Allium Group receives CE Mark for next-generation prostatic stent
31 January 2009
Allium Group has announced that it has been awarded CE mark for its
prostatic stent, enabling commercialization of the system in the
European Union and the countries that recognize the CE Mark.
"We are excited about receiving the European CE approval for our
Prostatic stent. This achievement confirms the innovativeness and
advantages of our stent technology and brings us closer to offering
patients solutions that provide them with efficacious and immediate
treatment, convenience, comfort and quality of life," said Limor
Domnitz Gishri, CEO of Allium Medical.
"Allium Medical has had a great deal of success in Europe with its
biliary and ureteral stents that received CE marks and begun to market
in 2007 and we believe that our prostatic stent will quickly become the
"must have" solution for physicians and hospitals in Europe."
Allium's Prostatic Stents, used in patients with benign prostatic
hyperplasia (BPH) or with advanced prostate cancer, have a triangular
cross-section to match the contours of the prostatic urethral lumen and
have the ability to exert varying degrees of radial force depending on
the anatomy and function of this part of the male urethra.
For example, higher radial force in its main body and lower radial
force in the area near the external sphincter to prevent sphincteric
dysfunction causing incontinence. These characteristics enable the
Allium Prostatic Stents to conform to the prostatic urethral shape and
function and offer a much improved comfort than existing stents in the
"Today the leading treatment options for BPH demand continuous
treatment pharmacological or surgical interventions which become
expensive and uncomfortable. Such treatments may result in undesirable
side effects such as erectile dysfunction (ED) retrograde ejaculation
(dry orgasm), and, at times, bladder control problems," said Prof.
Daniel Yachia, founder and CSO of Allium Medical. "We at Allium worked
closely with physicians on the development of this stent and understood
the need for a new minimally invasive, reversible and non-surgical
office procedure that they can offer their patients."
Allium's stents are currently being distributed through numerous
partners in various European markets including Italy, United Kingdom,
Germany and Austria, Benelux, Spain, Greece, Scandinavia and South
"We are excited to be able to provide the medical community,
physicians and patients, Allium's prostatic stent that will change the
way BPH is treated in Europe," said Frank Menke, CEO of MenkeMed, the
leading medical equipment distributor in Germany. "These stents are
revolutionary in that they allow for a minimally invasive ambulatory
procedure with immediate results. They are long-term temporary stents
that can be inserted for up to 12 months and are easily removed making
the procedure quick, efficient and cost-effective."
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