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:5/12/2017)... , May 12, 2017  The China and ... washing technology that consumes less water, energy and detergent, and features ... first product LaughingU, a shoebox-sized washing machine that washes and sanitizes ... ... Product, LaughingU, is compact, and does not require an external water ...
(Date:5/10/2017)... 10, 2017 Radiology has become the number ... have also spiraled to the number one ranking as ... than ever before as the most complete and reliable ... with lower back pain an MRI may confirm a ... pain, resulting in entirely different treatment protocols.  In these ...
(Date:5/9/2017)...  Semler Scientific, Inc. (OTCQB: SMLR), an emerging ... the clinical effectiveness and efficiency of healthcare providers, ... ended March 31, 2017. "We ... identify when preventive care options are appropriate, which ... attacks or strokes occur," said Doug Murphy-Chutorian ...
Breaking Medicine Technology:
(Date:5/24/2017)... ... May 24, 2017 , ... Adelberg-Montalvan Pediatric Dentistry ... for its patients on Long Island, New York. , Holistic dentistry puts ... is one of the biggest trends in dentistry today. , Dentist Dr. ...
(Date:5/24/2017)... ... May 24, 2017 , ... Dymedix® Diagnostics, Inc., ... today it had completed the first phase of building a global distribution network. ... of world (ROW) authorized dealers specializing in polysomnography accessories. The company plans ...
(Date:5/23/2017)... ... May 23, 2017 , ... Cambridge, MA, May 23, 2017—Total ... according to a Workers Compensation Research Institute (WCRI) study, a contrast from the ... System: CompScope™ Benchmarks, 17th Edition looks at indemnity and medical payments for ...
(Date:5/23/2017)... ... May 23, 2017 , ... The Gallery of Cosmetic ... is pleased to announce a new treatment option called Vivace Microneedling. This treatment ... neck, and body through a virtually pain-free, non-surgical treatment. Vivace Microneedling combines a ...
(Date:5/23/2017)... SC (PRWEB) , ... May 23, 2017 , ... New ... Dr. Kevin Hogan, an experienced dentist practicing in Mt. Pleasant, SC, with or without ... is often recommended for patients with missing teeth in Charleston, SC. Those ...
Breaking Medicine News(10 mins):