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HydroCision Receives FDA 510(k) Clearance for
SpineJet Perc Resector™ for Hydrodiscectomy™ Using the SpineJet
Hydrosurgery System™
ANDOVER, Mass., September 25, 2003 – HydroCision,
Inc. (www.hydrocision.com) announced today that the United States Food
and Drug Administration has granted 510(k) clearance to market its SpineJet
Perc Resector for Hydrodiscectomy in minimally invasive spine surgery.
The SpineJet Perc Resector is the first non-thermal fluidjet-based surgical
instrument specifically designed for minimally invasive percutaneous microdiscectomy.
The device will allow spine surgeons to quickly and effectively complete
decompression through a miniature cannula without the thermal effects
of other powered instruments. The procedure will be performed on an outpatient
basis under local anesthesia allowing patients to return home the same
day with minimal post-operative pain and recovery time.
“We have made significant strides in 2003 executing
our corporate development strategy to provide a vast portfolio of SpineJet
devices for spine surgeons, and to improve the results of a wide array
of the spine procedures they perform. The SpineJet Hydrodiscectomy device
will be our initial entry into the rapidly growing percutaneous microdiscectomy
market, and is a great complement to the SpineJet Resector™ and
Curette™ devices,” commented Doug Daniels, President
and CEO of HydroCision, Inc. “From microdiscectomies to fusions,
we believe the SpineJet family of devices will allow spine surgeons
to perform spine procedures faster, more effectively, and less invasively
than with instruments currently available."
The SpineJet Perc Resector
device leverages HydroCision's patented non-thermal Hydrodrive™ fluidjet-based
technology to simultaneously collect and remove nucleus tissue from
the disc with a single-powered instrument while preserving the surrounding
tissue. The minimally invasive procedure can be performed through a
needle-sized cannula thereby minimizing patient post-operative pain
and recovery time. HydroCision plans to launch several additional versions
of both the SpineJet Perc Resector and the recently introduced family
of SpineJet Curette devices during the next few months.
About HydroCision
HydroCision is the leading developer, manufacturer and
marketer of fluidjet-based surgical tools that are the foundation of a
new surgical modality – ‘hydrosurgery’. Hydrosurgery
improves patient care by selectively removing tissue, minimizing collateral
damage and bleeding, and promoting the healing process. HydroCision believes
its proprietary fluidjet technology is the basis of a new surgical modality
because of its compelling features and versatility. Incorporated in 1996,
the company continues to develop a broad range of fluidjet-based devices
leveraging the HydroDrive™ to meet the needs of multiple specialties.
Current investors include Zero-Stage Capital, Newbury Ventures, and Oxford
Bioscience Partners.
HydroCision is a registered trademark of HydroCision,
Inc. SpineJet, SpineJet Resector, SpineJet Perc Resector, SpineJet Curette,
Hydrodiscectomy, HydroDrive, and The Leader in Hydrosurgery are trademarks
of HydroCision, Inc.
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