Contacts: Anthony Viscogliosi or Michael Will Nick Kilsby
Spine Solutions Inc. (212) 750-2099 EKK (203) 406-8800 ext 21
SPINE SOLUTIONS REPORTS RAPID GROWTH IN PRODISC
IMPLANTS AND QUALIFIED SURGEONS IN 2002
New York, NY – January 7: Spine Solutions, Inc., the maker of
ProDisc, the leading total artificial disc replacement system, reported
sharp increases in 2002 of qualified surgeons and implantations of ProDisc.
Worldwide, during the year, more than 200 surgeons in 24 countries performed
the procedure compared with 33 during 2001, resulting in sales of more
than 2000 ProDisc products compared with 350 in 2001.
Germany is currently leading the world in the use of artificial discs
as an alternative to fusion techniques for treating chronic degenerative
disc disease of the spine. In 2002, surgeons there have performed more
than 1,500 ProDisc implantations, an increase of more than 1,115 over
2001, according to Anthony G. Viscogliosi, CEO of Spine Solutions. “We’re
seeing the fruits of more than a decade of development in a technology
that promises to be the new gold standard for treating chronic back
pain. In the US, ProDisc is in FDA Investigational Device Exemption
(IDE) clinical trials at 16 medical centers with a target enrollment
of up to 500 patients. Data permitting and contingent upon Pre-Market
Approval (PMA), we expect ProDisc to be available commercially in the
U.S. by 2005 or sooner,” Mr. Viscogliosi said.
A recent German court decision to nullify a patent held by Waldemar
Link GmbH & Co. is thought to have helped heighten interest in ProDisc.
“We believe that the momentum is being supplied by spiking interest
among leading surgeons and university hospitals. As a result, we’re
hopeful that the use of ProDisc will be confirmed as the standard procedure
in all spine surgeries that meet established indications,” according
to Michael D. Will, EVP/International Operations at Spine Solutions.
Separately, Spine Solutions announced that its ProDisc ‘C’
cervical disc replacement system had received a European Union CE Mark.
Dr. Rudolph Bertagnoli, in Straubing, Germany and Dr. Thierry Marnay,
in Montpellier, France are participating in a series of clinical trials
of the ProDisc ‘C’ cervical disc replacement system that
commenced in December, 2002.
The ProDisc total disc replacement system for use in both lumbar and
cervical (or neck) regions of the spine is designed with materials long
used in orthopedic implantation devices, including knee and hip replacements.
It consists of three elements: a core of ultra-high-molecular-weight
polyethylene that attaches to the top and bottom pieces of two cobalt-chromium
The system is designed to restore near natural range-of-motion, kinematics
and biomechanics of the spine. Cases-to-date indicate a significantly
shorter hospital stay and faster post-operative recovery period compared
to fusion surgery.
Spine Solutions, Inc. is a privately held company established in 1999
and based in New York City.
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