2016)... ... February 05, 2016 , ... Give To Cure ... search for and donate to Give To Cure’s campaign that is crowdfunding clinical trials ... users make and share payments through a smart device. In 2015 alone, Venmo processed ...
(Date:2/5/2016)... (PRWEB) , ... February 05, 2016 , ... Dr. Justin ... announce their 2nd Annual No Cost Dental Day to individuals in need. The event ... purpose of this No Cost Dental Day is to provide dental care to community ...
Breaking Medicine News(10 mins):