Navigation Links
DiFUSION Technologies Receives 510(k) Clearance of Xiphos™ Interbody Implants for Spinal Fusion
Date:10/6/2010

AUSTIN, Texas, Oct. 6 /PRNewswire/ -- DiFUSION Technologies Inc., a medical device company focused on the development and commercialization of its proprietary CleanFUZE™ anti-microbial technology for orthopedic implants, announced today the 510(k) clearance of its new Xiphos™ line of posterior interbody devices indicated for intervertebral body fusion of the lumbar spine, from L2 to SI, in skeletally mature patients who have had six months of non-operative treatment.  The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. The Xiphos™ System of implants is also indicated for use to replace a vertebral body that has been resected or excised (i.e. partial or total vertebrectomy) due to tumor or trauma/fracture.  The system is intended for the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental internal fixation.

"This clearance marks a milestone in DiFUSION's commercial pathway. Not only does it provide us an early stage revenue source, the Xiphos line is also a platform on which we will continue to develop our CleanFUZE line of fusion devices," said John Kaelblein, President of DiFUSION Technologies.

Spinal fusion procedures are common orthopedic procedures used to treat disorders of the spine including degenerative conditions, deformities, spinal trauma and tumors. In fact, in 2009 over 500,000 spinal fusion procedures were performed in the US, a figure growing by over four percent annually. One of the implants often used in these procedures is the interbody fusion device, the market for which is now approaching $1 billion. The Xiphos line of interbody devices is DiFUSION's entry into this segment.

"The Xiphos posterior interbody platform includes an array of implant shapes and sizes for varying patient anatomy and surgical preference allowing for posterior, posterior oblique and transforaminal approaches," remarked Dr. Jami Hafiz, PhD, VP of Development for DiFUSION Technologies. "We really focused on developing a best in class series of implants that could serve as a platform for future development."

About DiFUSION Technologies

Founded in 2008 in Austin, Texas, DiFUSION Technologies, Inc. is a medical device company focused on reducing the rising incidence of surgical site infections in orthopedic and spine surgery through the development of a suite of patented antimicrobial orthobiologic polymeric implants. Initially focusing on the multi-billion dollar spinal implant market, the company has developed a technology with applicability across a variety of orthopedic segments using well characterized implants with benefits for the patient, surgeon, hospital and payer. For more information about DiFUSION Technologies, visit www.DiFUSIONtech.com.

CleanFUZE orthobiologic polymers have not been approved by the US FDA. CleanFUZE is not available for sale within the United States.


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

Related medicine technology :

1. Emisphere Technologies, Inc. Announces 2007 Second Quarter Financial Results
2. King Pharmaceuticals and Palatin Technologies Delay Immediate Plans for Phase 3 Clinical Program With Bremelanotide for Erectile Dysfunction
3. Rockwell Medical Technologies, Inc. Begins Patient Enrollment for its SFP Dose-Ranging Study
4. Rockwell Medical Technologies, Inc. Begins Dosing Patients for SFP Phase IIb Clinical Study
5. New Clinical Studies Confirm Mauna Kea Technologies Cellvizio(R) GI in Range of Procedures
6. Palatin Technologies, Inc. Reports Initiation of Human Trials for the Treatment of Congestive Heart Failure
7. Emisphere Technologies, Inc. Announces 2007 Third Quarter Financial Results
8. Senesco Technologies Initiates Preclinical Studies for Cancer Target
9. ASEAN News: Epeius Biotechnologies Gains Commercial Approval for Rexin-G(R), a Tumor-Targeted Gene-Based Medicine for Metastatic Cancer
10. Epeius Biotechnologies Applauds the Belated Scholarship of Their Academic Contemporaries in 2007, As Targeted Gene Therapy Comes of Age in Clinical Medicine
11. TCS Healthcare Technologies Releases Three New Clinical Care Programs Within ACUITY
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/23/2017)... , Mar 23, 2017 NeuroVive Pharmaceutical ... today announced that the English version of the Annual report ... www.neurovive.com .  ... About NeuroVive NeuroVive Pharmaceutical AB is a ... discovery and development of medicines that preserve mitochondrial integrity and ...
(Date:3/22/2017)... -- Research and Markets has announced the addition of ... Industry Forecast to 2025" report to their offering. ... The Global Respiratory care ... 10.9% over the next decade to reach approximately $38.27 billion by ... and forecasts for all the given segments on global as well ...
(Date:3/22/2017)... Under the impetus of the fast-growing ... increased year by year at the CAGR of ... market size will maintain the growth rate of ... billion in 2021, thanks to severe aging, the ... agents and supporting policies. At present, Chinese ...
Breaking Medicine Technology:
(Date:3/23/2017)... New Jersey (PRWEB) , ... March 23, 2017 ... ... developer of herbal-based and non-steroidal skincare products, was awarded as winners of American ... innovation products. This competition was hosted jointly by HSN and Good Housekeeping. , ...
(Date:3/23/2017)... ... 23, 2017 , ... The Boulevard is honored to host Shriners and Masons ... be located in the Main West Entrance of The Boulevard (in front of JCPenney). ... is necessary and each child with a parent or guardian will be photographed for ...
(Date:3/23/2017)... ... ... “Beyond and Back”: a true-life testimony of tragedy and the miraculous power ... Rose, a wife, mother and grandmother committed to sharing her many spiritual adventures which ... new book presents actual events in the life of her family, which validate her ...
(Date:3/23/2017)... (PRWEB) , ... March 23, 2017 , ... ... has selected HealthiPASS, an innovative patient - centric payment system, to expand its ... massive improvements in the patient financial experience. , “At Ogden Clinic, we ...
(Date:3/23/2017)... ... March 23, 2017 , ... “More Corruption”: a simple and strong explanation of the God’s ... the rulers of Heaven was asked by God to write a book about Him. , ... just because I kept my commitment to the Lord God. They have not walked in ...
Breaking Medicine News(10 mins):