Gyrus Group PLC - Re US Sales Approval
29 Januar 1998 - 11:40AM
UK Regulatory
RNS No 3074a
GYRUS GROUP PLC
29th January 1998
Gyrus Group PLC ("Gyrus")
US Approval (FDA 510 (k)) for VAPR(TM) T Arthroscopy System Two
Months Ahead of Schedule
SUMMARY
Gyrus, the "PlasmaKinetic" endosurgical device company,
announces US approval to commence sales of its new VAPR(TM) T
arthroscopic system. This product is to be sold under its
marketing alliance with Ethicon Inc. ("Ethicon"), a division
of Johnson & Johnson. The VAPR(TM) T system induces thermo-
responsive tissue modification which enables the re-modelling
of joint capsules damaged by repeated injury or recurrent
dislocation.
The VAPR(TM) T system has been approved for thermal modification
of soft tissue. This technique is used to re-model joint
capsules which have become overstretched through repeated
injury or dislocation. Recurrent dislocation of the shoulder
is a common sports injury and shoulder arthroscopy is the
fastest growing segment of the $162.5 million arthroscopy
market for VAPR(TM) products. As a relatively new treatment,
the range of three disposable VAPR(TM) T electrodes will attract
a 40% premium on end-user pricing compared to the VAPR(TM)
electrodes.
The first VAPR(TM) system was launched by Gyrus and Ethicon
during the second quarter of 1997. The introduction of the
new VAPR(TM) T product range, two months ahead of schedule, will
make Gyruss products the most comprehensive radiofrequency
("RF") energy system available for the arthroscopic surgical
market.
Mark Goble, Chief Executive commented:
"This meets the first product launch milestone planned
following our flotation on the London Stock Exchange in
November 1997, we are delighted to achieve this milestone two
months ahead of schedule. I fully expect this excellent start
to 1998 will result in the company exceeding turnover targets
for the year ending 30 June 1998."
In August 1996, the Group entered into a development, licence
and supply agreement with Ethicon, a division of Johnson &
Johnson, under which its Mitek. affiliate has exclusive
worldwide rights to market, distribute and sell the VAPR(TM)
system in the orthopaedic field. Mitek. specialises in
surgical devices for the repair of soft tissue injuries of
joints in the arthroscopic and sports medicine markets.
Sales of VAPR(TM) commenced with shipments to Mitek. in April
1997 and first end-user sales in July 1997 in the US. Roll
out to international markets commenced in October 1997.
As described in the Groups prospectus, further developments
to expand the VAPR(TM) product range were planned for the current
financial year ending 30 June, 1998. The first of these, the
VAPR(TM) T system has just received marketing clearance under a
510(k) pre-market notification to the FDA.
The VAPR(TM) T system has been approved for thermal modification
of soft tissue. This technique is used to re-model joint
capsules which have become overstretched through repeated
injury or dislocation. Recurrent dislocation of the shoulder
is a common sports injury and shoulder arthroscopy is the
fastest growing segment of the $162.5 million arthroscopy
market for VAPR(TM) products. As a relatively new treatment,
the range of three disposable VAPR(TM) T electrodes will attract
a 40% premium on end-user pricing compared to the VAPR(TM)
electrodes.
Studies performed in the US, have demonstrated that the thermo-
resistive control features of the VAPR(TM) T system produce the
rapid, predictable and repeatable elevation of tissue
temperature required to perform thermal modification of soft
tissues.
The VAPR(TM) T system provides an additional measure of patient
safety as depth of thermal tissue modification is less than
the other competitive monopolar RF technology on the market.
Unlike the Groups technology, this competitive monopolar
device is not capable of effective removal or contouring of
diseased or damaged tissue.
The versatility of Gyruss PlasmaKinetic technology therefore
eliminates the need for multiple RF units in the operating
theatre. The directors consider that the introduction of this
capability will make VAPR(TM) the most comprehensive RF-energy
system available within the arthroscopic market.
The Group is currently developing additional products to
further expand the VAPR(TM) product range as well as the Groups
other product range currently on the market; the VersaPoint(TM)
hysteroscopic system addressing the womens healthcare market.
An additional version of the Groups PlasmaKinetic technology
for urological surgery is planned for launch in Europe in Q2,
1998.
Notes to Editors:
Gyruss VAPR(TM) arthroscopic system is based on radiofrequency
(RF) energy. Using PlasmaKinetic endosurgical technology it
induces thermo-resistive changes in the saline which is used
to distend the operative site during minimal access surgery.
The capacity to adjust power in microseconds enables precise
control of two tissue effect modes.
In the first mode, an ionised plasma corona is created over
the active zone of a tissue treatment electrode. Tissue
entering the intense kinetic energy of the corona is
instantaneously reduced to its constituent elements and simply
washed away. The low thermal mass of the plasma prevents
collateral tissue damage adjacent to the application site.
In the second mode, as used by VAPR(TM) T, rapid predictable
and controlled elevations in tissue temperature can be
produced to modify soft tissue structures or seal blood
vessels.
Contacts:
Gyrus Group PLC 01222 300 100
Mark Goble
Buchanan Communications 0171 466 5000
Zena Bates/Tim Anderson
Panmure Gordon 0171 638 4010
Ronald Openshaw
END
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