Healthcare Industry News: lumbar spinal stenosis
News Release - April 26, 2007
Interventional Spine, Inc. Receives Expanded CE-Mark Approval of its Percudyn(TM) Dynamic Stabilization System
IRVINE, Calif.--(HSMN NewsFeed)--Interventional Spine, Inc. announced today it had recently received CE Mark approval from its European Union Notified Body for expanded indications for use beyond its original focus."These broad indications for use more than double the market potential for Percudyn(TM) outside the U.S. and expand the indications from our original approval for Degenerative Disc Disease in November 2006," stated Interventional Spine, Inc. CEO Walter A. Cuevas. "We believe that our truly percutaneous approach will provide additional benefits to patients and surgeons alike and will become the standard of care for patients suffering with DDD." Mr. Cuevas continued: "In our pilot clinical trial, the Percudyn(TM) System has been percutaneously implanted, providing support to the articulating facets through bilateral usage at multiple levels in the lumbar spine, in less than one half hour. In one year follow-up, these patients remain pain-free."
Percudyn(TM) System to be Launched at SAS Meeting in May
The Company will be introducing its Percudyn(TM) System to the European market at the Spine Arthroplasty Society in Berlin, Germany on May 1 through 4. With this launch, Interventional Spine's Percudyn(TM) System becomes the world's only truly percutaneous extension limiting device for the treatment of:
- Mild to moderate Degenerative Disc Disease (DDD) of the lumbar spine
- Neurogenic intermittent claudication (NIC) due to lumbar spinal stenosis
- Spondylolisthysis
- Baastrup's syndrome
- Axial load inducing back pain
- Contained herniated nucleus pulposus (HNP)
- Adjacent level support as an adjunct to fusion therapy
Percudyn(TM) has been engineered to complement the features of Interventional Spine's Teleport® Tissue Retractor, another proprietary Company technology, and is an integral part of a percutaneous implant methodology that has been designed and qualified to advance the current clinical state of the art for the widest possible number of patients.
"With this launch, Interventional Spine is now positioned to rapidly strengthen its Management team and expand the Company's European Distribution Channel, while focusing increasing marketing resources on sales training and customer education opportunities," Mr. Cuevas concluded.
The Percudyn(TM) System will be the focus of a workshop at the Spine Arthroplasty Society meeting in Berlin titled: PERCUDYN(TM) - The Percutaneous Answer to Dynamic Stabilization, on May 3rd.
Interventional Spine, Inc. is a privately held company based in Irvine, California. More information on the Company and its other products can be found at: www.i-spineinc.com.
Source: Interventional Spine
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