NEW YORK, May 19 /PRNewswire/ -- 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(TM) 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(TM) 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(TM) 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(TM)
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(TM) 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-
"The coflex(TM) 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(TM) implant to improve patients' quality
of life without the need for radical surgery such as fusion."
"The coflex(TM) 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(TM) 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
Paradigm Spine's other core platform is the Orthobiom(TM) technology,
also in development for over a decade. The Orthobiom(TM) 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(TM) 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, John J. Viscogliosi and Anthony
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
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,
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
For more, visit: www.paradigmspine.com
SOURCE Paradigm Spine, LLC