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HydroCision Receives Two Additional FDA 510(k)
Clearances for SpineJetTM
ANDOVER, Mass., January 9, 2003 – HydroCision,
Inc. (www.hydrocision.com) announced today that the United States Food
and Drug Administration has granted 510(k) clearances to market its fluidjet-powered
burr and its bipolar electrocautery devices for open and minimally invasive
spine surgery. These regulatory clearances follow prior European Union
CE Mark certification and a prior U.S. regulatory approval of a fluidjet-based
soft tissue resection device for indications in the spine.
The SpineJet system combines selective removal of soft
tissue, such as the nucleus and annulus, with electrocautery to control
bleeding in the surgical field without having to exchange instruments.
The high-speed fluidjet-powered burr will further enable spine surgeons
to shape and remove hard tissue such as the lamina and bone while maximizing
control during their procedures.
“These two new product offerings will provide
the spine surgeon and their patients with a significant advancement for
open and minimally invasive discectomy procedures”, commented Doug
Daniels, President of HydroCision, Inc. “We believe the fluidjet-based
hydrosurgery system is a significant advancement in the spine surgeons’
surgical tools and will enable them to perform a number of existing and
new spine procedures more effectively, with greater ease, and with improved
economic outcomes.” HydroCision plans to enter the US and European
MIS spine markets in the second half of 2003.
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’. The Company
was incorporated in 1996, and has been funded from its inception by a
group of sophisticated venture capital firms and private investors. HydroCision
believes its proprietary fluidjet technology is the basis of a new surgical
modality because of its compelling features and versatility. The company
is developing a broad range of fluidjet-based devices to meet the needs
of multiple specialties.
HydroCision is a registered trademark of HydroCision,
Inc. VersaJet, SpineJet and The Leader in Hydrosurgery are trademarks
of HydroCision, Inc.
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