Navigation Links
First FLEXUS(TM) Interspinous Spacer Surgeries for IDE Clinical Trial
Date:8/15/2008

AUDUBON, Pa., Aug. 15 /PRNewswire/ -- Globus Medical, Inc., the largest privately held spinal implant manufacturer in the world, today announced that the first FLEXUS(TM) Interspinous Spacers have been implanted under an Investigational Device Exemption ("IDE") recently granted to Globus by Dr. Donald Johnson II and Dr. Rhett Murray.

The FLEXUS(TM) Spacer is placed with a unilateral approach between two spinous processes with minimal disruption to the surrounding musculature and tissue. FLEXUS(TM) is a unitary radiolucent implant that requires no intra-operative assembly and a single incision to insert. It is manufactured from PEEK radiolucent polymer rather than titanium to more closely match the biomechanical properties of bone and eliminate MRI scatter.

"FLEXUS(TM) is the culmination of utilizing surgeon input and engineering simplicity to create innovative technologies to treat spinal stenosis. The FLEXUS(TM) IDE reflects Globus' position as the worldwide leader in the development of posterior motion preservation devices. We are excited to begin the clinical trial to develop strong supportive data for the product," said Michael Boyer, Group Engineering Manager for Interlaminar Fixation.

"The combination of a unilateral approach and a unitary implant makes FLEXUS(TM) not only a more efficient procedure but also one that is less traumatic to the patient," said Dr. Donald Johnson II, a spine surgeon of the Southeastern Spine Institute in Mt. Pleasant, S.C. "I am pleased with the PEEK design as it will enable better radiographic follow-up and allow me to monitor both the decompression and the adjacent anatomy."

After implanting the first FLEXUS(TM) device, Dr. Rhett Murray, a neurosurgeon of The Spine and Neurosurgery Center in Huntsville, Ala., said, "The surgical technique and approach was very straightforward. The simplicity of the FLEXUS(TM) design in distracting the stenotic segment may be beneficial in treating this painful condition. We are excited to participate in this IDE."

The 340 patient prospective, randomized FLEXUS(TM) IDE study will seek to prove equivalence with the X-Stop device over the two year study period. The study will involve patients that are over 50 years old who may benefit from the decompression provided by the FLEXUS(TM) device, at up to 20 clinical sites across the United States.

About Globus Medical, Inc.

Globus Medical, Inc. is the largest privately held spinal implant manufacturer in the world. Based in Audubon, Pa., the privately held company was founded in 2003 by an experienced team of spine professionals with a shared vision to create products that enable spine surgeons to employ both fusion and non-fusion solutions to promote healing in patients with spinal disorders. Globus Medical has a full portfolio of spinal fusion products, burgeoning initiatives in biomaterials development and minimally invasive approaches, and is among the world leaders in the development of motion sparing technology. Additional information can be accessed at http://www.globusmedical.com.


'/>"/>
SOURCE Globus Medical, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Cell Therapeutics Announces that the European Organization for Research and Treatment of Cancer Completes Enrollment in Phase II Clinical Trial of Brostallicin as First Line Therapy for Advanced or Metastatic Soft Tissue Sarcoma
2. Peregrine Pharmaceuticals Doses First Patient in Phase II Trial of Bavituximab in Patients With Advanced Breast Cancer
3. Alexion Secures U.S. Patent for ALXN6000, a First-In-Class Anti-CD200 Monoclonal Antibody
4. First DuraHeart(TM) Left Ventricular Assist System Implanted in the U.S. Pivotal Trial
5. First U.S. Patient to Receive New Heart-Assist Device Doing Well After Surgery at University of Michigan
6. MicroDose Technologies Announces Achievement of Phase I Clinical Milestone Triggering First Milestone Payment Under Collaboration with Merck & Co., Inc.
7. First Molecular Tem-PCR Test to Identify Multiple Forms of Staph and MRSA Obtains CLIA Certificate
8. Sanofi Pasteur Shipping First Doses of Influenza Vaccine for the 2008-2009 Season in the US
9. First Ever Study on Alzheimers Disease Treatment in Hispanics Presented at Major Medical Meeting
10. Seattles Swedish Cancer Institute First in U.S. to Treat Cancer Patient with Elekta VMAT
11. Quark Pharmaceuticals Announces First Patient Dosing by Pfizer in Phase II Trial of RNAi Therapy in Diabetic Macular Edema
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/27/2017)... STOCKHOLM , Feb 27, 2017 Period October – ... Operating result amounted to SEK -16.4 (-6.4) million ... -0.27 per share (-0.22) before and after dilution Cash flow ... ... amounted to SEK 0.4 (0.4) million Operating result amounted to ...
(Date:2/24/2017)... -- Research and Markets has announced the addition of ... Forecast to 2025" report to their offering. ... The Global Wireless Health Market ... the next decade to reach approximately $330.5 billion by 2025. ... all the given segments on global as well as regional levels ...
(Date:2/24/2017)... and Markets has announced the addition of the "Dry eye Drugs ... ... Drugs Price Analysis and Strategies - 2016, provides drug pricing data and ... following questions: What are the key drugs ... in the Global Dry eye market? What are the ...
Breaking Medicine Technology:
(Date:2/26/2017)... KS (PRWEB) , ... February ... ... StaffBridge sets a new technology standard in staffing, scheduling, and reporting for ... monitor, and predict activity throughout the entire staffing process. StaffBridge technology improves ...
(Date:2/26/2017)... , ... February 26, 2017 , ... ... after receiving cognitive rehabilitation, according to a study released today at the 1st ... cognitive rehabilitation programs are proven to be effective in improving cognitive function in ...
(Date:2/25/2017)... ... February 25, 2017 , ... FCPX users now have the ability ... Film Studios. With ProSharpen Color users have total control over sharpening amount, sharpening radius, ... range. With color spectrum tools users can visually see the color range effected with ...
(Date:2/24/2017)... ... February 24, 2017 , ... Houston ... options at his office, Antoine Dental Center. Currently, patients can get single dental ... may apply, but patients can learn more about these offers by contacting Antoine ...
(Date:2/24/2017)... , ... February 24, 2017 , ... ... business development, education, networking and recognition opportunities as well as advocacy for the ... in Holmdel, NJ on February 23. The Council's Innovation Forecast event highlights ...
Breaking Medicine News(10 mins):