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Interventional Spine, Inc. Receives Expanded CE-Mark Approval of its PercuDyn™ Dynamic Stabilization System
Irvine, CA - April 26, 2007, -- 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™ 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™ 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™ System to be Launched at SAS Meeting in May
The Company will be introducing its PercuDyn™ 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™ 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™ 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™ System will be the focus of a workshop at the Spine Arthroplasty
Society meeting in Berlin titled: PercuDyn™-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.
FOR FURTHER INFORMATION CONTACT:
Lynda Milton
Office Manager
949-472-0006
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