Spine Surgeons Dr. Adelt And Dr. Bertagnoli Present Follow Up Data On Patients R

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Spine Surgeons Dr. Adelt And Dr. Bertagnoli Present Follow Up Data On

Patients Receiving The Coflex Interspinous Implant

http://www.medicalnewstoday.com/medicalnews.php?newsid=43714

Prominent German spine surgeons, Dieter Adelt, MD and Rudolf

Bertagnoli, MD announced encouraging results in separate studies of a

total 246 stenosis patients receiving Paradigm Spine's coflex

spinal implant. The surgeons spoke to more than 1,500 colleagues

attending the sixth annual Spine Arthroplasty Society (SAS) meeting

in Montreal last week.

The coflex device is a U-shaped titanium alloy surgical implant

indicated for use in patients with moderate to severe spinal

stenosis, with neural element compromise, resulting in claudication

and/or radicular symptoms isolated to 1 or 2 levels, in the region of

L1 to L5. It is currently classified in the U.S. as an

investigational device only.

Dr. Adelt, a neurosurgeon at the Ostseeklinik in Damp, Germany,

implanted 240 patients with the coflex interspinous device

between February, 2002 and November, 2004. His study evaluated 200,

or 83%, of the patients. Spinal stenosis was found in 76% of the

study group. Of these, Dr. Adelt said that 143 (86%) experienced

relief in severe low back pain sufficient to significantly increase

their walking distance.

Dr. Adelt commented, " These results indicate that the coflex

procedure allows patients to improve not only by decompressing the

neural structures but also by reducing back pain. "

He added that 91% of patients reported being satisfied or very

satisfied and 93% said that they would have the surgery again.

Dr. Bertagnoli, a surgeon at the ProSpine Centers in Straubing and

Bogen, Germany, presented to SAS attendees results of a 12-month

follow up on 46 patients treated with the coflex interspinous

implant. The patients, median age of 63, had been diagnosed with

secondary spinal canal stenosis, either with or without hypertrophic

facet joints. As some patients received implants at more than one

level, a total of 60 devices were implanted by Dr. Bertagnoli.

He reported that the results showed consistent reductions in six- and

twelve-month post-operative disability and pain scores compared with

pre- operative scores.

" The coflex interspinous implant offers a simple surgical

treatment strategy with a low risk potential. Not a single patient

was dissatisfied with the outcomes of their surgery, " Dr. Bertagnoli

reported.

Marc R. Viscogliosi, Chairman and CEO of Paradigm Spine, said: " Our

first priority is the patient and, with these results, I am very

optimistic about the potential for the coflex implant to improve

patients' quality of life without the need for radical surgery such

as fusion. "

" The coflex implant now has an impressive clinical history among

more than 15,000 patients being treated for low back pain and lumbar

spinal stenosis, " he added.

About Paradigm Spine, LLC

Paradigm Spine is a company focused on providing indication specific

posterior non-fusion solutions for orthopedic spine surgeons and

neurosurgeons focused on treating spinal conditions and diseases.

The company's founding philosophy is " Surgeon Centric, Indication

Specific, Data Driven " , and focuses on providing the best clinical

outcomes for patients suffering from chronic back pain. The Company

has 34 employees at its New York headquarters and office in

Wurmlingen, Germany, including a 7-member direct sales force in

Germany.

The company is concentrating on building a multi-product non-fusion

portfolio. The company's signature product is the coflex

posterior, non- fusion interspinous dynamically-functional implant.

The company is planning to implement in the U.S. a multi-center IDE

clinical trial of the coflex implant.

Paradigm Spine's other core platform is the Orthobiom technology,

also in development for over a decade. The Orthobiom technology

treats adolescent idiopathic scoliosis, a condition that causes

severe curvature of the spine that can be corrected surgically

through a spinal fusion procedure. The Orthobiom system is a non-

fusion alternative designed to preserve the motion and growth of the

child's spine. It is regarded as a revolutionary product with the

potential to help the tens of thousands of children diagnosed

annually with scoliosis.

Paradigm Spine, LLC was founded in 2004 by Viscogliosi Brothers, LLC.

(VB). Established by Marc R. Viscogliosi, J. Viscogliosi and

G. Viscogliosi in New York City, in 1999, VB is the first

venture capital/private equity and merchant banking firm dedicated to

the $26.4 billion musculoskeletal/orthopedics device sector of the

health care industry.

In total, the company has raised almost $30 million in three rounds,

including the latest Series C funding of $14 million, announced on

May 8th, 2006.

Today, VB is a leading independent firm, with a mission to create,

build and finance companies founded on innovations developed by

surgeons and uniquely focused on " life-changing "

musculoskeletal/orthopedic technologies. VB has worldwide surgeon,

industry and trade relationships and significant financial expertise

in the musculoskeletal/orthopedic sector. For more, visit:

http://www.paradigmspine.com.